We support you by:
- Ensuring prompt delivery of high quality CSR.
- Identifying a list of necessary documents to provide to Medical Writers thus helping them in preparing well-structured and well-written.
- document, which supports your clinical development program, regulatory submission process, and ultimately drug labelling.
- Preparation of ‘fit for purpose’ document which fulfils reporting requirements and facilitate FDA, EMEA and local regulatory review.
- Clear identification of all members of the team confirming their roles, responsibilities and commitment to making their contribution to the CSR.
- Presenting clinical study results within CSR according to the context of your current drug development program.
- Interaction with the project team to provide a wider strategic understanding of the product and obtain key insights into specific aspects of the CSR such as statistical and pharmacokinetic interpretation.