Did you know? About 4,000 clinical research employees in Germany have a valuable voice in the life sciences industry thanks to The Federal Association of Contract Research Organisations, (Bundesverband Medizinischer Auftragsinstitute, BVMA e.V.). Founded in July 1991, BVMA represents contract research organizations (CROs) based in German-speaking countries.
Not long ago, clinical trials involved 100% onsite monitoring in an effort to ensure high data quality. But how effective and efficient was that process? Several analyses have shown that only 1-2% of data is corrected as a result of source data verification (SDV). Therefore, the concept of risk-based monitoring (RBM) was born. The goal was to complete a more targeted monitoring (<100% SDV) without compromising patient safety or data quality.