1 June 2023
Minimising the risks of extra costs
Clinical trials of categories B and C can now be insured at the DKF for Swissmedic inspections.
Swissmedic plans to intensify its inspection activities between 2023 and 2026: Every year 10% of ongoing clinical trials in categories B and C will be inspected. These inspections are intended to ensure conformity with legal requirements in the therapeutic products sector and to guarantee patient safety.
An offer for more cost security
The costs of an inspection by Swissmedic should not be underestimated. In order to cushion the financial pressure and offer study teams a degree of security, DKF has devised a new solution for its research groups: An inspection insurance, which minimises the risk of unexpected costs and better prepares the research groups for a possible inspection.
With a one-time contribution of CHF 1000 per study, the insured parties are covered as follows: DKF covers the costs of up to CHF 15'000 per inspection. Additionally, the DKF Quality Affairs team supports the preparation of the inspection as well as its follow-up. This type of support ensures that the number of possible finings is reduced, if not eliminated, and that the effort required for post-processing is significantly reduced.
"In view of the increasing number of inspections by Swissmedic, I consider the inspection insurance a useful and necessary support for research groups."
Prof. Jörg Leuppi, member of the DKF Executive Board and DKF research group leader
Preparation is half the battle
Roland John, Head of Quality Development at DKF, knows both the concerns of the study teams and the requirements of the inspectors. Accordingly, he recommends being well prepared for an inspection. An important prerequisite for this is a well-functioning Quality Management System. The DKF Quality Affairs team can assist in setting this up with the "Orca" web application, which is tailored to the needs of academic research groups. Numerous DKF research groups are already using Orca successfully. Among them is Jörg Leuppi, who recalls: "Good preparation favors a professional inspection process and saves resources as well as nerves."
Inspection insurance - new offer for research groups
- Assumption of inspection costs (max. CHF 15'000 per inspection)
- High Level Risk Assessment
- Support in setting up the QMS
- Support in the preparation of the inspection
- Support during the inspection and follow-up
- Support in the preparation of the CAPA plan
Criteria for take out
- The insurance is taken out before Swissmedic announces an inspection.
- The insurance covers an Investigator-initiated clinical trial.
- The Sponsor-Investigator of the trial is a member of a DKF research group.
- For multicenter studies, only the centre of the DKF research group is insured.
- The study must maintain a quality management system (QMS) with a dedicated person responsible for the QMS.