Clinical and Medical Affairs · Medical Devices
Clinical and Medical Affairs for Medical Devices.
Regenesis Scientific Strategy provides specialized Clinical and Medical Affairs strategy, complementary to a CRO. Engagements run from first evidence plan through commercial launch.
30 years
Scientific strategy — from research through regulatory labeling.
20 years
Medical-device Clinical and Medical Affairs.
Class I–III
Device programs across the risk spectrum.
50+ trials
30+ sponsors
First-in-human to post-market.
01Work
Recent engagements
Class III
Late-breaking abstract and poster for a Class III craniofacial neuromodulation system in resistant chronic migraine
Accepted late-breaking abstract and poster at a major medical meeting
Class II
Clinical evidence strategy plan for a Class II closed-loop wearable in phantom limb syndrome
Completed CESP, including an FDA-ready CIP synopsis for Pre-Sub
Class II
Clinical evaluation update for a Class II transcutaneous spinal cord stimulation system in spinal cord injury
Audit-ready CEP and CER on file for the Notified Body
02How we work
Strategy before, during, and after the CRO.
Specialized Clinical and Medical Affairs strategy is in place before the CRO is engaged, during study execution, and after the study closes. The protocol is complete before CRO engagement so the study requires fewer amendments and a more efficient timeline and cost. We help select and oversee the CRO during execution, and we continue Medical Affairs and scientific communications through commercial launch. This is complementary to a CRO — not a substitute, and not an expensive addition.
01
Scope
A 15- to 30-minute call to assess fit. A longer conversation follows to define the need, then a written proposal. Scope can be adjusted until both sides agree on a final scope of work.
02
Strategy
Clinical and Medical Affairs strategy before, during, and after the CRO. We do not execute large multicenter trials. When a CRO or other vendor is needed, we help select and oversee them.
03
Fees
The fee structure is set to the company and the project. Engagements may be fractional, project-based, or hourly when that is the better fit. Fees are agreed in writing before work begins.
03Services
Six areas of Clinical and Medical Affairs work.
Clinical evidence strategy
The evidence plan and protocol — intended use, endpoints, and a study clinical sites can actually execute.
Regulatory and strategic roadmapping
Target product profile, agency meetings, and indication sequence — so clinical work is aimed at intended use and labeling.
Site and CRO selection and oversight
Which sites can enroll, which CRO should execute the study, and how the protocol will hold up in clinic.
Biostatistics and payer evidence
Sample size, statistical analysis plans, adaptive design, and payer evidence strategy are provided through exclusive partnerships. Regenesis Scientific Strategy leads trial data analytics and insights on live studies.
Medical Affairs
A Medical Affairs function before commercial launch — KOL engagement, medical information, and investigator-initiated studies.
Scientific communications
Manuscripts, publication plans, and congress content — written to the standard the specialty actually reads.
The work
Clinical and Medical Affairs strategy from first evidence plan through commercial launch, with CRO selection and oversight before, during, and after the study.
Start a conversation
If you need Clinical and Medical Affairs strategy, write.
A 15- to 30-minute call is enough to assess fit. No deck required.