Early-stage MedTech startups take on an enormous challenge if bringing their product to market requires clinical trials. Trials for regulatory approval often require significant resources and money. While traditional contract research organizations (CROs) are a common solution, for a young MedTech startup, a traditional CRO may be out of reach. A fractional CRO is an alternative solution that is cost-effective, quick, and doesn’t sacrifice quality. Utilizing fractional CROs, early-stage startups 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, provides expert services in the clinical research industry 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 and cost savings.
- 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, a fractional CRO, 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. The EDC was found to be never reviewed by Data Management so new data review plans were developed.
- Created new CRFs and systems: All new CRFs were created compliant with regulations and the protocol and shared with the sites in a matter of weeks. A new EDC, CTMS, and eTMF were built from scratch and shared with the Sponsor ensuring transparency and compliance.
- Migrated and cleaned all old data: All previously collected data were mapped to the new CRFs, imported, and reviewed by data management, resulting in more than 1200 queries reviewed and resolved by ActiVie.
ActiVie did all this in 5 months 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. 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.