Clinical and Medical Affairs strategy consulting for medical device companies.

01

Clinical evidence strategy

Clinical evidence strategy is the plan for the program: what must be shown, in which patients, and in what order. Intended use, proposed indications, and a protocol written for real clinical use — not rewritten 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 share with the team. Detailed enough to write a full protocol from.

• Endpoint selection

  Primary, secondary, and exploratory outcomes that regulators will accept and treating physicians will find credible.

• 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, timeline, and how the procedure is done in clinic.

• Preclinical studies

  Bench, animal, and GLP safety and performance work. This offering also serves pharma and biotech; other RSS work stays focused on medical devices.

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, working with the company's regulatory representative and exclusive partners.

• 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 one program can support more than one region.

• 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 written to EU MDR and related requirements, 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

Sponsor-side trial management

Do not give a trial to a CRO and step away. The company still needs experienced trial management of its own — someone who knows the regulations and represents the sponsor. That is how a study stays on track and on budget. We do that work. We identify sites. We run small studies. For larger studies we select and oversee a CRO, and we still manage the trial for the company. Complementary to a CRO.

• Sponsor-side clinical trial management

  An experienced clinical trial manager representing the company — not the CRO. Protocol adherence, vendors, budget, and timeline while the study runs.

• Site identification strategy

  Which investigators can enroll against volume and the procedure as it is actually done, before sites are contracted.

• Site feasibility and investigator strategy

  Geographic prevalence, local standard of care, site capacity, and the competitive trial landscape.

• Small-scale study execution

  Feasibility, FIH, pilot, and other small studies run by Regenesis Scientific Strategy when a full CRO is not the efficient path.

• CRO selection and management

  For larger studies, help select and oversee the CRO. The CRO runs the trial. We continue to manage it for the company.

• Vendor selection

  Core lab, imaging, ePRO, and other execution partners, selected to match the protocol.

• 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

Biostatistics belongs in the CESP, not after the protocol is locked. Statistical strategy is set up front. Sample size, the statistical analysis plan, adaptive design, and interim analysis are provided through exclusive partnership — before first enrollment, while the study runs, and after it closes. Regenesis Scientific Strategy leads the analysis of trial data so the clinical team can act while the trial is still running. Payer evidence strategy is a separate exclusive partnership.

• Statistical strategy

  The statistical questions in the CESP — endpoints, estimands, and what must be true before the protocol is locked. Up front, not after first enrollment.

• 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 story physicians can support. We build the Medical Affairs function a medical device company needs, and run it until a permanent hire can take over.

• Fractional Medical Affairs

  Build 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. Identify the right HCPs for CESP and protocol input, and include that input in the plan.

• 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 investigator-initiated studies so independent research supports the evidence plan instead of running as disconnected studies.

06

Scientific communications

We write and manage the scientific record so the claim in the journal matches the claim at the meeting.

• 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.

07

Strategic and fractional leadership

Lean device companies often need senior Clinical and Medical Affairs judgment before they have a department. We advise at the executive level, manage the program, set operational strategy, and help the organization take shape until a permanent leader is in place.

• Executive advisory

  Counsel to the CEO, CMO, or board on evidence, Medical Affairs, and how the clinical plan supports the next financing or filing.

• Program management

  A single owner for the clinical and medical workstreams so CESP, partners, and vendors stay on one plan.

• Operational strategy

  How the function will actually run: cadence, decision rights, and what belongs in-house versus with a CRO or partner.

• Organizational development

  Role design, hiring sequence, and transition so the company can take the function in-house when it is ready.

08

Fundraising strategy

Non-dilutive funding is part of the development plan. We write grants and related applications so the study described in the grant is the same study described in the evidence plan.

• Grant writing

  Applications written to the evidence plan, the protocol, and the budget the program can defend.

• Non-dilutive funding strategy

  Which mechanisms fit the stage of the device, and how the ask maps to Pre-Sub, feasibility, or pivotal work.