Clinical strategy is the function that determines whether your development programme will produce the evidence you need to reach approval, market access, and value demonstration – in the right sequence, within a timeline and budget that can be defended to your board.

Most development failures are not scientific failures. They are strategic failures: endpoints that were scientifically valid but not accepted by regulators without additional data, Phase II studies that produced encouraging results but could not support a Phase III sample size, trials that enrolled on time but generated data that payer bodies could not use for formulary decisions.

Clinical strategy at APICES is built by teams who have experienced these failure modes and who bring that operational history into the design process. We do not design studies in abstraction. We design studies in the context of what regulators will accept, what sites can actually deliver, and what payer bodies will find credible.

What Clinical Strategy Covers at APICES

• Target product profile (TPP) development and gap analysis against regulatory and access requirements
• Clinical development plan (CDP) for single-asset or portfolio development programmes
• Protocol synopsis and full protocol authoring, including eligibility criteria, endpoint definition, and statistical considerations
• Endpoint and biomarker strategy, including surrogate endpoint justification and translational planning
• Regulatory strategy: EMA scientific advice preparation, FDA Type B and Type C meeting briefing documents, and integration of authority feedback into the final protocol
• Payer alignment: HTA-relevant endpoint design, health economic assumptions, and evidence gap assessment for AMNOG, HAS, NICE, and other national bodies
• Medical device development: MDR Annex XIV clinical evaluation planning, ISO 14155 study design, and IVDR clinical performance study design

Integration with Feasibility and Execution

The most consequential aspect of clinical strategy at APICES is its connection to feasibility and operational planning. A protocol that looks scientifically sound on paper can be operationally undeliverable – because the target population is rare, because the inclusion criteria are too restrictive for European sites, or because the comparator arm requires a standard of care that is not uniform across the intended countries.

At APICES, feasibility input is built into the design process from the earliest phase. Before a protocol is finalised, the country and site feasibility team reviews the eligibility criteria, endpoint requirements, and country strategy against current operational data. Where design choices create operational risk, alternatives are identified and trade-offs are documented so the sponsor can make an informed decision.

EMA Scientific Advice and FDA Pre-IND / Type B Interactions

Regulatory authority interactions – EMA Scientific Advice, FDA Type B meetings, MHRA scientific advice, and national competent authority consultations – are high-stakes decision points in clinical development. APICES prepares regulatory interaction packages from within the clinical and regulatory team, not as an outside consulting exercise.

Briefing documents are written by the same team that designed the study, reviewed by the same medical and statistical leads who will execute it, and integrated into the development plan within the same operational structure. EMA scientific advice outcomes and FDA written responses are then reviewed systematically: each regulatory comment is classified by impact on study design, endpoints, and statistical approach.

What You Can Expect

• A TPP and CDP aligned with regulatory, access, and operational reality
• Full protocol authoring with integrated feasibility review before criteria are locked
• Regulatory interaction support: EMA and FDA briefing documents, meeting preparation, and response integration
• Endpoint strategy that serves both regulatory approval and HTA/payer access requirements
• Continuity from strategy through execution: the same senior team stays on the study
• Medical device clinical development strategy under MDR and ISO 14155

Frequently Asked Questions

What does APICES include in clinical strategy and study design?

Target product profile (TPP), clinical development plan, protocol synopsis and full protocol authoring, endpoint and statistical strategy, biomarker and translational planning, and EMA scientific-advice preparation when relevant.

Do you support EMA scientific advice and FDA Type B / Type C interactions?

Yes. We prepare briefing documents, support sponsor representation, and integrate the regulatory feedback into the final protocol design and statistical analysis plan.

Can APICES adapt strategy for biotech, pharma, and medtech sponsors?

Yes. For biotech we focus on Phase I–II oncology speed and EU site selection; for pharma we focus on payer-grade endpoints and HEOR alignment; for medtech we align with MDR Annex XIV and ISO 14155.

When in development should I engage APICES on strategy?

Earlier is better – typically pre-IND or post-IND but pre-protocol-finalisation. We also take on rescue strategy work for trials that have hit feasibility or recruitment problems mid-study.

How does APICES connect strategy to execution?

The same senior team that designs the strategy stays on the study through delivery. There is no hand-off to a separate operations team.