CTU Bern (Clinical Trials Unit)

Clinical Investigation

The Clinical Investigation workflow is a service unit within the CTU Bern. It offers professional services to investigators working at Inselspital Bern or to other interested parties conducting single-center or multi-center clinical studies. Services include logistic support, planning, coordination and execution of clinical studies from phases I to IV, as well as assistance with observational studies.

We cooperate closely with individual departments of the Inselspital Bern, the pharmaceutical industry, and contract research organizations.

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Service

Ideally, our clinical investigation is involved early on in the planning of a clinical study. In any case successful work means that there is a close collaboration. The ideal clinical investigation workflow for a clinical study would lead through the steps graphically illustrated to the right. Services provided by the clinical investigation workflow include, but are not limited to, the following:

  • Supporting applications for ethical approval; e.g., correspondence with and submission of study protocols to the local ethics committees
  • Recruiting and instructing healthy volunteers and patients, including pre-screening (by appointment or via telephone) and checking eligibility criteria
  • Planning, organizing, coordinating and conducting participant study visits
  • Collecting and administering study data on paper and electronic case record forms (CRF), including resolving queries
  • Administering investigational medicinal products
  • Obtaining, processing and storing blood samples
  • Storing investigational medicinal products
  • Archiving study documents
  • Providing contact persons for study participants, principal investigator, sponsor or any other individuals involved in the clinical study
  • Providing points of contact for monitors and attending during monitoring visits and audits.
  • Evaluating and reporting adverse events in clinical studies according to CIOMS/WHO criteria

Our facilities

The Clinical Investigation workflow is situated at University Hospital Bern, Inselspital, in Personalhaus 2, Freiburgstrasse 44B, Entrance/Eingang 7. The map of the Inselspital shows us at coordinates C2.

Our facilities include:

  • Fully equipped treatment rooms, including monitoring units for inpatient studies
  • Rooms for outpatient study visits of patients and volunteers
  • Access to the certified laboratories of the Inselspital Bern, including chemistry, hematology, microbiology, therapeutic drug monitoring and other specialized investigations. Shipping to central study laboratories, if required
  • Rapid access to emergency treatment via our own life support equipment and the University Hospital’s 24 h emergency center and resuscitation team
  • Sample processing and controlled storage according to GCP guidelines (-20°C and -70°C)
  • Controlled storage and handling of study medication, according to GCP and study guidelines
  • Storage of study files (hardcopy and electronic data) for 15 years
  • Working facilities for visiting study monitors

Map