Implementing Successful RBQM Programs Requires Three-Pronged Approach – It’s Not Just Software Implementation, with Linda Sullivan and Gary Tyson
Release Date: 10/13/2020
Heard It on the Street: Three Actions Industry Should Take To Improve Clinical Trial Design and Execution
Clinical Trial Optimization
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.
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WCG Innovation Challenge Finalist Temple University Discuss Closing Gap Between Clinical Research and Clinical Care with WCG Senior Advisor Linda Sullivan
Clinical Trial Optimization
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 drive changes that resulted in improved adherence to standard of care guidelines which enabled the...
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WCG Innovation Challenge Finalist Sanofi Discusses Benefits of Collaborating with Patients to Improve Clinical Research Design & Outcomes with WCG Senior Advisor Linda Sullivan
Clinical Trial Optimization
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.
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WCG Innovation Challenge Finalist St Lawrence Health Discusses Evaluating Job Candidates’ Soft Skills with WCG Senior Advisor Linda Sullivan
Clinical Trial Optimization
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 their department and help everyone succeed. The new approach that assesses “soft skills”, as...
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WCG Innovation Challenge Finalist Boston Children’s Hospital Discusses DEI Workforce Development Program with WCG Senior Advisor Linda Sullivan
Clinical Trial Optimization
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 healthcare careers.
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WCG Innovation Challenge Winner Bayer Discusses Kits4Life Program with WCG Senior Advisor Linda Sullivan
Clinical Trial Optimization
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 supplies to be repurposed by organizations around the world that are qualified to accept...
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How New Trial Designs & the Pandemic Have Altered Risk-Based Monitoring with Duncan Hall and WCG Senior Advisor Linda Sullivan
Clinical Trial Optimization
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 utilized in the last two decades, how the pandemic accelerated further RBQM changes, and...
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Deploying Advanced Analytics to Enhance QA, with Timothé Ménard and WCG Senior Advisor Linda Sullivan
Clinical Trial Optimization
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 implementing data-driven solutions that help understand, early detect, and predict...
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The Evolving Role of the QA Professional with David Fryrear and WCG Senior Advisor Linda Sullivan
Clinical Trial Optimization
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 now a resource for business partners and is a key contributor and independent voice...
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QTLs & Early Detection of Risk (Part III of the QTL Series) with Steve Young, Keith Dorricott, and WCG Senior Advisor Linda Sullivan
Clinical Trial Optimization
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 clinical research problems. Young and Dorricott co-led a groundbreaking, WCG Metrics Champion Consortium...
info_outlineShould 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.