Feature
Write the protocol before you hire the CRO.
Most device programs lose months — and a round of amendments — because the clinical plan is still being invented after the CRO is under contract. The evidence plan should be done before execution starts.
A Clinical Evidence Strategy Plan names intended use, the claims the device can support, and the gaps FDA, a notified body, and treating physicians will ask about. From that plan comes a protocol synopsis short enough to share with the team and detailed enough to write a full protocol from.
When that work is complete before CRO engagement, the sponsor selects a CRO to run a protocol that already exists. Amendments drop. Site burden is known. Complementary to a CRO: the protocol is complete going in, so execution is smaller, clearer, and cheaper.
Protocol complete before CRO engagement: fewer amendments, a timeline that holds, and a cost the board can defend.
From the desk
What a 15-minute fit call is for
Stephanie Washburn, PhD, takes a short first call. The question is whether the program has a defined Clinical or Medical Affairs need — evidence plan, IDE or pivotal design, clinical evaluation, fractional Medical Affairs, or a publication sequence — and whether Regenesis Scientific Strategy is the right fit.
Selected work
Class III craniofacial neuromodulation — resistant chronic migraine
Late-breaking abstract and poster accepted at a major medical meeting.
Class II closed-loop wearable — phantom limb syndrome
Clinical Evidence Strategy Plan with an FDA-ready Clinical Investigational Plan synopsis for Pre-Sub.
Class II transcutaneous spinal cord stimulation — spinal cord injury
Audit-ready Clinical Evaluation Plan and Clinical Evaluation Report on file for the Notified Body.
Note
Payer evidence belongs in the protocol
Reimbursement strategy specified after first enrollment is a common and expensive error. The endpoints, patient-reported outcomes, and follow-up a payer will require can be written into the protocol before sites are contracted.