In ACRO’s latest paper published in DIA’s Therapeutic Innovation and Regulatory Science, “Risk-Based Quality Management: A Case for Centralized Monitoring,” ACRO’s RBQM Working Group uses a clinical trial from clinicaltrials.gov to guide readers through a real-life example of centralized monitoring implementation.
Centralized monitoring provides a holistic view of clinical trial data, enabling organizations to identify and address emergent issues more quickly.
By providing a tangible example of centralized monitoring implementation, the paper showcases the benefits of utilizing a risk-based approach to clinical trial monitoring, significantly reducing the need for 100% SDR/SDV.
The paper also highlights the latest trends and takeaways on industry RBM/RBQM adoption, drawing on data from ACRO’s annual RBM/RBQM landscape survey.
By sharing this data, the CROs and technology providers of ACRO hope to continue collaborating across all stakeholders, including ACRO members, sponsors and regulators, to make collective progress towards ensuring that clinical trials are conducted as effectively and efficiently as possible for the benefit of patients.