Clinical and Medical Affairs strategy consulting for medical device companies.

01

Clinical evidence strategy

Clinical evidence strategy is the architecture of the program: what must be shown, in whom, and in what sequence. Intended use, the proposed indications, and a protocol written for clinical practice — not rebuilt after it reaches a CRO.

• Clinical evidence strategy planning

  Map intended use against the evidence that exists. Name the gaps for FDA, notified bodies, and treating physicians. Sequence feasibility, IDE, pivotal, and PMCF against what the company can fund.

• Protocol design and synopses

  Structure the core trial: objectives, entry criteria, target population, visit schedule, and procedure burden. Short enough to socialize. Specific enough to write from.

• Endpoint selection

  Primary, secondary, and exploratory outcomes that regulators will accept and that the specialty will believe.

• Control-group strategy

  Evaluate sham, active comparator, and standard-of-care arms for necessity, ethics, and what labeling will require.

• Trial design

  Feasibility through pivotal — designed for approval, time, and the clinic.

02

Regulatory and strategic roadmapping

The clinical plan and the regulatory plan should be written together. We build the target product profile, the milestone meetings, and the regions in scope. We do not replace regulatory counsel.

• Target product profile

  Define intended use, labeling claims, safety and effectiveness thresholds, and the evidence required to support them — and say which claims the device cannot support yet.

• Agency briefing

  Strategy and materials for milestone meetings: FDA Pre-Sub / Q-Sub, IDE, PMA or De Novo discussions, and the equivalent conversations in other regions.

• Global harmonization

  Align trial design with FDA, EMA, PMDA, and NMPA requirements so a single program can travel.

• Indication prioritization

  Evaluate therapeutic targets for the fastest credible path to market, based on evidence, competitive landscape, and development feasibility.

• Clinical evaluation

  Clinical evaluation reports and evidence summaries to the standard EU MDR and related frameworks actually read, tied to the claims the company intends to make.

• Submission support

  Clinical content for FDA, EMA, and related submissions — the modules that must be accurate and complete.

03

Site and CRO selection and oversight

Trials fail at the site, not in the statistical analysis plan. We assess which investigators can enroll against volume and the procedure as it is actually done, then help select and manage the CRO. Complementary to a CRO, not a substitute.

• Site feasibility and investigator strategy

  Geographic prevalence, local standard of care, site capacity, and the competitive trial landscape — before sites are contracted.

• Enrollment modeling

  Recruitment timelines given inclusion and exclusion, procedure burden, and the sites that will actually enroll.

• CRO selection and management

  Help select and oversee the CRO so the protocol they execute is already thought through.

• Vendor selection

  Core lab, imaging, ePRO, and other execution partners — scoped to the protocol, not stacked on after.

• Decentralized trial strategy

  Where remote follow-up, wearables, and home nursing reduce patient and site burden without weakening the endpoint.

04

Biostatistics and payer evidence

Statistics and payer evidence belong in the protocol, not after first enrollment. Sample size, the statistical analysis plan, adaptive design, and payer evidence strategy are provided through exclusive partnerships. Regenesis Scientific Strategy leads the analysis of trial data so the clinical team can act while the study is still running.

• Sample size

  Power calculations to enroll the minimum required for statistical validity.

• Statistical analysis plan

  Data methodologies and early stopping rules a data monitoring committee can use.

• Adaptive design

  Sample-size re-estimation, interim analyses, and stopping rules based on accumulating data.

• Payer evidence strategy

  The endpoints, patient-reported outcomes, and follow-up payers will require, specified in the protocol.

• Trial data analytics and insights

  Interim and study data reviewed for operational and clinical insight — enrollment, outcomes, and what the protocol should change while the trial is still running.

05

Medical Affairs

Device companies often hire commercial teams before they have a medical narrative treating physicians will stand behind. We build the Medical Affairs function a medical device company needs, and operate it until a permanent hire can take it over.

• Fractional Medical Affairs

  Stand up and run the function: scientific narrative, processes, and the first operating cycles, then transition to a hire.

• KOL engagement

  Map thought leaders by clinical volume and influence. Advisory boards with a defined job. Relationships that can survive a labeling conversation.

• Medical information

  Inquiry response, off-label handling, and standard response letters written to the claim the evidence supports.

• Medical review of claims

  Review of scientific and promotional claims against evidence and labeling.

• Investigator-initiated studies

  Coordinate and govern IIS so independent research strengthens the evidence plan instead of scattering it.

06

Scientific communications

We write and direct the scientific record so the claim in the journal and at congress is the same sentence.

• Medical writing

  Peer-reviewed manuscripts, congress abstracts, slide decks, and clinical study reports — claims matched to data, limitation sections included.

• Publication planning

  A dissemination sequence tied to data locks, congress calendars, and authorship consistent with specialty standards.

• Congress and scientific meetings

  Abstracts, posters, and symposium content grounded in the clinical evidence.