The setup of a sound Clinical Strategy is an essential step towards a predictable regulatory pathway.
At the stage of project initiation and product development, the identification of the actual need for a Clinical Investigation is a key. This crucial work requires at least the following aspects to be considered:
Medidee is your partner for exploring options and establishing a lean and clean strategy.
Once the need for a Clinical Investigation is confirmed, Medidee acts as CRO for the preparation and regulatory approval of the study, the monitoring and a successful conclusion. See link for details
The difficult exercise of preparing a Clinical Evaluation Report (CER) usually starts in three different contexts:
The support of Medidee may include full work packages with the delivery of a turnkey CER or may focus on a specific strategic coaching, or a review.
Medidee integrates a full scientific team ready to write your CER, including the difficult organization of literature search.
The key success criterion is the ability of the support team to capture the detailed design, regulatory and quality aspects specific to the product.