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.
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
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