Efficient and reliable study management - from planning via implementation to a successful completion of clinical trials for pharmaceuticals and medical devices - is the key to your success. All necessary regulatory, statistical and considerations concerning data handling are taken into account in order to guarantee an optimal course of the study.

We offer our support in all phases (Phase I – IV) of your clinical trial.

Study preparation:

  • Consultation on selection of study design
  • Statistical aspects in planning of studies, sample size calculation, randomisation
  • Preparation of study protocol 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
  • Trial Master File
  • Creation of IMPDs (Investigational Medicinal Product Dossiers)
  • Training of investigators and study nurses
  • Organisation of investigator meetings
  • Close cooperation with phase I - IV sites (in- & outpatient), central laboratories & external experts

Study controlling and evaluation:

  • Monitoring / Co-Monitoring
  • Project management - only one contact person in charge of communication
  • Documentation and logistics assistance at the study centre, query management
  • Study supply management
  • Data entry, biometrical evaluation of data, coding (MedDRA, ATC, WHO, etc.)
  • Query management
  • SAE responsibility
  • Preparation of study reports according to ICH-GCP guidelines
  • Preparation of publication manuscripts
  • Quality Assurance (Audits)