Clinical Strategy
With the right clinical strategy, you gain certainty about what to expect during the clinical evaluation
The right preparation for your clinical evaluation
Planning security and clarity about what needs to be done
We create your Clinical Evaluation Plan (CEP) so that you know exactly what to expect. This allows you to arrange any additional required pre-clinical tests, clinical studies, or clinical investigations at an early stage and plan the resources needed.
Regulatory safety
With a well-founded clinical strategy, you can be sure that you are complying with all relevant requirements, e.g., MEDDEV 2.7/1, during the development of your medical device.
Less clinical investigations
Clinical investigations can disrupt schedules and budgets. Our experts can help you determine whether a clinical investigation is necessary before market approval.
Early risk minimization for smooth product approval
Developing a clinical strategy is essential for the successful market launch of a medical device. However, in many cases, this fails due to inadequate planning:
Suddenly, for example, a clinical investigation is necessary after all, and the costs cannot be borne, or critical advertising statements (claims) are made contrary to the intended purpose, which, in the worst case, costs you approval.
With a sound clinical strategy, you can avoid such pitfalls.
We accompany you methodically to your optimal clinical strategy
Our clinical affairs team will help you to develop a tailor-made clinical strategy. Together with you, we proceed as follows:
Determining the state of the art and deriving clinically relevant endpoints (parameters) for the safety and performance of the medical device
Definition of acceptance criteria and verification methods
Formulation of the medical benefit
Optimization of intended purpose, indication, and contraindication based on existing clinical data
Checking the consistency of statements, e.g., in the areas of claims, IFU & intended purpose, and checking advertising claims for critical characteristics
Evaluation of the current data situation and checking whether pre-clinical tests or a clinical investigation are necessary
Planning suitable study activities before and after market approval (clinical investigation, PMCF studies)
Creation of the Clinical Evaluation Plan (CEP)
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