During the 2022 WCG MAGI Clinical Research Conferences in Boston and Las Vegas, Linda Sullivan invited attendees to stop by the CTO podcast booth and share their ideas about the top three things that the industry should do to improve how clinical trials are designed and executed. Don’t miss this rare opportunity to hear ideas from investigative site staff, clinical trial participants, and other industry stakeholders about opportunities to improve clinical research.
Dec 13, 2022•55 min
Hannah Reimer and Tara White at Temple University joined Linda Sullivan to discuss their collaboration to develop a systematic way of including researchers in the clinical care of patients. Faced with the challenge of not having patients eligible to enroll in clinical study due to low adherence to standard of care guidelines, the research team reached out to the clinical care team to explore how to address the problem. Working collaboratively with the quality improvement group, they were able to...
Dec 08, 2022•26 min
Patricia Roselle, global head, patient stakeholder engagement at Sanofi ,joins Linda Sullivan to share insights about the success of an innovative model that directly and intentionally collaborates with patient advisors and advocacy groups from around the world to co-design Sanofi’s end-to-end approach to medicines development.
Dec 08, 2022•31 min
Have you ever had a resume come across your desk that looked too good to be true? You bring the candidate in for an interview where they say all the perfect things, only to hire them and find out they were nothing like they led you to believe? This is the question explored during Linda Sullivan’s interview with Kylie Sands, Carly Lovelett, and McKailey Lyndaker at St Lawrence Health. The organization revamped their job interviewing process to better learn how a potential candidate could fit into...
Dec 02, 2022•20 min
Brandi Bratrude at Boston Children’s Hospital and Mona Li at the Dana Farber Cancer Institute joined Linda Sullivan to discuss a successful Intern-to-FTE pipeline program at the Boston Children’s Hospital. The program, made possible through a collaboration with the Office of Workforce Development at the Dana-Farber Cancer Institute, works to ensure that youth and adults from underserved and underrepresented Boston neighborhoods have the access, skills, and resources necessary to pursue healthcar...
Nov 29, 2022•27 min
Is there a way for sponsors and clinical trial sites to donate unused lab kits and supplies for humanitarian aid? This is the question explored during Linda Sullivan’s interview with Mark Ryan vice president, head site management Americas region, and Donna Libretti-Cooke director of contracting and budgeting at Bayer and founder, Greg Folz and program coordinator, Josh Kravitz at Kits4Life. MedSurplus Alliance’s Kits4Life program was started to provide the means for unused clinical research supp...
Nov 23, 2022•31 min
How are organizations now tracking and assessing risk with risk-based quality management (RBQM) systems in the wake of new clinical trial designs and the COVDI-19 pandemic? That’s one of the key questions explored during Linda Sullivan’s interview with Duncan Hall, CEO and Founder at TRI — The Risk-Based Monitoring Company, which specializes in making RBQM simpler and more accessible. Duncan, who appeared on CTO Episode #4 (August 2020), discusses how RBQM has been transformed and become more ut...
Sep 30, 2022•43 min
How can organizations use advanced analytics to complement, enhance, and accelerate current QA practices? That’s one the key questions explored during Linda Sullivan’s interview with Timothé Ménard, Head Quality Data Science & Bioethics Coach in Product Development Quality at F. Hoffmann-La Roche. In his role at Roche, Ménard has been leading the product development Quality Data Science Team since January 2018. From simple analytics methods to machine learning, Ménard’s team is creating and impl...
Sep 21, 2022•39 min
What’s the best way to develop world-class Quality Assurance (QA) professionals in the clinical trials industry? That’s one of the key questions explored during Linda Sullivan’s interview with David Fryrear, Executive Vice President and Head of Quality Assurance at Astellas Pharma, Inc. Clinical QA was first defined as “auditing,” says Fryrear, but it has morphed into a critical element in Quality Management Systems and is continuing to transform itself today. In addition, Fryrear notes, QA is n...
Jul 29, 2022•39 min
In the final part of our three-part series on the value of Quality Tolerance Limits (QTLs), WCG Senior Advisor Linda Sullivan talks about methods for early detection of risk with Steve Young and Keith Dorricott. Young is the Chief Scientific Officer at CluePoints, who oversees the research and development of advanced methods for data analytics, data surveillance, and risk. Dorricott is a Master Black Belt who has spent more than 15 years applying process improvement techniques to address clinica...
Jun 07, 2022•28 min
In the second installment of our three-part series on defining and using Quality Tolerance Limits (QTLs), WCG Senior Advisor Linda Sullivan talks about the process of defining QTLs with Steve Young and Keith Dorricott. Young is the Chief Scientific Officer at CluePoints, who oversees the research and development of advanced methods for data analytics, data surveillance, and risk. Dorricott is a Master Black Belt who has spent more than 15 years applying process improvement techniques to address ...
Jun 06, 2022•29 min
In the first of this three-part series on defining and using Quality Tolerance Limits (QTLs), WCG Senior Advisor discusses the relationship between QTLs & KRIs with Steve Young and Keith Dorricott. Young is the Chief Scientific Officer at CluePoints, who oversees the research and development of advanced data analytics, data surveillance, and risk methods. Dorricott is a Master Black Belt who has spent more than 15 years applying process improvement techniques to address clinical research problem...
May 26, 2022•31 min
What’s the current status of diversity efforts in clinical trials given the recent FDA draft guidance and the introduction of the Diverse and Equitable Participation in Clinical Trials (DEPICT) in Congress? That’s the main topic explored during WCG Senior Advisor’s interview with Lori Abrams, Vice President, Patient Advocacy & Clinical Research Diversity, at WCG. Abrams has a long history of improving clinical drug development by including patients, caregivers, and advocacy groups into every asp...
May 23, 2022•32 min
What are the most important lessons learned by clinical research sites from having to deal with the COVID-19 pandemic the last two years, and what are the challenges these sites face going forward?. That’s the key topic explored during Senior Advisor Linda Sullivan’s interview with Sandys Smith, Senior Vice President, Clinical Solutions and Strategic Partnerships for WCG. Smith, who has spent her career partnering with physicians and other healthcare stakeholders to drive customer value and clin...
May 21, 2022•32 min
What’s the current status of the WCG Avoca Quality Consortium (AQC) — the exciting new collaboration between Metrics Champion Consortium (MCC) and Avoca Quality Consortium, whose mission is to elevate clinical trial quality, drive efficiency, and mitigate risk through industry collaboration by providing a more holistic approach to improving clinical trial operations. That’s the key topic explored during Senior Advisor Linda Sullivan’s interview with Michelle Webb, Vice President of WCG’s AQC. Th...
Mar 28, 2022•30 min
What are best strategies for utilizing the promise of machine learning, deep learning, and artificial intelligence (AI) in clinical trials? That’s the key topic explored during MCC’s Linda Sullivan’s interview with Jonathan Rowe, Principal at ZS, where he leads the R&D, quality, and operations risk management function, and former head of clinical development, quality performance, and risk management at Pfizer. In general, Rowe notes, AI systems today are becoming increasingly useful in the indus...
Feb 10, 2022•34 min
How will the collaboration between Metrics Champion Consortium (MCC) and Avoca Quality Consortium (AQC) help develop new deliverables for the clinical trials industry? That’s the key topic explored during MCC’s Linda Sullivan’s special interview with Patty Leuchten, Founder and CEO of WCG Avoca. In September 2021, WCG announced exciting news: AQC and MCC were joining forces in 2022 to form a single industry consortium. AQC and MCC are similar in having SMEs facilitate the research and developmen...
Jan 12, 2022•33 min
What were the top takeaways from the interactive metric sessions led by Keith Dorricott at the recent 4th Annual WCTG/MCC Clinical Trial Risk and Performance Management Virtual Collaborative Summit? That’s the key topic explored during Linda Sullivan’s interview with Dorricott, a Master Black Belt and veteran CRO executive who serves as an expert MCC work group leader and contributor. Dorricott discusses outcomes from several Summit breakout group sessions, including, Selection, Implementation a...
Nov 23, 2021•35 min
How can small sponsors develop the right strategies to deal with the challenges of aggregating vital trial data? That’s one of the key topics explored during Linda Sullivan’s interview with Rohit Nambisan and Todd Johnson of Lokavant. The guests discuss the difficulties of getting needed data from outside vendors, standardizing the data and implementing the necessary analysis. Some smaller sponsors, the guests explain, historically have not realized the benefits of aggregated data, especially me...
Sep 27, 2021•33 min
How can sponsors with limited resources be most successful in outsource RBQM? That’s one of the key topics explored during Linda Sullivan’s interview with Liz Wool, founder, and president of the Wool Consulting Group. Wool is a recognized industry expert on CRO-vendor oversight and management, certified CRA (ACRP), and an instructional designer, master trainer and expert in delivering virtual training courses that engages the learners. Wool and Sullivan discuss the evolution of risk-based qualit...
Sep 22, 2021•29 min
How can organizations best use data to tier sites into groups to support “fit for purpose” risk monitoring? That’s one of the key issues explored during Linda Sullivan’s interview with two CTO guests: Tammy Finnigan, Chief Operating Officer and Elizabeth Robertson RBM operations consultant at Triumph Research Intelligence. Some sponsors are still running traditional monitoring models while they begin developing “fit for purpose” monitoring – an approach that deploys monitoring resources to the s...
Sep 17, 2021•33 min
Is there a common set of key risk indicators (KRIs) the clinical trials industry is monitoring to achieve world-class Risk-Based Quality Management (RBQM)? That’s one of the key issues explored during Linda Sullivan’s interview with two returning CTO guests: Artem Andrianov, CEO of Cyntegrity and Johann Proeve, Chief Scientific Officer at Cyntegrity. Andrianov and Proeve note that they do see a set of “golden” KRIs – a subset of KRIs that many of their customers are monitoring with their RBQM sy...
Aug 22, 2021•41 min
Centralized monitoring clinical trial programs can catch outlying data points in almost real time and quickly notify the clinical trial study team . T hat’s one of the key takeaways from Crupa Kurien’s interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium. Kurien is the central monitoring manager in the RBQM program at Pfizer, who currently manages and provides oversight for the company’s COVID-19 portfolio. For the most part, Kurien says, Pfizer’s central mo...
Aug 10, 2021•33 min
Sponsors should approach Risk-Based Quality Management (RBQM) implementation focusing on supporting some important critical factors, including company culture, trial design, trial operations, as well as continuous improvement. That’s one of the key takeaways from Sam Sather’s interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium. Sather co-founded Clinical Pathways, a North Carolina-based consulting firm and is the company’s Vice President who leads quality m...
Jun 30, 2021•41 min
With the anticipated adoption of ICH-E8-R1 this summer, there’s going to be even more attention on patient voice and engagement and critical-to-quality factors. MCC’s Quality by Design (QbD) - Risk Based Quality Management (RBQM) – Quality Improvement community of practice group is has already developed practical tools to help optimize quality by design. These are some of the key topics discussed in Keith Dorricott’s interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion...
Jun 14, 2021•37 min
How can you best engage patients in the design and execution of your clinical trials? That’s one of the important topic discussed in Lori Abrams’s interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium (MCC). Abrams is the Executive Director of Patient Advocacy and Diversity at WCG and the former Director of Diversity & Patient Engagement at Bristol-Myers Squibb (BMS). It’s incredibly important to involve minority populations in your clinical trials to deal wi...
May 27, 2021•38 min
MCC launched its groundbreaking monitoring process metrics working group last year with the purpose of developing new metrics that take into account changes in the clinical monitoring process, including risk-based assessment and centralized monitoring integration. That’s the important topic discussed in Keith Dorricott’s interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium (MCC). The collaborative working group started with the challenging process of develop...
Apr 26, 2021•32 min
MCC has developed a valuable risk assessment and mitigation management tool that organizations can use as the basis for implementing the risk-based quality management process outlined in ICH E6 (R2), section 5.0. That’s the important topic discussed in Keith Dorricott’s interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium (MCC). Dorricott facilitates MCC’s QbD-RBQM-Quality Improvement Community of Practice Group. Dorricott describes how MCC members have work...
Apr 13, 2021•36 min
MCC metric toolkits include comprehensive sets of time, cost, and quality metrics defined at portfolio, study, and site levels – but how do organizations decide which metrics to include in their metric reports? That’s the important topic 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 work gro...
Apr 01, 2021•29 min
How do MCC metric development work groups determine what metrics to include in a metric toolkit? That’s one of the important topics 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 work groups. Dorricott describes the MCC Metric Development Framework – a multi-step, structured approach MCC work...
Mar 24, 2021•34 min
