We tend to talk about studies in post-NDA and trials in pre-NDA.

The Interventional studies, also called Phase IV, come from medical affairs or marketing.
Subjected to the directive 2001/20 obligations, they have become less attractive, due to the cost inferred by the double authorisation [local agency, ethics committee] and other regulatory requirements.

However they are an indispensable tool for the knowledge of the product’s life in real prescription conditions, the exploration of new strategies, the support of the product launch, as well as the entire life of the drug.

They can either be traditional with a paper CRF, be in an electronic format (eCRF), or with a logistical platform. The important factor being that the appropriate questions are asked, not forgetting to inform the investigators and patients of the results …. and to publish them afterwards.

Come to see us so we can begin to discuss your synopsis, or ask us to brainstorm an idea.

We have a large and extensive background with these studies.

We can provide your contract specifications and estimates ASAP.