Clinical research and development
Standard services
- Investigator’s brochure
- Investigational Medicinal Product Dossier (IMPD)
- Clinical trial design (e.g. synopsis, concept sheet)
- Non-interventional study/registry design (e.g. observational concept)
- Document preparation
- Clinical trial protocol
- Observational plan
- Patient information and informed consent form
- CRF set-up input and review
- Submission package compilation
- Assessment of GCP conformity
- GCP teaching for investigators and clinical trial staff
- Statistical analysis plan input and review
- Statistical report review and interpretation
- Medical data review and plausibility check
- Medical aspects of risk-based quality management
- Medical surveillance and monitoring
- Clinical study report preparation
- Result presentation
- Stakeholder and public summary and presentation
- Lay-person summary
- Safety narratives
- Publication strategy proposal
- Publication writing and submission coordination
What qualifies me?
- More than 20 years of active involvement in set-up and conduct of clinical and non-interventional studies
- Hands-on experience as clinical project manager