Oct 13, 2020
Should Risk-Based Quality Management (RBQM) begin with technology or process? That’s one of the important issues discussed in Gary Tyson’s interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium (MCC). Tyson founded Pharma Initiatives eight years ago after the sale of Campbell Alliance to what is now Syneos, where he had built the clinical development and medical affairs practice area. It’s not unusual for Tyson’s clients to engage his organization to help them select and implement RBQM software systems. But RBQM “is not a classic software implementation” project because RBQM implementation doesn’t start with technology selection. Technology is only one of the three elements of transformative change needed to implement successful RBQM programs – you should take a three-pronged approach that includes people, process, and technology, says Tyson. Organizations need to educate staff about RBQM fundamentals and establish their RBQM process before considering RBQM software. Since RBQM is not highly prescriptive in terms of mandates established by regulatory agencies, it is more dependent on the particular needs of the clinical trial stakeholder. And small sponsors should engage with their CROs to establish how they will work together to analyze risk and implement risk controls. In addition, says, Sullivan, your CAPA process should also be connected to RBQM. Tyson suggests to his clients that they begin RBQM with a pilot project, using affordable tools available on the market today.