History

Funding proposal The proposal to fund CTU Bern is submitted to the Swiss National Science Foundation (Main applicant: Peter Jüni from the Institute of Social and Preventive Medicine; additional applicants: Hans-Peter Marti (nephrology), Iris Baumgartner (angiology), Heinrich Mattle (neurology), Stephan Windecker (cardiology)).

The Swiss National Science Foundation approves the proposal and provides seed funding, initially for the first three years (CHF Mio 1.05). CTU Bern is one of three units that receives funding in the first round of the program.

CTU Bern is formally founded and hosted at the Institute of Social and Preventive Medicine of the University of Bern (its first offices are located at Niesenweg 9). Peter Jüni acts as its director. The unit is initially staffed with three persons: an associate director, a projector manager, and an administrative assistant.

The first two years are characterized by establishing the basic infrastructure (basic accounting system, electronic data capture system) and marketing activities to publicize the new unit within the university hospital (Inselspital Bern, Universitäre Psychiatrische Dienste Bern, Zahnmedizinische Kliniken) and the university.

The first course with 25 participants on Good Clinical Practice and Research Ethics is held by CTU Bern (basic level).

The first advanced Good Clinical Practice and Research Ethics course is held by CTU Bern (19 participants).

CTU Bern is heavily involved in the largest project of the Spezialprogramm Universitäre Medizin of the Swiss National Science Foundation: Inflammation and acute coronary syndrome (ACS) - novel strategies for prevention and clinical management. A large and long running cohort study originates from this project and the first international trial supported by CTU Bern.

Because of renovation work, CTU Bern temporarily moves offices to UniS to finally arrive at the basement of Finkenhubelweg 11 at the end of the year. These offices (plus rooms on the third floor) will be the home of the unit for eight years.

An interim report is submitted to the Swiss National Science Foundation with a request for funding for an additional two years (CHF Mio 0.4). This proposal is approved by the Swiss National Science Foundation.

Institutional quality management and quality assurance of clinical studies are spotted as major areas for development. Consequently, a quality manager is hired, and the number of defined processes/standard operating procedures grows rapidly.

The first professional on-site monitor is hired

CTU Bern is inspected by Swissmedic. The inspection reveals some deficiencies in quality management. It becomes clear that a clinical trial unit requires a professional quality management system.

The former Clinical Investigation Unit of Inselspital Bern becomes an orphan after the head of the unit retires. To this end, the unit is integrated into CTU Bern as a workflow (as divisions of CTU Bern were called at that time).

Originally established as an independent unit of the Direktion Lehre & Forschung of Inselspital Bern, CTU Bern is integrated into the Department of Clinical Research (now called Department of Biomedical Research) of the University of Bern to ensure sustainability.

A comprehensive quality management system is implemented with the help of an external consultant.

A project management system including an electronic billing system is realized.

Staff of CTU Bern has been growing to 42 persons with 20.2 fulltime equivalents.

TU Bern is inspected by Swissmedic with a focus on the Clinical Investigation Unit.

CTU Bern holds several educational events to prepare researchers for the enactment of the new Swiss Human Research Act. The first event is held at the Auditorium Ettore Rossi with more than 100 participants.

The Swiss Human Research Act becomes effective. This new law has a major impact on how clinical research is regulated in Switzerland and consequently also on all processes at CTU Bern.

Peter Jüni becomes the new director of the Berner Institut für Hausarztmedizin and resigns as Director of CTU Bern. Sven Trelle and Urs Fischer (neurology) become Co-Directors of CTU Bern.

The Swiss National Science Foundation launches its Investigator Initiated Clinical Trials (IICT) program. This program will become an important funding opportunity for CTU Bern.

Consulting for clinical researchers, especially from Inselspital Bern, is a major service by CTU Bern. In 2015, 222 consultations are done by CTU staff. At the same time, 273 projects are open and running.

GCP Refresher courses are offered for the first time. They rapidly become very popular. The 500th participant is welcomed in a basic GCP course of CTU Bern.

The Swiss National Science Foundation approves three projects with direct CTU Bern involvement within its first call of the new Investigator Initiated Clinical Trials (IICT) program.

CTU Bern establishes a monthly lecture series (CTU Lectures) to keep clinical researchers up-to-date on regulatory, quality, and methodological aspects of clinical research.

The 500th participant is welcomed in an advanced GCP course of CTU Bern.

CTU Bern formally becomes an institute of the University of Bern and is independent of the Department of Biomedical Research. Clinical Investigation is no longer a division of CTU Bern but an independent unit at Inselspital Bern. Both units still work closely together.

CTU Bern has its first external audit.

CTU Bern successfully completes two certification audits and receives the ISO 9001:2015 certification. This certificate independently confirms that the unit’s quality management system adheres to the ISO 9001 standard.

Clinical Investigation Unit moves into the new sitem-insel building

CTU staff provide more than 1,000 hours of consulting in more than 300 distinct consultations in 2019.

Plans to form a larger umbrella organization for clinical research at the Faculty of Medicine materialize (Department of Clinical Research).

The COVID-19 pandemic has a major impact on how clinical research is done (boost for platform and adaptive trials, fast approvals, slow enrolment, remote monitoring etc.) and on how people work at CTU Bern (e.g., offices closed).

A new regulation for clinical trials with medical devices is enforced. The exact impact on independent, academic clinical trials remains still to be seen.

CTU Lectures are given over Zoom. This boosts participation with some lectures having more than 100 attendees.

Urs Fischer becomes professor of neurology at the University of Basel. Sven Trelle is appointed as Director of CTU Bern.

More than 180 projects are supported by CTU Bern (with at least 8 hours) the majority of which are clinical trials. Increasing the number of clinical trials is part of the unit’s strategy.

The audit platform of the Swiss Clinical Trial Organisation conducts its first audit at CTU Bern with a focus on data management processes. A very useful approach for further development.

Eva Segelov starts in her position as new Professor of Clinical Research at the university and as Director of the Department of Clinical Research.

CTU Bern has around 50 employees with approximately 35 fulltime equivalents. The yearly budget approaches CHF Mio 5.0.

CTU Bern forms one part of the new Department of Clinical Research.