We can assist you with:
- Investigators Brochure. Including project management of team deliverables
- Protocol. Clinical pharmacology or interventional of any phase
- Subject/patient information. The Subject information has to be written according to ICH E6 guidelines, and be consistent with the protocol and the IB.
- Standard Operating Procedures, or other internal guidance document
- Review and/or quality check of all kinds of clinical documents, i.e. all documents included in e.g. CTA, IND, MAA, or NDA, RMP, annual regulatory updates, CDP, PIP, CSR