Clinical study related documents
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.
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.
DADA has monitored more than 100 complete BA/BE projects and has evaluated over hundred BA/BE study reports. For over 30 years, our experts have reviewed many more clinical study reports prepared by CRO’s all over the world. Comments and recommendations given by DADA clinical and regulatory affairs experts have been found particularly helpful in case of “old” dossiers that required resubmission for regulatory review (e.g. for new applicants or additional countries).
DADA has substantial experience in writing full study reports of several types of clinical trials for both human and veterinary products; pharmacokinetic studies, bioequivalence studies, efficacy studies etc. We can write a study report from core study documents, as well as build on an already existing draft. All study reports written by DADA are based on and compliant to the ICH E3 guidance.