How are benchmarks on protocol design practices changing and what’s the impact of the exploding number data points in clinical trials? That’s one of the important issues discussed in Ken Getz’s interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium (MCC). Getz is the newly appointed director and a professor at the Tufts Center for the Study of Drug Development (CSDD), Tufts University School of Medicine. Getz discusses the results of a recently released study by

How can you best measure whether vendors are meeting study milestone goals? That’s one of the important issues discussed in Keith Dorricott’s interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium (MCC). Dorricott is a Director at Dorricott Metrics & Process Improvement Ltd in the UK and facilitates many MCC metric development and community of practice groups. Timeliness metrics — measurements that assess whether study milestones are achieved by their target date

What action steps can organizations take to review risks discovered through centralized monitoring? That’s one of the important issues discussed in Steve Young’s and Keith Dorricott’s interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium (MCC). Young and Dorricott co-lead MCC’s Centralized Monitoring Community of Practice Group, which began in 2017. This group includes representatives of sponsors, CROs, centralized monitoring vendors, and consultants. Young is

How can sponsors and CROs assess relationships through the use of streamlined surveys and careful review of results? That’s one of the important issues discussed in Keith Dorricott’s interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium (MCC). Dorricott is a Lean Sigma Master Black Belt with extensive experience in process improvement at CROs and is a Director at Dorricott Metrics & Process Improvement Ltd in the UK. He leads the MCC Vendor Oversight Metric Work G

How can clinical trial organizations achieve TMF excellence? That’s one of the important issues discussed in Sholeh Ehdaivand’s interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium (MCC). Ehdaivand, President and CEO of LMK Clinical Research Consulting, a certified woman-owned TMF consulting company, notes that the TMF (Trial Master File) is the collection of documents and data associated with the clinical trial. Often referred to as

Can metrics play a crucial oversight role in establishing an effective and efficient relationship between sponsors and CROs? That’s one of the important issues discussed in Steve Crow’s and Keith Dorricott’s interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium (MCC). Crow, Associate Director, Performance and Training, Clinical Operations at GW Pharmaceuticals (known as Greenwich Biosciences in the U.S.) explains that the growth of the company’s portfolio of st

What’s the best way to get rid of unproductive waste in clinical trials? That’s one of the important issues discussed in Keith Doricottt’s interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium (MCC). Keith Dorricott, a Lean Six?? Sigma Master Black Belt with extensive experience in process improvement at CROs, is now Director at Dorricott Metrics & Process Improvement Ltd. in England. This sentence makes no sense. Dorricott describes the origin

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 engag

How can sponsors, CROs, and sites improve the performance of clinical researchers? That’s one of the important issues discussed in SAM Sather’s interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium (MCC). Sather, Cofounder and Vice President of Clinical Pathways (CP), LLC, a consulting firm in North Carolina, leads the quality management consulting services for the company. She talks about the critical importance of human performance improvement (HPI) for the clini

How can CROs and sponsors detect potential problems and issues in clinical trial conduct and data quality? That’s one of the critical issues discussed in Steve Young’s interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium (MCC). Young, Chief Scientific Officer at CluePoint, discusses how risk-based quality management (RBQM) methodology, data analytics, and data surveillance are being utilized today to go beyond just ferreting out fraud.  Now, Young says, clinical trial stakeholders are deploying advanced statistical engines to detect quality and data breaches in investigational studies. According to Young, while there are still instances, to varying degrees, of major misconduct in clinical trials, CROs and sponsors are increasingly turning to online solutions to risk planning. It’s important, he adds, that when risks are discovered, the solutions are integrated into the workflow of clinical trials. In fact, Young asserts, one of the biggest challenges facing the industry today is to embrace change and accept the use of centralized monitoring data to aid in the discovery and resolution of risk.         Interested in attending the MCC Clinical Trial Risk and Performance Management vSummit Sept. 8-10? Visit https://www.centerwatch.com/mcc-summit-2020. If you subscribe to this podcast, you can use the code POD15 to receive 15% off your registration fee.