The TMF is the official record of the clinical study for Regulatory Authorities, be it…
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.
As all players today explore how best to adapt to the new demands of a dynamic clinical trial landscape solutions with superior vendor teaming capability are rising to the forefront. With the critical priority of reliable, easy access to an outsourced team of experts, mid-size and smaller biopharma study sponsors have come to recognize that larger CROs are often unable to effectively deliver this for their smaller biopharma clients.
The significant dynamics of business operations between the larger and smaller, niche CROs, for studies by mid-size and smaller biotechs in critical indications such as oncology, neurological disorders, or orphan drugs a smaller, often means the best choice involves multiple niche CROs and vendor teams specialized by region.
The reason being that 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, in an effort 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 the mid-size or smaller study sponsor has access to anyone else on their project.
Superior Vendor Teaming Capability Formed from Lessons Learned
As an example, a niche Canadian Oncology CRO acting for mid-size and smaller size global North American Study Sponsors in collaboration with Canada’s Oncology Research Centers, Scimega is uniquely positioned with an effective option that eliminates the risk and worry for these sponsors of developing their own a multi-vendor model in the region.
With its proven track record bundled with 25 years of lessons learned Scimega offers a Multi Niche Web™ of specialized experts who work together seamlessly for each sponsor’s study success in Canada by devising innovative solutions to address the unique challenges of each sponsor’s oncology clinical trial, by bringing together the right combination of specialized expertise.
A Multi Niche Web™ of specialized experts work in tandem with Scimega: to seamlessly integrate the trial study plan; bring key mitigating actions and solutions throughout the study; without any added administrative or logistic burden to the mid-size and smaller biotech’s team members.
Identify the Right Team to Connect with Sites & Meet All Milestones: Recommended Actions
- 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, so engage vendors with strong, long-standing site relationships in your study regions.
Above All Build Partnerships
The key to efficient vendor teaming is moving out of a transactional relationship and into a strategic relationship model. The first step in this process is to respect all vendors as valuable partners with the aim to work collaboratively as a team.
The most effective niche CRO, understands and streamlines each vendor internal process. Who does what? When? Who is in contact with whom and when? When and how should an issue be escalated? This will allow a good understanding of all the steps taken during a specific process, and take action at the appropriate level in the first place. It is also important for all to know who is the main contact for any particular aspect of a project, to prevent delays in getting responses, and avoid nonproductive back and forth emails. A good example of this in practice is to keep your vendors posted on any site personnel change, as it helps ensure emails/queries get to the right contact in the first place for speedy resolution.
How to Build & Validate Your Extended Team of Multiple Niche CROs and Vendors Specialized by Region
- Interview CRAs/PMs, and other vendor team members 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.
Choosing the Right Partners
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 acquiring 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.
In every instance Scimega works with your team to devise innovative solutions to address your unique challenges, bringing together the right combination of specialized expertise for your cutting-edge oncology trial.
Whatever the unique requirements of your oncology clinical trial, with its proven track record bundled with 25 years of lessons learned Scimega offers an effective Multi Niche Web™ of specialized experts who work together seamlessly for your study success.
If you’re interested in learning more about the Canadian opportunity, explore an expansion with us!
Contributed by: Julie Martin, CEO & co-Owner