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Today, we are joined by a guest who carries a wealth of experience spanning 25 years in the healthcare and life science sectors. Jason Shuris, the Chief Business Officer at Innovaderm, has held senior leadership roles in specialized Contract Research Organizations (CRO). His journey is a testament to his unique blend of business acumen and deep industry knowledge. Let’s dive into the significance of selecting a niche CRO with Jason.
We will be exploring 3 crucial points in our discussion:
- Scientific and Therapeutic Area knowledge that “generalist” CROs cannot match
- Strategic Trial Expertise in Niche Areas
- Expertise in Disease-Related Endpoints
Unique opportunities and advantages niche CROs have over generalist CROs
The unique opportunities and advantages that niche CROs have over generalist CROs can be likened to the mastery achieved by individuals who focus on honing one or two skills. Just as a musician who specializes in playing the guitar or drums may perform in their field, so too can a CRO that concentrates on a specific therapeutic area.
In the crowded market of CROs, both in North America and globally, there are niche CROs that specialize in certain therapeutic areas, and generalist CROs that attempt to cover a broad spectrum. The latter often face the challenge of trying to be everything to everyone, a goal that is virtually impossible to achieve.
One of the significant advantages of niche CROs is their ability to excel in their chosen focus areas. They are not distracted by external factors and do not have to learn new areas on the fly, a common challenge for many generalist CROs. For example, if a generalist CRO is bidding on a project in Women’s Health without much experience in that area, they may struggle to execute the trials efficiently and professionally, despite their best research efforts.
In contrast, niche CROs, with their focused expertise, can add significant value by executing trials with a high level of proficiency and efficiency. This focus allows them to truly master their chosen therapeutic areas.
Strategic Trial Expertise
The primary advantage of working with a niche CRO lies in the unique value they add in various ways. They bring a scientific perspective to the study design, understand the patient population, and know how to recruit effectively. They also comprehend the physician’s experience in a clinical trial, which is crucial.
Unlike generalist CROs, niche CROs have a deeper insight into the workings of each research site, the protocol, the disease area, and the patient journey. They understand the benefits to the patients and can add significant value upfront.
On the execution side, niche CROs have operations teams that specialize in one therapeutic area, enabling them to gain deep expertise. In contrast, a project manager at a generalist CRO might work on an ophthalmology study one year, a cardiology study the next, and an oncology study the following year. This lack of focus makes it challenging for them to succeed and add value to the program they support.
This principle extends to clinical monitors visiting the sites. It is difficult for a monitor who jumps from an oncology study to a dermatology study to ensure appropriate monitoring according to the protocol. It is also crucial for them to develop relationships with the doctors and staff at the sites. Niche CROs and their Clinical Research Associates (CRAs) often build lasting relationships with principal investigators (PIs), sub-investigators, and site staff, which benefits the program.
Data management is another area where niche CROs shine. They understand edit checks and know what inconsistencies to look for in the data. They can identify potential problems when expected correlations between variables do not occur.
In summary, a niche CRO can bring a wealth of benefits to a program, whereas generalist CROs may struggle to add the same level of value.
Strategies to ensure your team remains knowledgeable in this context
Companies focusing on one or two therapeutic areas can stay updated with the latest advancements in the field, endpoint development, and newly approved drugs by participating in large conferences and continuing education.
Niche CROs often invest significant time and effort into attending therapeutic-specific conferences. These events are not just for sales and business development; they also provide an opportunity for clinical scientists and operations personnel to learn about the latest developments in the field, interact with doctors, clinicians, and peers.
In addition to external learning opportunities, some niche CROs have robust internal training platforms. These platforms, part of their Standard Operating Procedure (SOP) matrix, provide ongoing training for all employees, from clinical scientists to front desk staff. The training covers a range of topics, including specific diseases, endpoints, approved drug classes for treating those diseases, and emerging mechanisms of action. This mandatory training ensures that all staff members retain knowledge and stay updated with the latest developments in the field.
Moreover, employees at niche CROs often have a personal passion for the therapeutic area they work in. They proactively read articles and newsletters in their own time to better understand the evolving landscape. In today’s information-rich age, it is easy for individuals to access a wealth of knowledge and continually improve their understanding of their field. This self-driven learning, combined with formal training and conference participation, equips niche CROs with a highly knowledgeable staff, providing a significant advantage in their specialized areas.
As we conclude another illuminating episode of Phase Forward, we find ourselves at the crossroads of science and progress. Remember that behind the jargon and statistics, lies stories of unwavering commitment, meticulous observation, and the pursuit of evidence that shapes our understanding of health and disease. Stay at the forefront of knowledge and innovation and follow Phase Forward on your preferred platform. My name is Valerie Coveney. Thank you for joining us. Until next time.
Let’s shape the future of research and make a difference in the industry, gain Innovaderm’s support in your upcoming trial and propel your study to new heights
