Clinical Affairs - CRO
From feasibility to regulatory approval

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:

  • Clarity and stability of the intended use and related desired claims
  • Availability of valid literature supporting part of the claims
  • Strength of the pre-clinical / animal testing

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

Preparing a CER

The difficult exercise of preparing a Clinical Evaluation Report (CER) usually starts in three different contexts:

  • Before a Clinical Investigation, in order to precisely evaluate the currently available clinical assets such as literature with the objective to correctly scope the investigation
  • After a Clinical Investigation, in order to build the appropriate evidence of fulfillment of the essential requirement related to clinical safety and efficacy, as part of a regulatory submission such as CE marking.
  • After a regulatory submission when the Notified Body or the FDA indicates that either the methodologic adherence to MEDDEV 2.7/1 Rev. 4 is not demonstrated or if part of the core data set is deemed insufficient.

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.