Study specific documents and submission for trial authorisation

In order to be able to perform a clinical trial, an application has to be submitted to ethical committees and in some countries also to local authorities. DADA can write and submit these applications on behalf of our customers.

In addition to giving advice on the best clinical strategy suitable for each situation, DADA can write the clinical trial protocols needed, as well as individual study specific documents such as investigators brochure, informed consent forms, etc. These documents comply with the rules and regulations in the European Union and are in accordance with Good Clinical Practice.

The Investigational Medicinal Product Dossier (IMPD) is one of several pieces of Investigational Medicinal Product (IMP) related data required whenever the performance of a clinical trial is intended in one or more European Union Member States. The IMPD includes summaries of information related to the quality, manufacture and control of any IMP (including reference product and placebo), and data from non-clinical and clinical studies. When applying for a clinical trial authorisation, a full IMPD is required when little or no information about an IMP has been previously submitted to competent authorities, when it is not possible to cross-refer to data submitted by another sponsor and/or when there is no MA in the Community. DADA experts can write the full IMPD as well as individual modules as needed.