Category: Clinical Trials (CRO)

Early-phase clinical studies range from simple to complex, and all must be conducted rapidly while maintaining subject safety and data quality. They are also generally not performed in isolation, and they lay the foundation for future studies to further our understanding of drug metabolism and safety in support of a new drug candidate. Partnering with a trusted contract research organization (CRO) like PPD enables our sponsors to benefit from decades of early-phase experience, extensive global reach, and broad service capabilities.

Our expertise spans across all development phases, offering a program solution to small biotech clients. PPD can offer the flexibility needed to apply evolving strategies to the management of early-phase studies involving novel medicines and ensure that sponsors have access to study strategies that will be optimal in terms of time, quality, and cost from early phase through to registration. 

Start with Understanding the Study Drivers

Early-phase first-in-human or clinical pharmacology studies are conducted to understand the metabolism and safety of a new drug candidate. The goal is to ensure that the drug and the dosing regimen are safe and maximally efficient while identifying potential biomarkers to provide insight into efficacy for later-stage studies.

Every early-phase study is different, and each will always have very specific endpoints. Our job is to work with our sponsors to establish the key drivers for their study so we can build an effective strategy that supports their vision. For some clients, study cost may be the primary driver, but, in some situations where the study is on the critical path to a market application, delaying time to market would have much higher cost implications. 

Understanding the forces behind early-phase studies helps a CRO like PPD develop a solution that best meets the sponsors’ needs. Some sponsors have a fixed idea of process and outcome and are just looking for a CRO to provide a practical study design that delivers the study quickly and efficiently. In other situations, the overall future clinical development program timeline may be the corporate focus, therefore building into the phase I first-in-human study a patient cohort to provide early insight to proof of concept can help secure funding for future clinical development or inform clinical endpoints in later-phase study designs.

Then Move to Proper Planning

Early-phase studies are just that — the first step in the clinical development process. For some, they lead to the next study on the way to getting a new drug product licensed/approved as quickly as possible. For others, like small biotechs, it may involve establishing proof of concept in order to attract investors or licensing partners. The best CROs, like PPD, are ones that can bring to the table solutions for the entire development life cycle and treat these early-phase studies as part of a broader development program. 

Risk management is an essential aspect of strategic planning for these studies and programs. Some sponsors like to be aggressive, taking risk with conducting studies and activities in parallel in order to move as quickly as possible, while others prefer the security of time and cost, with contingency planning included in fixed price for fixed-scope budgets. The former may not want to bother with any backup solutions; the latter may require additional backup options built in up front, which may comprise additional sites or cohorts.

PPD builds a strategy according to the client’s needs, risk tolerance, and expectations, leveraging our expertise and understanding of the complexities of the study design and the capabilities of the sites involved. The functional groups involved in each study establish risk-mitigation plans up front for potential problems that our project managers — through ongoing meetings with those groups — continually monitor based on the level of risk in order to trigger timely backup plans.

Communicate Effectively

Project managers are the experts in communication, ensuring timely and effective communication across functions and between stakeholders. They set clear expectations for timelines, interdependencies, and responsibilities. All team members must understand the implications of timeline shifts in their areas of responsibility for other downstream functions. Project managers establish communication plans from the start and appropriate escalation steps for each functional area so the entire project team can be notified appropriately in a timely manner. If issues become more urgent, the right senior leaders can be engaged immediately to help secure timely solutions. 

Establish the Right Team

Upfront triage with an integrated team is also critical to the success of early-phase studies. That team should be constructed based on the elements that are important to the study and sponsor. For clients looking for proof of principle, engaging the later-phase team, particularly colleagues with therapeutic expertise, in the discussion is important. 

At PPD, our development physicians assess each protocol and provide medical considerations based on their therapeutic indication expertise in consideration of the patient population and the endpoints that need to be factored into a study to ensure the best strategy to deliver results, consistent with standard of care. Having representation from site principal investigators in different regions, even if some of the sites may not enroll many patients, provides an opportunity to get the endorsement of additional key opinion leaders and ensure consistency with standard of care across regions and patient types. 

The PPD team includes lab and pharmacokinetic experts, ensuring that suitably validated assays are used to make effective go/no-go decisions at early stages in a program. Including global team members on the early-phase study teams is also recommended for candidates for which sponsors will ultimately be seeking global registrations. These experts can help ensure that endpoints for the study will meet regulatory acceptance across the world.

Expect Change

While there is a standard set of clinical study designs that are predictable and consistent in early-phase studies, there are often unique challenges arising from rapid timeline expectations. As a result, systems, processes, and ensuring teams have the flexibility to adapt quickly to change are key to success and to ensure that solutions are customized for each client and opportunity in order to manage speed while ensuring the quality of the study outputs. Experts with the right mindset who understand the expectations and can work flexibly when problems arise are essential, as are pre-developed solutions that can be readily implemented.

Leverage Broad Systems to Form Deep Partnerships

For early-phase studies that are part of a program designed to result in a new drug product approval, it is important for the CRO to have systems in place that provide a portfolio view of each study within the overall program. Both the early-phase and late-phase teams need to have an understanding of where the studies they are involved in are on the critical path to an overall submission timeline. 

Within PPD, our systems and processes enable the necessary understanding of sponsor goals and provide the appropriate level of oversight and management. Combined with our approach to program performance management and commitment to communication, we can help clients identify the right development pathway and stay on track. For small biotechs, we are able to supplement their teams with expert resources in each function or region to provide a wealth of skills and experience to match any large pharmaceutical company. When clients partner with PPD through our program approach, they benefit from our consultancy services, strategic and regulatory guidance, global outreach, and breadth of experience that is not possible to afford on an individual study basis.

The support PPD provided to companies developing COVID-19 therapies and vaccines is a great example of bending the time–cost curve to achieve sponsor and public health goals. Going from concept to a licensed vaccine in less than 12 months could not have been possible without a robust CRO/sponsor partnership and a joint commitment to expediting the clinical development strategy. Rather than separate phase I, II, and III studies, we worked with clients and regulators to ensure early clinical endpoints to inform later-phase studies and achieve seamless transition across formal phase I–II/III study phases using combined protocols. The expedited timelines and parallel development approach could not have been achieved without working with a single CRO that can provide all of those services in a programmatic fashion.

Global Reach, Experience, Expertise, and Integrated Support

PPD’s early development services team are often the first interaction a client has with PPD and serves as integrators to the broad range of services PPD offers. We can help with project management, lab analysis, and building a clinical development plan across phases and regions. As a multi-solution provider, PPD support sponsors with everything they need to bring their products to market — and beyond.

We are also equipped to take on entirely new projects, which we demonstrated during COVID-19. PPD was able to align its experience with problems arising from the pandemic and develop optimum solutions. We can tackle treatments for new rare genetic diseases and studies involving novel drugs with first-in-class mechanisms of action. Providing strategic guidance on clinical development is a core skill set and a differentiator for PPD. In addition, our experience, combined with our relationships with 30 partner sites in all regions across multiple countries, makes it possible to build the best possible strategies for sponsors in terms of time, quality, and cost. We are a trusted partner that adeptly delivers results in any indication.

Originally published on PharmasAlmanac.com on August 17, 2021.

Cancer centers need to ensure they have sufficient staff, the appropriate technology, and the right patient population to conduct clinical trials — both to contribute to oncology clinical research and to provide the full range of treatment options to their patients. Marie E. Lamont, General Manager of Inteliquet, discusses how the company’s tools assist cancer centers in assessing the appropriateness of specific clinical studies for their sites and in finding the right patients to participate in the trials they do conduct, in conversation with Pharma’s Almanac Editor in Chief David Alvaro, Ph.D.

David Alvaro (DA): Can you introduce us to Inteliquet — from the company’s genesis and through any major inflexion points to the work you are doing today?

Marie Lamont (ML): Inteliquet was originally founded as TransMed Systems, which sought to help translation medicine labs with a business information system for oncology research. However, the market wasn’t yet ready for that offering, so in the company pivoted in 2015-2016 to explore how to help cancer centers make better, data-driven decisions. At the time and continuing to today, this was an acute challenge, given that electronic medical records (EMRs) didn’t collect data in a consistent way, so there was a need to translate and harmonize all these data to make them usable. The company began structuring the database to help match patients to clinical studies. When I came onboard in late 2019, we began re-evaluating our purpose and determining how we could best leverage our technology and data structure to truly help cancer centers.

In 2021, the company merged into IQVIA, a global organization also interested in using technology to enable healthcare and to help health systems reduce their administrative burden and make data-driven decisions. The purpose of Inteliquet has not changed at all since we became part of IQVIA: we work with cancer centers to help them make data-driven decisions, and IQVIA has encouraged Inteliquet to continue to do just that.

DA: Can you expand on the current challenges that cancer centers face and how Inteliquet helps reduce some of their burdens?

ML: Inteliquet thinks about the workload associated with finding patients for clinical trials. Thirty years ago, it was easy. There were fewer clinical trials, and they were not nearly as complex. Today, there are numerous biomarkers and disease stages — we calculated potentially 20,000–50,000 permutations. When you think about the types of studies with all those biomarkers and all the other measurements, it makes the work incredibly complex.

I am not sure that the industry — EMRs, hospitals, pharma companies, CROs, and so on — has done enough to help frame that out. A lot of the information exists as PDF files and in physician notes as free text. Globally, data cannot easily and quickly be accessed and leveraged by someone in a healthcare setting. For a cancer trial, for instance, if a person must have four relevant biomarkers to qualify for a given study, it is necessary to dig through the patient records to determine whether that is the case.

Inteliquet helps to speed the process along, reducing the burden on administrators by making data retrieval more efficient and effective, thereby also making it possible to reach decisions faster. If a sponsor or CRO proposes a new study to a cancer center, the center must conduct a feasibility assessment. Some sites call each primary investigator to determine how many potential patients they have. The individual estimates then have to be aggregated. We offer tools to perform that feasibility study electronically using patient data. It is not perfect, as staffing and patient data are constantly changing over time. But it provides the most accurate analysis at that time, and the center can make an informed decision about investing in the new study more quickly and with less consumption of human resources.

If the cancer center decides to participate in a new study, once it is set up, patients must be found. Finding patients is generally conducted in two ways: through a patient list obtained from a broad search using top-level criteria or via patient-matching using in-depth digitalized patient data. Inteliquet performs the digitalization under a confidentiality agreement, saving cancer centers time and effort up front. In essence, we are compressing the workload, which allows these centers to be more efficient and effective.

This approach benefits CROs and sponsors as well because they know that, if a cancer center says yes to a study, it means that center has the necessary patient population. Studies can be onboarded more quickly as well, which means giving hope to patients as fast as possible, which is also important.

DA: Can you expand on the considerations or limitations that are holding cancer centers back from fully participating in clinical trials?

ML: The complexity and administrative burden of clinical studies are issues, as are costs. There is a huge diversity of cancer center types, and not all of them have the staff or the resources to engage in clinical research. It doesn’t mean they’re not important — they are doing patient-facing care, and they are maniacally focused on helping those patients.

But research and clinical studies require investment, and it’s a lot of investment. Cancer centers need to be compliant with the FDA’s requirements to conduct clinical studies. Not all centers are ready to achieve that, and some might not have enough patients to justify the investment. Most are already dealing with many different systems and tools, and adding another may not appear worth it, at least for the near term. Some do beautiful work with patients but might just not be ready. Our work can lower the barrier to entry, but each center needs to determine if and when to make the change.

Some cancer centers may also be worried about compliance with data privacy regulations (e.g., HIPAA). They may be concerned about how the data are going to be used and may not fully understand how these digital tools can help patients. Certainly, some are more conservative, particularly if there has been a prior HIPAA issue.

With respect to interest in Inteliquet’s offering, there are smaller centers that do not have the time to implement a digital tool and big centers (particularly academic medical centers) that want to build their own tools. There are also competitive tools on the market, and there is an interesting decision stream. Nobody wants to be the first, a first adopter — the first to explore an unknown. The larger cancer centers will generally only be comfortable using a new product if they participated in its development and have staff that are already trained on how to use it.

There are many cancer centers that use and like Inteliquet’s offering. They have used the digital tools for a number of years and can effectively leverage our solutions. They have made that investment in the product, IT staff, and general staff training to maximize the possible benefits.

DA: Where are we presently in the course of the paradigm shift from viewing clinical trials as a primary care option rather than a last resort?

ML: We are watching an evolution toward targeted medicine, with the percentage of patients receiving standard of care (chemotherapy and radiation) changing over time because chemo and radiation have toxicity associated with them. There are growing numbers of studies involving novel therapeutics in combination with chemotherapy or radiation, but the overall shift is toward targeted therapeutics that only attack tumor cells.

Of course, we’re also looking at cell and gene therapy as potential options. Those are quite costly, however, and the cost needs to come down over time for them to truly become viable and valuable options in cancer. In the meantime, the onus is on the industry to demonstrate the value behind those costs.

Overall, for patients, it means they will increasingly have the choice of receiving a targeted therapeutic via a clinical trial versus chemo and radiation. Clinical studies are more and more often being seen as a primary care option because participation in studies of targeted therapies has the real potential to extend the patient’s life.

What is particularly exciting is that there is still so much being learned about biomarkers, which is leading to even better targeting. Understanding is also growing about which biomarkers work synergistically and which do not play together well, which is driving the development of combination therapies that are also evolving.

DA: How does the overall industry move toward decentralized clinical trials models — particularly in the wake of COVID-19 – align or synergize with the work Inteliquet does?

ML: Broadly, because of sizing — they’re smaller and don’t have the staff — many community centers haven’t been able to conduct clinical studies or, if they are interested, have not been selected by sponsors, who tend to look toward the big academic medical centers because they are cheaper. However, there has been recognition that this fails to provide sufficient access to patients. I saw one report that found that, while 85% of cancer patients receive treatment in the community setting, less than 5% of cancer patients in studies occur in a community setting. Clearly, patients with access to large academic medical centers have more access to studies.

That definitely leads to disparity. We need more diversity from economic, geographical, cultural, religious, and racial perspectives. The tools that can help community cancer centers will help drive sponsors into those sites and ultimately ensure a more diverse patient population. The tools don’t care about age, religion, or race; they provide a list of patients that match a particular study’s deep protocol criteria, the inclusion/exclusion criteria. Because they help smaller community centers perform patient matching faster and more efficiently, they allow a wider population of patients to participate.

I should mention that we have seen many larger health systems make deals with small cancer centers that enable those small cancer centers to participate in clinical studies. However, those patients still have to drive to an academic medical center. Consequently, a certain amount of unintended bias inevitably enters the picture, because only those people who can afford to take the time to drive into those academic medical centers are able to participate. That still leaves a need for trials to take place within community centers.

This is a priority, and not just because of the altruistic mission to increase diversity and equity in clinical trials. There is also a crucial need for diversity to ensure that data is representative of the patient population and that trials truly represent the population that will be using the new therapeutic once it has been approved.

Furthermore, choice is important. I have family members who have had cancer who had to receive radiation and chemo because they were the only option for them. I want to make sure that everybody has real therapeutic options. That’s the best of all worlds. It could be a clinical trial; it could be a cell and gene therapy. But you want folks that you know to have a choice. Decentralized trials at community cancer centers are one way to make that happen.

DA: Can you speak a little bit about the underlying technology that is enabling Inteliquet to accomplish its goals?

ML: The data engineering team at Inteliquet maintains a focus on how to bring data in a thoughtfully organized and structured manner and then uses artificial intelligence (AI) in a learning environment to constantly improve the solution. New biomarkers are being discovered all the time. New disease pathways and mechanisms are being uncovered within particular types of cancer. Those new biomarkers won’t be used commercially until the FDA approves therapeutics based on them, but they are often used in increasing numbers of clinical trials as positive data is generated.

AI helps with that journey. It may even help move it more quickly by examining all the measurements being collected and assessing whether they are indicators and whether candidates based on those biomarkers are having an impact. Inteliquet is part of a consortium that shares these types of data so that they can be aggregated, and trends can be identified.

DA: Does the AI technology itself need to continue to evolve, or is it sufficiently advanced and more a question of further training with data going forward?

ML: Both. It is essential to continue to train AI tools and ask the right questions. It is also important to push the technology forward. Indeed, in the future AI has the potential to provide clinical decision support. Regulations are being developed around medical technology as a device because it could influence care decisions. That creates an obligation for me. If a technology is going to influence care, there is an obligation to make sure that the AI continues to evolve — not just learning on set topics, but fundamentally evolving with respect to capabilities.

DA: Can you discuss the OncWeb software and the pragmatic user experience for the cancer centers that use the technology?

ML: When a cancer center deploys the OncWeb tool, it goes through a process of ingesting the patient data. Inteliquet works with the center to make sure the appropriate data points are coming in on a consistent basis, because of course time is of the essence. Once that step is completed, the system is up and running. Our clinical engagement specialist team works with the cancer centers on an ongoing basis. When asked, we digitalize clinical trials and structure the workflow in a manner that works best for the center and the trial. Patient data collection can be tied to specific events, such as cancer clinics, or testing result reporting, such as pathology reports and genetic testing. The data is used to identify patients on a watch list that are then evaluated as potential matches.

Ongoing communication with cancer centers helps drive innovation at Inteliquet. We constantly add new workflows into the tool in order to provide the capabilities the cancer centers need. For each cancer center, the tool takes into consideration what is done at the site and what information the site prefers to use to develop the watch list. For instance, with one cancer center, Inteliquet is currently testing an intriguing surgery workflow that enables a very unique decision-making process.

In essence, Inteliquet wants to partner with cancer centers to ensure that OncWeb continues to evolve in ways that help improve their workflows. The key is to look at the assistance the cancer center is seeking and to meet those specific needs, whether that is just for conducting the feasibility study or if it also involves patient finding. In fact, during the COVID-19 pandemic, our clinical engagement specialists who are former research coordinators or nurse navigators helped cancer centers to prescreen patients. We still offer that service occasionally today, because Inteliquet’s goal is to help our partners.

DA: What do you see as the long-term evolving benefits of digitalization for cancer centers?

ML: In the industry, there is more focus on the use and reuse of data to make decisions. That is piece one. The FDA and the EMEA are also having more conversations about comparator data (real-world data); for example, about a trial arm being completely comparator data. We’re going to see that happen more and more. There is more confidence in the data as well. The evolution toward decentralized studies, both interventional and real-world studies, will continue. The COVID-19 pandemic heightened this trend, but there is more work to be done.

The use of technologies and new opportunities for the use of technologies will continue to increase as well, particularly for enabling decentralized studies, whether they are actual trials or analyses of real-world data. The focus on patient-generated data — wearables, diagnostic tools, patient-reported outcomes, etc. — will expand, too.

As these changes occur, Inteliquet’s tools can still be used because the goal is to match patients to a study, regardless of whether it is traditional or decentralized, based on a wide diversity of data and agnostic of the source (physician, diagnostic result, or patient-reported).

In addition, the need for data collection from many different sources will be ever greater. Those data will be inconsistent but when aggregated have the potential to unlock new disease applications for existing drugs, as well as new approaches to treating well-known diseases. Fortunately, we are also seeing more emphasis placed on the cleanliness, credibility, and consistency of the data used by digitalized tools.

DA: How does having support from the larger IQVIA organization aid in Inteliquet’s mission?

ML: With Inteliquet as an interface between cancer centers and IQVIA, it is possible for us to learn about clinical trials that can be brought to our cancer center customers, which provides an intriguing opportunity for the centers to access options they might not have had before. That IQVIA is focused on connected intelligence and data means Inteliquet has access to tools and technology that can be woven into our system and become incredibly valuable options for our customers. For instance, IQVIA’s work on remote source data verification could potentially reduce the burden on cancer centers. Finally, IQVIA’s relationships with sponsors and cancer centers also add value to the Inteliquet team.

DA: When you look to the future, what sort of innovations, inflexion points, or paradigm shifts do you see on the horizon for cancer care or that might impact what Inteliquet is able to do? How will that fit into an evolving model of cancer care and clinical trials?

ML: Setting aside the need for more trials across a wider geographical spread to ensure more diversity, I see more decentralized studies taking place — it is just a question of time and speed and how they will be structured. Tracking patients over time will become more important because it is increasingly recognized that long-term follow information is critical, not just in cancer but for all disease indications.

Discoveries in one part of the world need to migrate more quickly to other parts of the world — because we are talking about people’s lives; the industry needs to facilitate that communication. The increased crackdown on counterfeit drugs that was achieved during the COVID-19 pandemic needs to continue.

Over the next five years, I expect the use of AI in drug discovery and development to expand. The more we dive into biomarkers and the layers beneath them, the more that AI is needed to quickly identify therapeutic options. Comparator studies, which are already being encourage by regulatory agencies, will continue to increase, while the use of placebos will decrease — a good development for patients of all kinds.

Patients will also continue to be more vocal about what they want and expect, including with respect to clinical trials. New tools and technologies are being developed specific to help patients match themselves to trials. This trend will continue, and not just in the oncology field but in all therapeutic areas.

We really are just seeing the tip of the iceberg when it comes to the introduction of tools and digital solutions to help trials sites find the best (and most diverse) patient populations and to help patients identify appropriate clinical studies. The end result will be better drugs that provide better outcomes.

Originally published on PharmasAlmanac.com on March 8, 2023.

Clinical trials for cell and gene therapies present a unique set of challenges, beginning with patient identification and recruitment and continuing on through implementation and long-term follow-up. Optimized solutions require CROs with extensive experience in managing complex trials — more specifically, in supporting cell and gene therapy, rare diseases, and the design and deployment of decentralized trials (DCTs).

Facilitating Recruitment in Distinct Patient Populations

Currently, most cell and gene therapies target rare diseases. Consequently, recruitment for these trials can be challenging, considering that the targeted patient population can be sparse and widely distributed across the globe. Decentralized trial models can enable this type of research by eliminating the need for patients to travel long distances to participate. Gene and gene-modified cell therapies can also present challenges relating to the concerns patients may have regarding new therapies. As a result, it is critical to develop a patient recruitment engine that leverages patient advocacy groups and key opinion leaders to build awareness of these new modalities and drive recruitment, as well as to build multiple modes of communication into studies.

A key component of this engine is education about the gene therapies themselves and the long-term implications comparable to hematopoietic stem cell transplantation. The decision to participate is a significant one, because once a patient has received a gene therapy treatment, they can no longer participate in any other clinical trials or receive any other gene therapy products. As a result, the decision to participate is often one that is made by the patient and their entire family or network of loved ones. There is a heavy responsibility on study teams and clinicians to ensure that the educational package is appropriately detailed and offered not just to the patient, but to others invested in their care.

Gene and gene-modified cell therapies are overwhelmingly based on viral delivery, so there is also a need to determine if the patient already has antibodies against the virus capsid used to deliver the therapy. The most efficient way to perform this type of screening is in a completely decentralized manner that brings the study to the patients, but it must be done carefully given the implications of the results. After analyzing these samples, patients who are shown to have antibodies to the vector under study may not be eligible to receive the particular treatment involved in the given study. However, immune responses against vectors and transgene products remain a hurdle to uniform efficacy. A better understanding of these immune responses will lead to improved vector designs and more targeted immune modulations. This holds potential to expand gene therapy to a wider set of human conditions. For instance, steroid drugs are currently widely employed in systemic, hepatic, and ocular AAV gene therapy to counter inflammation and antiviral T cell responses. Lessons from CAR-T cell therapy, where physicians learned to prevent cytokine release syndrome by inclusion of monoclonal antibodies in the immune modulation regimen to counter IL-6 signaling, may be helpful in that management of immunotoxicities in viral vector gene therapy.

Whether other members of the patient’s household have the same disease is another factor affecting eligibility for trial participation for therapies based on viral vectors. There is a potential for viral shedding after the patient’s gene therapy treatment. If this occurs, then people in the household with the disease who have not been treated could potentially develop antibodies against the viral vector, in turn, rendering them ineligible for treatment in the future. Here again, only blood draws are needed to screen for viral shedding, so the test can be performed in a remote setting outside of the investigator site. 

One of the ways to reduce that burden is to bring the study to the participant using a flexible protocol that incorporates elements such as eConsent, home-health nurses, televisits, and electronic patient-reported outcomes (ePROs) within decentralized trial designs.

Expanding Research to Common Diseases

Concurrently with digital advances in the industry, we are seeing an increasing number of candidates intended to treat more common diseases in today’s clinics. These patients generally have greater access to various existing therapies and may thus be resistant to treatments that cause modification of their DNA. Once again, education to create awareness and ensure that patients are equipped with necessary insights to make decisions around participation in cell and gene therapy clinical trials is paramount.

It will be equally important to manage patient expectation in terms of the potential impacts of these treatments over the longer term. One-time administration of a therapy that may be corrective for a particular abnormality or defect could mean less time in the hospital, reduced need for conventional treatments, and a better quality of life.

Collecting Consent Electronically

Participation in gene and cell therapy clinical trials is a big decision that can be life-changing but also carries real risk. Consent must therefore take place in the presence of the patient’s physician and in some cases a geneticist to ensure that the patient — who in many cases is a child — and the parents and/or caregivers can really understand what involvement in the clinical trial entails and to ensure that everyone has the opportunity to ask questions. 

There is a heavy ethical requirement for completing this process, because it is such a significant step. However, the COVID-19 pandemic has presented challenges to traditional methods — including meeting in person for these types of conversations and transactions. As a result, telemedicine has become a much more widely accepted option, as has remote electronic consent (eConsent). PPD Digital has developed tailored eConsent solutions designed to provide the necessary environment for this process, including access to the people and resources needed to help patients fully understand the myriad ramifications of the decision to participate in a clinical trial.  

Bringing the Study to the Patient

One of the greatest patient burdens associated with clinical trials is having to travel to the investigator site more often than would be required for their normal standard of care. One of the ways to reduce that burden is to align the protocol to the standard of care as much as possible. The other is to bring the study to the participant using a flexible protocol that incorporates decentralized (DCT) strategies, such as eConsent, home-health nurses, televisits, and electronic patient-reported outcomes (ePROs) within decentralized trial designs.

An extension of PPD’s DCT strategies is the dedicated patient concierge service, which facilitates travel where the need arises for patients to travel to different countries in order to receive a particular gene therapy. Our patient concierge option is the ultimate white glove service for reducing the burden of patients traveling to foreign countries.

Addressing Unique Logistics Needs: Immediate and Long-Term

Advanced therapies are complex, particularly autologous, personalized approaches. Very specific cells are being modified with very precise viral vehicles to get genes or constructs into cells. For personalized therapies, there is also a higher degree of CMC and manufacturing management, logistics, and communication requirements, and thus the integrity of the trial’s ecosystem and interaction of stakeholders is crucial.

These therapies take a multidisciplined approach to address needs for tissue/cell procurement and collection, including sample delivery at low temperature in limited timeframes, manipulation within a manufacturing process (which can take 4–12 weeks), preparation of the patient before treatment with the drug product, and ultimately monitoring of the clinical effect during post-reinfusion/recovery and over the long term. 

Within those steps, we need to consider whether the patient will be in a clinic, doctor’s office, or hospital or at home. Many different laboratories are also involved — to onboard the patient, analyze the therapeutic material, and monitor the safety and health of the patient during treatment and follow-up — each with its own regulatory compliance requirements. 

The chain of custody for the samples going to labs is also vital to the trial’s final data and endpoint analysis. The different samples, demographic information, and results must all be tracked and tied back to the correct patient — not just during the treatment period, but for up to 15 years afterward. During this time, some patient information may change, regulations will likely evolve, different testing requirements could be introduced, different laboratories might be used, and the sponsor or the product may be acquired by another firm with a totally different strategy. 

The very high level of communication and coordination required to achieve successful cell and gene therapy trials over the long term can only be achieved today because of technological innovations that have occurred in recent years. PPD can monitor every step of the process and ensure the necessary level of oversight. Technological innovation is particularly helpful as sponsors expand to broader patient populations and larger clinical trials. Having access to advanced digital databases and technologies provides answers and options that enable more efficiency in the process. 

It is particularly important during the long-term follow-up period to keep the patient experience in mind and identify solutions that optimize efficiency and effectiveness of data collection. Study teams must carefully consider the necessary level of connection with the patient, the site, and the physician and how burden can be minimized for everyone involved. Patient safety is always our top priority.

Simplifying Long-Term Follow-up Requirements for Patients

Clinical trial participation for cell and gene therapies, as mentioned above, does not simply end following the treatment. There is generally a follow-up period as part of the treatment protocol that involves frequent visits and more intense assessments to assess the safety and efficacy of the therapy. Patients then move into the long-term follow-up period, which can last 5–10 or more years, depending on the therapy and duration of follow-up in the treatment protocol. Many cell and gene therapies can also have post-authorization safety study (PASS) requirements that are similar to the long-term follow-up included in the clinical development process, but not all patients who receive these therapies post-commercialization must participate.

These long-term studies are conducted to assess safety and long-term durability of gene and gene-modified cell therapies. Gene therapy products are intended to achieve a prolonged or permanent therapeutic effect, but they may also result in undesirable or unpredictable adverse outcomes. Genetic modification of cells therefore carries risk, and it is essential to understand those risks in terms of well-defined outputs, such as secondary malignancies, impairment of gene function, autoimmune-like reactions, and latent and persistent infections. It is critical to ensure that the necessary vigilance systems are in place to continue collecting the required safety data. 

It is particularly important during the long-term follow-up period to keep the patient experience in mind and identify solutions that optimize efficiency and effectiveness of data collection. Study teams must carefully consider the necessary level of connection with the patient, the site, and the physician and how burden can be minimized for everyone involved. Patient safety is always our top priority.

Application of digital technologies, approaches, and experiences for data collection are other notable elements to consider. For instance, detailed case histories, including records of exposures and the emergence of new medical conditions of interest, that need to be established during the initial three- to five-year follow-up period can largely be collected using new electronic and remote modes of communication. 

The subsequent long-term follow-up can be set up as a fully decentralized process, which would include consistent, ongoing contact via telephone or questionnaires on a recurring basis to maintain the patient connection. Home health nurse visits and telemedicine can be employed, along with eConsent, ePROs, and other digital options to meet the needs of timely endpoint collection. Ultimately, the key is to leverage modern decentralized technologies to better retain connectivity with the patient while minimizing burden. This will also define how optimized AAV gene therapy dosing strategies are determined.

Additionally, many gene therapies are intended to treat rare diseases that occur in children. This means, if a five-year-old receives the treatment, at the end of the 15-year treatment and follow-up period, he or she would be a grown adult at 20 years old. As children grow and mature, priorities shift in terms of what is important to them and the best ways to engage with them. At the outset of the trial, they are highly dependent on their parents, whereas by the end of the period, they may be living on their own. Parent and caregiver needs evolve as well. It is also possible that the same parent or caregiver will not be involved over the entire course of the follow-up. For children, especially, it is therefore important to consider their journey as trial participants and instill a sense of continuity and consistency. One way to do this is by designing a protocol that allows for flexibility in technology, devices, geographies, and modes of communication throughout the years of research.

Comprehensive Solution Backed by Years of Experience 

PPD’s leading pediatric, rare disease, and cell and gene therapy centers of excellence are a direct example of how our teams have been invested the field of cell and gene therapies for over a decade. Our innovative spirit demonstrates we are not entrenched in a certain way of doing things, but instead constantly explore new ways to improve efficiency and effectiveness — decentralized solutions have always been a part of that. Working closely with PPD Digital, PPD’s decentralized clinical trials business unit, our teams offer an unrivaled solution to support remote cell and gene therapy trials. Active engagement with the scientific and medical communities allows us to stay abreast of technology and compliance.

With our integrated approach, PPD has the necessary functions working collectively across the organization to ensure the end-to-end clinical paradigm is covered. Within this enterprise spectrum of capabilities, PPD provides the essential agility and personalization of solutions needed to succeed. As a result, we are able to develop bespoke solutions for each client and trial that allow optimal connectivity with the patient and continuous data collection both within and outside of standard care. Whether a virtual startup or widely recognized global biopharmaceutical and biotech organization, we contribute value across the board — ultimately helping our customer’s cell and gene pipeline excel in today’s environment. 

As we move into a new era of clinical research, PPD recognizes the growing complexities that organizations face around long-term follow-up in the cell and gene therapy ecosystem and how modern technologies are taking form to fit the needs of those patients. We are committed to staying at the cutting edge through our partnerships with companies and sponsors developing these highly innovative, novel therapies that ultimately change the lives of patients.

Originally published on PharmasAlmanac.com on April 9, 2021.

Ergomed is a full-service clinical contract research organization (CRO) dedicated to providing specialized services to the pharmaceutical industry in support of drug development. With a legacy built on co-development and a commitment to scientific excellence, Ergomed leverages its expansive North American and European footprint to offer tailored, patient-centric solutions specialized in oncology and rare disease clinical research. Underpinned by a highly qualified team, the company thrives on a unique focus on patients, investigators, and sites while pursuing innovations that promise to reshape the future of clinical trials. In this Q&A, Dave Selkirk, President of Ergomed Clinical Research delves into the company’s specialized approach, the nuances of conducting global clinical research, and further clinical transformations on the horizon, in conversation with Pharma’s Almanac Editor in Chief David Alvaro, Ph.D.

David Alvaro (DA): To begin, can you share a general overview of Ergomed?

Dave Selkirk (DS): At its core, Ergomed is a CRO partnering with pharmaceutical and biotech companies to manage the clinical development phase of their programs, from the initial stages through post-marketing research.

As a midsize, full-service CRO, we’ve carved out a niche primarily in oncology and rare disease research, working extensively across North America and Europe. We have a comprehensive grasp of these territories, including the full gamut of Western, Central, and Eastern European regions. We are also significantly expanding into East and South Asia.

What sets us apart is our scientifically driven approach — across the Ergomed Group we have 110 MDs, plus another 542 employees with graduate degrees, bringing a wealth of knowledge to the table. This scientific prowess underpins our advisory role to our clients, ensuring that their projects are poised for success. This advisory aspect is ingrained in our ethos, drawing on a rich co-development history where Ergomed had shared investments and, inherently, successes with our partners. While we’ve moved away from the economic side of the co-development model, that commitment to our clients’ outcomes remains a guiding principle at Ergomed.

DA: Can you walk us through Ergomed’s history, from its founding through any other significant milestones that have shaped the company’s operations?

DS: Ergomed has a rich history stretching back more than 25 years. Our founder, Dr. Miroslav Reljanovic, is a neurologist and former principal investigator in clinical trials. He instilled a philosophy in Ergomed that remains central to our identity: a focus on the needs of the sites, investigators, and patients. This approach differentiates us within the CRO industry.

Dr. Reljanovic’s expertise in neurology laid the foundation for our strength in rare neurological diseases. Over the years, strategic acquisitions have bolstered this expertise. Notably, the acquisition of PSR Group BV in the Netherlands solidified our position in rare disease research, and the purchase of MedSource in North America expanded our reach and presence in oncology. These acquisitions, and Dr. Reljanovic’s vision, have been pivotal in enhancing our specialized services in these areas.

In addition to our CRO activities, we also launched PrimeVigilance in 2008, a division focusing on pharmacovigilance. This division has grown to be recognized for its expertise in a broad range of drug safety services including benefit-risk management, safety systems and reporting, medical information services, literature surveillance, pharmacoepidemiology, among others. It is another example of how Ergomed has evolved and adapted over time, continually improving and expanding its service offerings within the pharmaceutical and healthcare industry.

DA: How does that legacy of co-development continue to influence Ergomed’s approach to clinical trials?

DS: Our co-development heritage, where we once invested in and became part owners of the drugs we helped bring to market, has ingrained in us a deep understanding of the perspectives of our biotech partners. We understand the critical importance of adhering to timelines, designing protocols that align with care standards, and collecting outcomes data that will stand up to both regulatory and payor scrutiny, or be valuable in the case of a product sale or out-licensing.

We also appreciate the significance of major milestones within a study. For example, the “first-patient-in” milestone signals to the world that the trial conduct is underway, and it’s vital for biotech companies seeking venture capital, as it provides opportunities for press releases, the dissemination of information, and conference presentations. This insight into the unique pressures and expectations of biotech firms is embedded in our culture.

Our approach is consultative — we’re inquisitive by nature, and we make it our mission to thoroughly understand our clients’ objectives. This enables us to customize our services to fit their specific needs. We’re not here to just execute tasks; we strive to be strategic partners who add value by engaging actively and asking the right questions. It’s this collaborative ethos that sets us apart and defines us as a CRO.

DA: Could you discuss the impact of digitalization and decentralization on the clinical trials that Ergomed supports?

DS: The pandemic accelerated the shift toward decentralized clinical trials, democratizing participation across the gamut of demographics by potentially allowing anyone with internet access to participate. This shift has broadened the epidemiologic diversity of trials, which historically skewed toward certain socio-economic groups. Now, we can reach a much wider population.

The extent and value of decentralization varies across therapeutic areas. There is not a binary choice between traditional in-person and virtual trial models.  Instead, the key is to find the right balance between the two in a hybrid model. Certain aspects of clinical trials, particularly in oncology and rare diseases, still often require some components of in-person interactions, due to technological and diagnostic necessities, like in-depth imaging or treatments that require specialized training, expertise, or complex administration protocols.

Conversely, many patient-reported outcomes and simpler assessments can now be captured digitally. Patients can self-administer tests like blood pinpricks or provide urine and fecal samples from home.  More complex tests might only need a home visit from a healthcare professional rather than requiring the patient to travel to the clinic.

At Ergomed, given our focus on complex areas like oncology and rare diseases, we advocate for a balanced hybrid approach. We work closely with sponsors to design trials that blend essential in-person assessments at clinical sites or hubs with more straightforward, remote follow-ups. This model maintains efficiency, regulatory compliance, and a focus on both the patient and investigator experiences. With our background in co-development, we fully understand the importance of designing trials that meet regulatory requirements while also being efficient and considerate of the patients’ needs.

DA: Has the hybrid model of clinical trials been particularly beneficial in the context of oncology and rare diseases with geographically dispersed patients?

DS: The extremely low prevalence of certain rare diseases presents unique challenges for clinical trials. Patients afflicted with certain orphan indications may be clustered in specific ethnic groups or regions, while others are broadly dispersed around the globe.  These divergent scenarios make site selection and patient travel logistically challenging. This is especially true for patients with genetic diseases prevalent within isolated populations.

In these scenarios, applying a hybrid model to clinical trials is essential. We must carefully design trials to minimize patient travel — ideally, the patient should only need to travel to a site for the most complex assessments requiring advanced technologies and/or clinician skill. The rest of the trial activities, wherever possible, are conducted remotely through digital platforms such as real-time data exchange tools, wearables, videos calls, text messaging, etc. Wherever possible, it is also vital to incorporate off-site or in-home data collection by qualified healthcare professionals.  This approach not only makes participation feasible for these patients but also respects their time and unique circumstances, making the study design as inclusive and accessible as possible.

The hybrid (decentralized/in-person) model of clinical trials is also highly applicable and beneficial to oncology patients. In this large and broad therapeutic area, treatment therapies can be invasive, cytotoxic, and/or have side effect profiles that are challenging for patients and their caregivers.  Incorporating at least some components of the trial into a decentralized structure can eliminate significant burden from the patients’ care journey.  Improving their quality of life is an extremely powerful way to improve their clinical trial experience, and therefore to increase their level of engagement/participation.

DA: Could you elaborate on the three focus areas of patient-centricity, investigator centricity, and data-driven trial intelligence within Ergomed?

DS: At Ergomed, we’ve structured a dedicated Strategic Solutions and Patient Centricity group that concentrates on three key axes: patients, investigators, and data. Each axis is spearheaded by a director: we have a Patient Engagement Director, a Clinician Engagement Director, and a Data Intelligence Director, each an expert in their domain.

The Patient Engagement Director works closely with patient advocacy groups, which are especially crucial for successful rare disease studies. This person’s job is to understand the patients’ experiences and their journey through the healthcare system, which can be very complex in both oncology and rare disease.  This knowledge is used to inform protocol design and logistics and raise trial awareness in the patient community through the channels established by these groups. This role is pivotal in ensuring that the trials we design are patient-friendly and that participating in the trial doesn’t diminish the patients’ quality of life. It’s about empathy and logistics; understanding that participation hinges on minimizing the burden posed by the trial, empathizing with the patient and their support system/caregivers, and respecting the patient’s perspective.

The Clinician Engagement Director’s role mirrors that of the Patient Engagement Director but focusing instead on the clinicians’ viewpoints. It’s about grasping the clinicians’ perspective when treating these complex disease states, their interactions with other healthcare professionals, and their treatment challenges. This insight ensures the clinical trials are appealing to investigators and aligns as much as possible with their standard of care practices, making it more likely that they will want to participate and recommend the trial to their patients as a viable treatment option. These peer-to-peer interactions can also help identify barriers to care access for patients that need to be considered in designing a strategy for successful study execution.

Lastly, the Data Intelligence Director taps into various data sources, both public resources like GlobalData, Citeline, CT.gov, etc. and more specialized ones like PubMed, peer-reviewed journals, etc. to understand the epidemiology and logistics involved in trial planning. This individual analyzes the distribution of disease and the prevalence of diagnostic tests, offering crucial insights into the number of trial sites needed to execute the study and the aggressive yet achievable time required to recruit patients. It’s a comprehensive approach that ensures we’re not only initiating trials but also adapting them as they progress, staying informed through real-time feedback from both patients and clinicians.

DA: Can you expand on the support Ergomed offers for site management and how this role has evolved, especially considering the main concerns and needs of sites?

DS: Ergomed recognizes the increasingly complex demands placed on clinical trial sites, especially with the documentation and administration tasks that have grown since the COVID-19 pandemic. Distinct from our Clinical Research Associates (CRAs) who focus on ensuring protocol compliance, patient safety, and patient data integrity, our Site Management group focuses on supporting the Study Coordinator role at the investigator site. The Site Management team can assist from a distance, or also physically go on-site, managing logistics, mapping procedures, and handling the administrative and planning aspects of trials.

Our Site Management team stands out by offering bespoke support, not by offering only pre-packaged solutions but by listening to Study Coordinators, assessing their needs, and customizing a plan to support them efficiently. This might include ensuring that they have the necessary supplies, managing patient calendars, assisting with data entry, recommending protocol/industry best practices, or aiding with documentation and invoicing processes.

The Study Physician team is an additional level of site support offered by Ergomed, with this service being primarily directed to the Principal and/or Sub-Investigator.  Just as the Site Management group is distinct from the CRA role, so too the Study Physician team is distinct from the Medical Monitor role.  As has been established throughout the CRO industry, Medical Monitors focus on patient safety data ensuring the validity of medical assessments and searching for trends/signals. By contrast, Ergomed’s unique Study Physicians provide a peer-level medical and scientific consultation layer for the site’s medical doctors who treat the trial patients with the investigational therapy. This unique structure allows us to address scientific and medical challenges beyond safety data, underpinning profound protocol understanding, and fostering discussions that enhance patient recruitment and trial success.

This comprehensive, responsive support system of both Site Management and Study Physicians targets the specific needs of both Coordinators and Investigators and differentiates Ergomed from traditional CROs.

DA: How important is Ergomed’s large geographic footprint in helping sponsors to understand the regulatory and cultural nuances across Europe and the United States for their global trials?

DS: Our expansive reach across Europe and North America is a considerable strength. Our presence across these regions’ diverse ethnic landscapes mean we have cultivated a deep understanding of a broad array of regulatory environments, along with cultural norms. Our Patient and Clinician Engagement Directors conduct outreach in numerous languages and across different regions, ensuring that we gather region-specific insights.

This extensive network allows us to not just assume a universal response from doctors or patients based on data from one country, but to actively seek and incorporate feedback from multiple regions to tailor our trial plans. This comprehensive approach is invaluable, particularly for global trials where such nuances can significantly impact the success and relevance of the research. Having this large footprint enables us to operate efficiently and sensitively on a global scale, leveraging the best countries and regions based upon therapeutic standards of care recruitment potential and start-up timelines.

DA: What do you see as the primary differences companies face in implementing clinical trials in the United States versus Europe?

DS: While the European Medicines Agency (EMA) governs most European countries and the Food and Drug Administration (FDA) oversees the USA, their regulatory principles and good clinical practices are generally well aligned, despite some differences in wording and nuances.

However, the timelines for clinical trial approvals can vary significantly. In the United States, the use of central ethics committees allows for a quicker IND (Investigational New Drug) approval process, generally enabling faster trial initiation compared with the European Union.

Culturally, North America has a more receptive attitude toward decentralized clinical trials and home healthcare, a sentiment that’s gradually being embraced in Western Europe and also more commonly under consideration in Central and Eastern Europe. Technological advancements and increasing exposure from progressive sponsors and CROs are fostering greater acceptance of hybrid and decentralized trials in these regions.

This process is dynamic, and as technology becomes more integrated into everyday life, even regions that have historically been less receptive are beginning to adapt.  We’re seeing a trend toward a more unified global approach to clinical trials, influenced by both regulatory and cultural shifts.

DA: Can you tell us more about the Ergomed team, particularly some of the key individuals and their contributions to the organization?

DS: Ergomed’s strength is significantly derived from its people. Key figures in our team include Dr. Juliet Moritz, our Senior Vice President of Strategic Solutions and Patient Centricity, who, along with her team, embodies the co-development mindset, offering crucial insights to our sponsor partners in oncology and rare disease.

Natalia Grassis, our Executive Vice President of Global Operations, oversees the entire global operational spectrum of our clinical trials. She ensures that each trial is well-staffed, resourced, and equipped, playing a critical role in Ergomed’s successful partnerships and trial outcomes.

Dr. Colin Hayward, our Head of Medical Science and a seasoned professional in oncology as well as rare disease, advises clients on protocol design and regulatory matters, contributing to the depth of our understanding of biotech sponsors’ priorities.

Lastly, Dr. Nikola Strumberger, our Senior Vice President of Business Development (a Medical Doctor himself) has an extensive global network throughout the pharma and biotech industry.  His medical background brings invaluable expertise when engaging with active and prospective sponsors alike.

Together, these individuals and the entire Ergomed team ensure that our operations are executed with expertise, innovation, and a deep commitment to advancing clinical research to address unmet medical need.

DA: What trends do you predict will transform clinical research in the near future?

DS: I see several transformative trends on the horizon for clinical research. First, there has been an increasing acknowledgment of breakthrough therapies in North America and Europe, with regulatory systems in place to fast-track their approval. This acceleration allows vital treatments to reach patients sooner, often with the requirement for post-marketing commitments to gather long-term safety data. As a result, we might see a rise in post-marketing research demands, shifting these studies from voluntary branding exercises to rigorous, regulatory-mandated programs.

Decentralized clinical trials are another trend set to continue evolving as technology advances. With innovations such as mobile health applications and wearables, more assessments that previously required in-person clinic visits may shift to digital and point-of-care scenarios. Even medical assessments currently requiring skilled technique, invasive and/or large volume sample collection, or even large and complex equipment, are likely to become increasingly self-administered via advancements in technology and mobility.  These evolutions broaden the epidemiologic diversity of clinical trial populations and augment the relevance of the findings to the full global population.

Additionally, the concept of synthetic control arms is emerging as an exciting development. Instead of traditional control arms with active or placebo comparators, synthetic control arms utilize real-world data from patients receiving standard care. This method, facilitated by electronic medical records, claims data, disease registries and historical clinical trial data, could revolutionize control groups in clinical trials by reducing costs and logistical burdens. While this approach is still in its infancy, the potential for this methodology is significant, and we anticipate that it will play a larger role in years to come. Ergomed is poised to embrace these changes, ensuring that our clinical research methodologies remain at the forefront of innovation.

DA: Are there other ways that you envision technology enabling clinical research to evolve beyond current approaches?

DS: Technology is poised to revolutionize clinical research in ways we’ve only begun to explore. One intriguing prospect is the ever-advancing technology that allows increasing comprehensive results from decreasing small samples of blood.  If self-phlebotomy (i.e., pin prick for blood spot collection) can yield an adequate blood volume for a broad array of assessments, new possibilities for frequent, event-triggered data collection will become feasible like never before.

Wearables are already a part of this transformation, moving us away from the traditional, discrete timepoint model of data collection. Many of us already wear devices that monitor a wide range of physiological data in real time.  Imagine a future with a wearable device collecting data to a degree of scientific rigor that would permit the data to be included in a clinical trial, and ultimately a regulatory or payor submission. This could offer us a detailed picture of what’s happening before, during, and after a clinical event, giving us insights into potential triggers and the effects of different activities or states, such as exercise or sleep, on the patient’s health.

While the scope of data currently collected by wearables is somewhat limited, the potential for growth is immense. As these devices become capable of capturing more in-depth and varied health metrics, we can use artificial intelligence (AI) to sift through this vast amount of data to identify trends and signals that were previously undetectable.

Both sponsors and patients are beginning to embrace the potential of wearables, but we’re still at the tip of the iceberg in terms of what’s possible. With AI’s evolving capacity to process vast amounts of data, the future of clinical research could see a significant shift toward a more dynamic, real-time understanding of patient health and disease progression. This approach not only enhances our understanding but could also lead to more personalized and timely interventions.

DA: How do you foresee Ergomed growing and changing over the next few years as the sector evolves?

DS: Ergomed’s commitment to specialization remains unwavering. We’re dedicated to sustaining our high level of medical science expertise, particularly in the fields of oncology and rare disease. These areas are not only extensive but also highly complex, often intertwining with neurological and genetic factors. We consciously choose not to dilute our focus by trying to be a generalist CRO that covers all therapeutic areas; instead, our strength lies in our deep understanding of our specialized fields. We are seeing increasing numbers of sponsors in the USA, Asia, and Europe interacting with us because of our scientific expertise.  It is the ‘rocket fuel’ that drives our strong growth in both the near and long-term.

In line with this commitment to specialization, we aim to grow further as a significant midsize player in the CRO industry, including geographical expansion as part of our growth strategy.  While we have a robust presence in North America and Europe, we’re growing our direct operational presence in both East and South Asian countries. We’ve laid the groundwork with existing offices in Japan and India and intend to further our local Asian presence in the vital country of China.

Our goal is to build upon our existing strong foundations — our knowledge of investigators, care standards, and patient populations — to cement our position as a therapeutically specialized yet geographically expansive CRO. This expansion is aligned with our overall mission to enhance our global impact while staying true to our areas of expertise in oncology and rare disease.

Originally published on PharmasAlmanac.com on May 30, 2024