Digitalisation in clinical research

KLIFO workshop by BPI and BVMA for digitising clinical studies

MEDIACC was on the topic at the 6th KLIFO workshop ”Digitalisation in clinical research: practical solutions for computerised systems and AI“ represented in Berlin on June 30, 2025. The renowned specialist event is organized jointly by Federal Association of Pharmaceutical Industry (BPI) and the Federal Association of Medical Contracting Institutions (BVMA) organizes and is considered one of the most important platforms for exchange between authorities, sponsors and CROs in German-speaking countries

The workshop covered central topics of digital transformation in clinical research. The focus was on Validation and auditing of computer-aided systems with a risk-based approach and the practical implementation of Guideline for Computerised Systems.

Dr. Marc Brooks (elderbrook consulting GmbH) shed light on the auditor's perspective and provided practical experience in evaluating modern technologies. Dr. Torsten Stemmler (BfArM) offered insights into the regulatory perspective and current regulatory requirements. The innovative World Café format facilitated intensive exchange on three subject areas: Validation of AI systems, Evaluation of electronic source data systems and AI in decentralised studies.

The KLIFO workshop made it clear that the Digitalisation of clinical research continues to gain momentum. The discussions on traditional computerised systems versus AI-powered applications identified opportunities and challenges.