Study planning/preparation
Whether for clinical trials of medicinal products of all phases (I-IV), clinical trials of medical devices or other studies – we offer you comprehensive support for all planning and operational management tasks.
From concept development, submission to authorities, layout, printing, distribution of study documents to fee invoicing and publication: with our all-round support, you can concentrate fully on the success of your study.
What we offer
- 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
- Trial Master File
- Risk analysis and development of a monitoring strategy
- Training of investigators and study nurses
- Organisation of investigator meetings
- Close cooperation with study sites (in- & outpatient), central laboratories & external experts
- Management of contractual agreements