What is Clinical Evidence Strategy?
Clinical Evidence Strategy is a high level plan of proposed data collection activities, pre- and/or post-market, aligned with commercial goals/stakeholder needs.
It is the foundation of successful market access. Whether you are preparing for CE marking, FDA clearance, or planning your post-market activities, a clear, proportionate and commercially aligned evidence plan is critical.
Our Clinical Evidence Strategy service helps you define what evidence is needed, why it is needed, and how it should be generated to support your regulatory and commercial objectives.
Who is it for?
Product development team and whoever is responsible for go-to-market strategy.
Why it matters?
• Avoids cost of having to do additional studies to meet needs of stakeholders beyond regulators.
• Aligns clinical data collection to product claims.
• Ensures outcome measures are aligned with clinical evaluation.
It is in compliance with ISO14155 – Clinical investigation of medical devices for human subjects – Good clinical practice.
Typical phases and process overview:
• Discovery & Gap Analysis – Review product, regulatory history, intended use, device risk, commercial goals.
• State of the Art review and alignment with regulatory strategy
• Evidence Generation Strategy (EGS) Development – Map options for clinical data generation (methods, markets, timelines).
• Alignment on EGS – decision on best path with cross-functional alignment.
• Execution plan – Next level of detail mapped out to enable client to move into execution mode. Specifics will vary depending on nature of activities in the EGS.
Pre-market clinical investigation planning (CE mark + FDA)
We help you decide whether a clinical investigation is needed, and if so, how to design it so it supports both approval and commercial claims.Post-market evidence planning for PMCF requirements (PMCF + FDA post-market expectations)
Post-market evidence is where a lot of value can be added through low cost methods of data collection, targeted evidence to support key claims and potential for label expansion, whilst also meeting the requirements for PMCF.Real world evidence planning
Real-world evidence can be a major advantage, if it’s designed properly. We help you plan how to generate and use RWE in a way that supports:-regulatory decision-making
-label expansion and future claims
-market access conversations (value, outcomes, cost effectiveness)
We work with you early, ideally at prototype stage, to ensure your intended use, claims, and development pathway are aligned with the evidence burden required in your target markets. A well-designed strategy prevents costly redesigns, reduces delays, and avoids over- or under-scoping clinical investigations.
We deliver a structured, actionable plan that integrates regulatory requirements, risk profile, and commercial ambition.
Our expertise includes:
- Pre-market clinical investigation planning to support CE marking (EU MDR) and FDA submissions
- Post-market clinical follow-up and evidence planning in line with EU MDR and FDA expectations.
- Real-world evidence strategy, including registries, retrospective analyses, surveys, and large dataset utilisation.
- Evidence gap analysis and justification strategies.
- Alignment of intended use, claims, and evidence generation.
Under EU MDR and evolving FDA expectations, clinical evidence is a continuous lifecycle requirement. Regulators expect manufacturers to justify not only the quantity of evidence, but also its relevance and methodological rigour.
At the same time, commercial teams need claims that differentiate, without creating an unsustainable evidence burden.
By embedding clinical strategy within your broader commercialisation plan, we ensure your evidence pathway supports both regulatory approval and market adoption.
Frequently Asked Questions
When should a company bring in expertise in clinical strategy?
Ideally the development of the clinical strategy would start in early product development (prototyping stage) to ensure that there is alignment with intended use and what is achievable from an evidence perspective. If an intended use is very broad then that sets up a very high evidence burden whilst if it is too narrow the commercial prospects are limited so having an understanding of the evidence required helps hit the sweet spot.
What's the difference between pre-market and post-market evidence planning?
Pre-market evidence generation has to be done in a certain way because access to the product is restricted to those involved in clinical studies. Therefore, there are a lot of controls around how the study is conducted, with close monitoring of adverse events. Post-market has a wider range of potential methods for developing evidence. This could be a study very similar to a pre-market study, or it could be a survey of users, a retrospective analysis of patient medical records, a registry which captures data from all patients or an analysis of large data sets such as insurance databases. It all depends on the product and the reason why particular evidence is needed.
What information will clients need to provide?
To start the conversation clients will need to share the nature of the device, it’s intended purpose, regulatory classification in target markets (if known), which key markets they plan to sell into, and where the product will be used and any other insights they have as to how the product will fit into existing clinical pathways. A clinical strategy is developed in the context of the whole commercialisation plan so it is beneficial to share as much information as possible as discussions progress.
We won’t keep you waiting
We respond to all enquiries within minutes of receiving them.
Our lead times match the urgency and demand in the market – we offer industry-leading turnaround times because we know how critical reliable data is for your project. While what you’ve seen is our typical lead time, the final timeline will depend on your specific study requirements. But rest assured, we’ll do everything we can to deliver even faster.
Think of it like a relay race – we’ll hand over the data baton as quickly as possible, so you can keep moving forward on your medical device journey.
