Clinical Trial Optimization

New Benchmarks on Protocol Design Practices and their Impact on Clinical Trial Performance and Efficiency with Ken Getz and Linda Sullivan

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 ...

Twin Peaks — Measurements & Goals: Pros and Cons of Using High-Level Portfolio Milestone Timeliness Metrics with Linda Sullivan and Keith Dorricott

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 d...

You’ve Detected a Risk … Now What?! The Challenges Organizations Face Accepting and Acting on Risks Identified by Centralized Monitoring with Linda Sullivan, Steve Young, and Keith Dorricott

Deploying Streamlined Surveys and Generating Metrics to Assess Vendor-Sponsor Relationships with Linda Sullivan and Keith Dorricott

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 W...

TMF Accredited Training Program is Key To Building Your World-Class TMF with Linda Sullivan and Sholeh Ehdaivand

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 “the story of the clinic...

How the Right Metrics Enable You to Develop World-Class Sponsor-CRO Relationships with Linda Sullivan, Steve Crow, and Keith Dorricott

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 ...

Implementing the Successful Total Cost of Quality Model in Clinical Trials: Yes, You Can —and Must —Eliminate Waste with Linda Sullivan and Keith Dorricott

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 origins of the Total ...

Implementing Successful RBQM Programs Requires Three-Pronged Approach – It’s Not Just Software Implementation, with Linda Sullivan and Gary Tyson

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...

Optimizing Human Performance in Clinical Trials by Applying Gilbert’s Behavioral Engineer Model with Linda Sullivan and SAM Sather

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...

The Case for Centralized Monitoring: Optimizing Data Quality and Risk Management with Linda Sullivan and Steve Young

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, clini...

Striving for Reliability: Optimizing Patient Reported Data through World-Class Design Management with Linda Sullivan, Nat Katz, and Art Morales

Can patients be trained to report their symptoms more accurately? That’s one of the key topics discussed in Nat Katz’s and Art Morales’ interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium (MCC). Katz, the Chief Science Officer of WCG-Analgesic Solutions and Morales , Vice President, Technology Solutions at WCG, assert that, with proper design and implementation, you can structure clinical trials, such as pain management studies, so that patients learn how t...

The Upside of Centralized Monitoring During a Pandemic: Linda Sullivan, Duncan Hall, and Rachel Oakley on Optimizing Clinical Trials through Innovative RBQM Technology

How are clinical trial companies pivoting to implement Risk-Based Quality Management programs during the pandemic? That’s one of the deep dives explored in Duncan Hall’s and Rachel Oakley’s interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium (MCC). Hall, founder and CEO of Triumph Research Intelligence (TRI) and Oakley, Vice President of RBQM Services at TRI, note that, when the COVID-19 pandemic first hit, CROs and sites performed risk assessments on their...

Get Rid of Those Silos: Linda Sullivan, Artem Andrianov, and Johann Proeve on How To Optimize Clinical Trials through RBQM

What’s the secret to success for implementing a world-class holistic approach to a Risk-Based Quality Management (RBQM) system? That’s one of the key topics from Artem Andrianov‘s and Johanna Proeve’s interview with Executive Director of WCG’s Metric Champion Consortium (MCC), Linda Sullivan, MBA. Andrianov, CEO, and Proeve, Chief Science Officer at Cyntegrity emphasize the importance of developing a clinical trial platform that enables your organization to manage the entire quality management c...

Turning Insights Into Action: Linda Sullivan and Ken Getz on How Metrics and Benchmarking Provide a Path To Optimizing Clinical Trials

"What impact does a remote clinical team operating model have on clinical trial performance?" That’s one of the hot topics from Ken Getz’s interview with Executive Director of WCG’s Metric Champion Consortium (MCC), Linda Sullivan, MBA. He describes several projects that the Tufts Center for the Study of Drug Development (Tufts CSDD) is currently working on; ones that will provide robust, data-driven analysis and strategic insights that help drug development professionals improve pharmaceutical ...

A Discussion with Laurie Halloran on Now Is the Time: Making Your Clinical Trial More Resilient

In this episode, host Linda Sullivan, MBA, Executive Director of WCG's Metric Champion Consortium (MCC) chats with Laurie Halloran, founder of the Halloran Consulting Group, about how she developed an on-demand drug development team that can fill in gaps in the clinical trial process for life science companies, whether these involve regulatory strategy or execution, or quality, clinical, or manufacturing issues. The COVID-19 pandemic has resulted in these companies having to pivot to more virtua...