The Benefits of Fractional CROs for Early-Stage MedTech Startups
Early-stage MedTech startups take on an enormous challenge in bringing their product to market, especially if regulatory bodies require clinical trials for market access. Trials often require significant time and money. While traditional contract research organizations (CROs) are a common solution, for a young MedTech startup or a company with limited resources or time, a traditional CRO may be out of reach or impractical. A fractional CRO is an alternative solution that is cost-effective, quick, and doesn’t sacrifice quality. Utilizing fractional CROs, companies have access to the necessary expertise, while avoiding the cost and timelines commonly seen with a traditional CRO. ActiVie, a fractional CRO, specializes in supporting early-stage MedTech startups with cost-effective and flexible solutions.
What is a Fractional CRO?
A fractional CRO, like ActiVie, embeds themselves as fractional teammates into Sponsor organizations. They provides expert clinical research services on a project or part-time (fractional) basis. Fractional CROs allow for custom support for each stage of clinical development, tailoring each solution to each customer. Benefits of partnering with a fractional CRO include:
Cost savings: A fractional CRO provides expert support at a fraction of the price because the project teams are smaller and made of only necessary experts, no administrative staff contributing to overhead. This allows coveted resources to be reallocated elsewhere.
Flexibility: Operationally, a traditional CRO typically leverages a large team and can be bogged down by cumbersome processes and procedures, making adjustments difficult. Fractional CROs implement smaller project teams, including only the experts necessary for each project phase and allowing for agile project management.
Custom solutions: Traditional CROs may require all trials they support to use certain processes or procedures, potentially missing key data or bloating processes for startup trials. Fractional CROs are tightly integrated with Sponsor teams, creating custom solutions and implementing everything you need and nothing you don’t.
Partnership in Practice: How a Fractional CRO Saved a Trial
Selecting a partner to implement a clinical trial is critical and can be overwhelming. Choosing the wrong partner can be costly, risk trial failure, and significantly impact company milestones or time-to-market. ActiVie recently partnered with an early-stage MedTech startup to save a first-in-human trial that had gone off schedule and budget. Specifically, they:
Audited and reviewed all data and documents: The eTMF was found to be 75% empty so ActiVie worked closely with site staff and in-country partners to complete within 3 months. The EDC was found to have never been reviewed by Data Management so new data review plans were developed and data reviewed immediately.
Created new CRFs and systems: Original CRFs did not capture all required data per protocol. New CRFs were created and shared with the sites in 2 weeks. New EDC, CTMS, and eTMF systems were built from scratch in 3 months, including a migration of all old data.
Migrated and cleaned all old data: All previously collected data were mapped to the new CRFs, imported, and reviewed by data management, reducing site burden. ActiVie created and closed more than 1200 queries as part of data migration and review.
ActiVie did all this in 5 months (including all migration, review, and transfer of ownership) and at about 40% of the cost of the original CRO, ultimately allowing the Sponsor to utilize the data in subsequent FDA submissions and conferences, and to take the trial in-house, resulting in substantial savings and increase in transparency and control of the trial.
Conclusion
While it may seem like a daunting, almost impossible, task for early-stage MedTech startups to run a clinical trial, fractional CROs like ActiVie can help. It's important to pick a partner that will grow with you and support a fast time-to-market. Fractional CROs are cost effective, flexible and bring a team of clinical research experts with a tailored solution. Without taking on full-time staff, startups can execute rigorous and compliant trials, ultimately raising the chances of success.
