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
Class I, II, and III device programs.
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
02Popular services
Three services companies ask for first.
01
Clinical evidence strategy planning
A Clinical Evidence Strategy Plan maps intended use and claims against the evidence that exists, names the gaps, and sequences the studies the program can fund. The CESP includes a trial synopsis written as an FDA-ready Clinical Investigational Plan for Pre-Sub, so the first FDA meeting is based on a written plan.
02
Scientific communications
Abstracts, posters, and manuscripts written for the journals and meetings the specialty uses. Late-breaking submissions, congress support, and publication planning so the publication matches the protocol.
03
Trial data analytics and insights
Interim and study data reviewed while the trial is still running — enrollment, outcomes, and programming — so the clinical team can act before the database locks. Complementary to the CRO’s statistical reporting.
Clients
What sponsors take away.
“We asked Regenesis Scientific Strategy to help us take the IDE study design to the American Headache Society Annual Scientific Meeting, the main scientific meeting for our migraine program. They worked closely with our key HCPs and internal teams, tightened the scientific communications strategy, and drafted the late-breaking abstract and poster. Late-breaking is a short window and a harder review than the regular program — and it was accepted.
In parallel, Regenesis partnered with us to analyze data and evaluate programming activities and clinical outcomes. Their work provided valuable insights that supported our programming approach for our IDE study. The result was a stronger scientific presence at AHS and a more informed perspective on our study data and clinical program.
That’s Clinical and Medical Affairs strategy, done well.”
“Stephanie helped us build out clinical function and managed the 36-patient study we ran in-house for Opioid Addiction. She took us from FDA Pre-Submission through a successful clearance. When I hear of a company needing clinical and medical affairs leadership, I send them to Regenesis Scientific Strategy.”
“Regenesis Scientific Strategy has been a valuable partner as we prepared for our FDA Pre-Sub. They helped align our team around the clinical evidence strategy, provided the framework and initial drafts for our Clinical Evidence Strategy Plan and CIP synopsis, and connected us with a variety of top-tier service providers including the biostatistical expertise needed to strengthen the study design.
Their experience helped us translate our clinical objectives into a clear, executable study plan and a well-structured package for FDA review.”
03How we work
Strategy before, during, and after the CRO.
Specialized Clinical and Medical Affairs strategy is in place before the CRO is engaged, while the study runs, and after it closes. The protocol is complete going into CRO engagement, which means fewer amendments and a more efficient timeline and cost. When a CRO is needed, we help select and oversee them. Medical Affairs and scientific communications continue through commercial launch. Complementary to a CRO.
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 work on the sponsor side. Small studies we can run. For larger studies we select and oversee a CRO, and we continue to manage the trial for the company.
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.
04Services
Clinical and Medical Affairs services.
Clinical evidence strategy
The evidence plan and protocol: intended use, endpoints, and a study sites can run.
Regulatory and strategic roadmapping
Target product profile, agency meetings, and indication sequence — so clinical work is aimed at intended use and labeling.
Sponsor-side trial management
Sponsor-side clinical trial management. Site identification strategy. Small studies we can execute; larger studies with a CRO — we still manage the trial for the company.
Biostatistics and payer evidence
Statistical strategy in the CESP; sample size, SAP, and adaptive design through exclusive partnership. Execution before, during, and after the trial. Regenesis Scientific Strategy leads trial data analytics 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 for the journals and meetings the specialty uses.
Strategic and fractional leadership
Executive advisory, program management, operational strategy, and organizational development — leadership support before you hire a full-time lead.
Fundraising strategy
Grant writing and non-dilutive funding, written to the CESP and the clinical plan.
In short
Clinical and Medical Affairs strategy from first evidence plan through commercial launch, with CRO selection and oversight before, during, and after the study.
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If you need Clinical and Medical Affairs strategy, get in touch.
A 15- to 30-minute call is enough to see whether we are a fit.