The TMF is the official record of the clinical study for Regulatory Authorities, be it…
Partnerships sometimes do not work out as intended. For medium size and smaller biotech companies enlisting the services of a third party with established standard operating procedures (SOPs), expertise, and technology, usually offsets risks and reduces the need to hire staff or purchase technology.
However, when a sponsor’s chosen CRO partner has sent their study too far off-track it’s important to make the right call and decide to bring in one or more new partners mid-stream. In such a recovery mission your incoming research vendor(s) must act quickly and efficiently to offset the chaos that can arise from poor quality deliverables, sub par KPIs of timelines not being met, numerous unanticipated change orders, and/or unrelenting staff turnover.
Choose the Right Size CRO
Any one of these issues could lead to data integrity issues or human subject protection concerns, causing a potential pitfall for the study overall if left unaddressed. Given this preeminent level of impact, it’s worth your time to consider whether or not the commonly held belief that using a larger CRO for your study is the best course of action.
In reality, and particularly for studies by mid-size and smaller biotechs in critical indications such as oncology, neurological disorders, or orphan drugs a smaller, niche CROs specialized by region may well be the better choice.
Key among the factors to take into consideration when opting to replace a CRO vendor, is not only therapeutic area, but the significant dynamics of business operations between the larger and smaller, niche CROs, and most specifically how such organizations assign employee numbers.
In oncology and other critical indications any assigned personnel may perform the same job, but sponsors are more likely to encounter errors and/or costly delays when non-therapeutically aligned employees are assigned and learning on the job, and at your expense.
Use the Right Team to Connect with Sites & Meet All Your Milestones:
- Engage an extended Team with robust oncology & clinical research experience
- Set low turnover as a critical success factor for engagement of your extended team
- Make a careful and critical examination for local, in-depth understanding and applied knowledge of known and ‘behind-the-scene’ site policies & particularities
- Never underestimate the Importance of Trust:
- In clinical research as everywhere, teams are made up of people, and people work most effectively for and with those they trust;
- Every PI relies on their trusted support staff to undertake their clinical research studies.
Mid-size and smaller biotech sponsors working with larger CROs spend significant time chasing after, trying to track down, and find out what is going on with different aspects of their study, trying to determine who is handling what. In short, micromanaging their large CRO partner. To get answers, the sponsor is supposed to talk to the CRO project manager. Not infrequently, the project manager (who often changes every 2-3 months) doesn’t have the answers, and it’s rare that the sponsor has access to anyone else on their project.
How to Build & Validate Your Extended Team:
- Interview CRAs/PMs when you outsource;
- Add ‘staff assignation approval’ in your agreements;
- Collect questions and feedback on the protocol/study set-up versus site policies/SOC, ask for a list of possible risks along with suggestions to avoid/mitigate them ahead of time;
- Have CRAs rehearse SIVs;
- Instate periodic Governance meetings with executive/directors from your vendors to ensure the bigger picture and milestones are on track.
The smaller, niche CRO that is well managed, with low turnover, and a clinical operations team populated with experts in oncology can provide a living archive for your program development over the long term. At Scimega the same project team follows a Sponsor’s program from Phase I to II, and subsequently heads any scale-up to Phase III that follows. Thereby providing not only the necessary therapeutic alignment of personnel, but also the accessible knowledge of what is and has gone on with a study program from its outset.
A recent example of the value of this living archive occurred when one of Scimega’s sponsors was acquired by a larger sponsor, and the entire clinical study team of the initial sponsor subsequently moved on. This left no one in the larger sponsor’s team for the clinical trial project with any experience with or knowledge of the history of the project. In such an instance, it was the smaller, niche CRO, Scimega, that was able to support the new sponsor’s newly assigned clinical project team, and provide the comprehensive history of the earlier study phases, and key aspects that had been lost in the sponsor’s personnel transition.
Choose the Right Region
For the mid-size and smaller biopharma company the stakes are always high for every trial conducted. With limited resources and pipelines, successful execution of a global trial is critical as outcomes may determine the future of the compound and possibly the ultimate survival of the company itself.
Participation by Canadians in oncology clinical trials is 14%. Nearly triple the 5% participation rate in the U.S. Projections to 2036 indicate people of color will make up about one third (31% to 36%) of the total Canadian population. A diverse population combined with a universal healthcare system for all Canadian citizens offers a compelling opportunity for cutting-edge U.S. biotechs striving to ensure global trials get the right mix of participants.
In Canada, cancer patients are funneled through select oncology health centers across the country and will typically receive treatment at the same center throughout the evolution of their disease (1st, 2nd line, 3rd line, etc). A factor that greatly aids in identification of possible oncology trial participants.
Canada currently ranks 5th among countries (excluding the U.S.) that contribute the greatest number of clinical trial participants globally. While the number of physicians per population has increased in Canada over the past decade, and is expected to continue to increase for the next several years.
Mobilizing an expert Canadian team with strong relationships with clinical sites significantly enhances study start-up and overall performance. The following real-world enrollment metrics features how Scimega’s unwavering strategic focus delivers on its commitment to Sponsor’s programs.
Choose the Right Partner
To transform an underperforming study into a productive one is possible under the right guidance. Enlisting the help of a monitoring CRO with a motivated CRA team of experts in their field, and experienced in site management can turn your trial around.
The Scimega team delivers consistent clinical trial start-up times 50% faster than the North American average, with trial sites often among top enrollers in global oncology studies. Scimega selected and motivated Canadian sites achieved an FPI surpassing its own 6-week KPI target in 2021, and over 90% of active sites enrolled participants.
To a great extent, the future success of an increasingly more complex clinical trials industry to bring new products to market rests on the ability of sponsors and CROs with their network of sties to work together ever more effectively. Whereby all parties benefit from strong partnership established on a meeting of goals and ‘minds’ to forge win-win-win outcomes for the sponsor, the CRO, and the sites and patients served.
Scimega is a Canadian niche oncology CRO that serves small to medium size biotech companies in clinical development of cutting-edge oncology therapies.
Contributed by: Julie Martin, CEO & co-Owner