On Site Management
Planning of all logistical aspects at the study centre
We help you with an overall logistical planning and a careful preparation and follow-up of patient and monitoring visits to ensure that your research project runs as smoothly as possible.
Review of study documents regarding feasibility (including budget)
We check the feasibility of the planned visits (schedule) and give you a realistic estimate of the associated costs.
Preparation of study-specific documents (logs)
We help you to keep track of your studies with obligatory, study-specific documents (logs).
Creating and maintaining Investigator Site Files (ISF)
We create the Investigator Site File (ISF) for you as an investigator in accordance with the applicable regulations and maintain it for the entire duration of the study. We support you in the subsequent professional and prescribed archiving of the documents.
Screening and inclusion of study participants
We accompany screening, clarification and inclusion of study participants and conduct study-specific training.
Planning of study visits
We organise study visits and ensure that your patients are booked on time.
Preparation and administration of samples/biobanks
We take care of the protocol-compliant acceptance, further processing and storage or dispatch of study specific samples.
Medication/device Management (unblinding, drug/device accountability)
We ensure on-time delivery, the prescribed storage and preparation of your study medication. We take over the drug accountability and, at the end of the study, the organization of the proper destruction of residual stock. To this end, we work closely with the hospital pharmacy.