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Clinical Trial Optimization
41 minutes | 15 days ago
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 Cost of Quality Model in the US and its early adoption in Japan. He also discusses the basic idea that there is a balance between good and poor cost of quality – there are costs to building quality in, but much greater costs when quality does not meet the required standard. The costs of quality failure can include protocol amendments, low enrollment, extended timelines, rework, reputational damage and delay to market. Dorricott suggests- that there be greater accountability for those responsible for certain processes rather than a simple reliance on others to find issues later and then have the cost of fixing them. Dorricott says that there are now ways to estimate the costs of poor quality, and that indeed the biggest challenge for the clinical trials industry is how to become more efficient and ultimately bring more high-quality therapeutics to market sooner to impact patients’ lives.
47 minutes | a month ago
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 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.
47 minutes | 2 months ago
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 clinical trials industry, a science that is particularly significant today given the integration of quality risk management and GCP. HPI is about structuring your organization in ways that enable your employees to be star performers and engage in critical thinking, Sather says. “It’s based on doing a business analysis and defining what matters … and is very linked to metrics and what is an enforceable agreement, and [involves] the concepts of gap analysis and root cause as well.” she explains. One HPI model successfully used by Sather is Gilbert’s Behavior Engineering Model (BEM), which considers factors on two levels: environmental and individual. All factors included in these levels are equally important and need to be present for individuals to perform well. For example, organizations implementing risk-based management should consider whether it truly provides team members with the information, resources, incentives, knowledge, capacity, and motivation they need to succeed. The pandemic has pushed the industry to be agile and some stakeholders have succeeded, and others haven’t, she concludes.
36 minutes | 3 months ago
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, 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.
39 minutes | 3 months ago
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 to better report their symptoms. With proper training, patients learn to accurately report their symptoms, resulting in more reliable data, according to Katz and Morales. During COVID-19, they add, sponsors have had the opportunity to examine ways to introduce new technologies, such as telehealth, to clinical trial operations and to use more science-based tools for evaluating the performance of clinical trials. COVID-19 also has accelerated the scientific evaluation of clinical sites by optimizing the analysis of patient data. The result: Clearer and more reliable data collected during the conduct of study — without unblinding the data. 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.
42 minutes | 3 months ago
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 existing studies. Then those organizations took advantage of innovative technology that had a key tool for optimizing clinical trials — centralized monitoring. According to Hall and Oakley, that tool enables critical oversight and monitoring of investigational sites, even when in-person visits are not feasible. They point out that regulatory agencies are issuing new guidance during the pandemic, and that sponsors, CROs, and sites need to figure out how to comply with both those new mandates as well as existing rules. According to Hall and Oakley, there has been a renewed sense of community in the industry in dealing with the pandemic as stakeholders try to stay current through a variety of trusted sources, including MCC’s weekly COVID calls. Finally, they note, one component for optimizing clinical trials is taking center stage — training, especially in the area of RBQM. 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.
42 minutes | 3 months ago
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 cycle rather than continuing with traditional silo-based approaches. This comprehensive approach, they explain, enables pharmaceutical companies to become more efficient in reducing risk, which is especially important during the current pandemic. In addition, they note, in the COVID-19 era, more organizations have had to turn to holistic risk-based quality management systems because, for example, Excel doesn’t always work for managing RBQM, especially in larger clinical trials. Today, both CROs and sponsors are implementing innovative RBQM technology and asking for additional training to deal with data quality deterioration and other issues brought about by the onslaught of the pandemic, according to Andrianov and Proeve. Listen to this episode to find out how COVID-19 has magnified festering clinical trial shortcomings and why it’s essential that pharmaceutical company leaders become “data scientists.” 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.
32 minutes | 5 months ago
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 virtual experiences. At the beginning of the outbreak, she notes, her group organized town halls that made it clear to stakeholders that life science companies had to implement telehealth and other remote monitoring solutions to protect patient safety. As a result of the pandemic, Halloran explains, her group is reviewing clinical trial protocols to determine how technology can be better utilized in the collection of clinical trial data. In conclusion, Halloran says, “don’t waste this opportunity” to make your clinical trial program more resilient. Interested in attending the MCC Clinical Trial Risk and Performance Management vSummit September 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.
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