I just wrapped a 4-hour ACRP module on risk-based quality management last month, and after 20+ years in trials it struck me how quickly our core competencies are shifting. For those mapping growth plans for 2025, are you focusing on ICH E6(R3) updates, decentralized trial operations, or AI literacy for monitoring — and do you have a course or certificate that truly helped?
I’d prioritize E6(R3) but the biggest lift for us came from a tiny AI monitoring pilot: mirror one site’s data in a sandbox, run Power BI’s anomaly detection to flag outliers, and capture the review path in an audit-trail template so QA buys in. > AI literacy for monitoring — and do you have a course or certificate that truly helped? No cert — TransCelerate’s RBQM materials (https://www.transceleratebiopharmainc.com/rbm/) plus two practice sprints beat any class. Did you bake thresholds into KRIs or keep them case-by-case?
Quick example: I’d anchor 2025 on E6(R3) by running a 2‑hour CTQ/risk workshop per study and building a tiny “risk library” you reuse, then layer AI monitoring only after you’ve locked down CDISC mappings and audit trail checks — measure twice, monitor once; TransCelerate’s RBQM tools are a good scaffold: Risk Based Monitoring Solutions - TransCelerate.