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