Study planning/ preparation
Whether for clinical trials with medicinal products of all phases (phase I-IV) or clinical trials of medical devices, we are happy to support you in planning and operational management tasks.
From concept development and submission to authorities over layout, printing, distribution of study documents to remuneration management and publications: You will receive a complete service package.
- Consultation on selection of study design
- Statistical aspects in planning of studies, sample size calculation, randomisation
- Preparation of study protocol/clinical investigation plan and additional documents (patient information leaflet, informed consent form, patient diary, etc.)
- Development of Case Report Forms (CRFs – paper or EDC)
- Submission to Ethics Committee and Competent Authority
- Site selection and feasibility check
- Import notifications/Import licences for medicinal products
- Trial Master File
- Risk analysis und development of a monitoring strategy
- Training of investigators and study nurses
- Organisation of investigator meetings
- Close cooperation with stduy sites (in- & outpatient), central laboratories & external experts
- Management of contractual agreements