27 episodes

Clinical Trial Optimization is a twice-monthly podcast that brings together clinical research stakeholders to exchange ideas, share knowledge, and think creatively about how to oversee, manage and optimize clinical trial planning and execution.  The podcast includes discussions with clinical research industry thought leaders and practitioners about how the industry is transforming clinical research design and operations to speed up the delivery of life-changing therapies. The podcast is aimed at clinical research professionals, including R&D executives, clinical operations managers, study managers, data scientists, quality assurance managers, biostatisticians, principal investigators, clinical research associates (CRAs), safety monitors, clinical scientists and other healthcare professionals.

Clinical Trial Optimization Linda Sullivan

    • Health & Fitness
    • 5.0 • 3 Ratings

Clinical Trial Optimization is a twice-monthly podcast that brings together clinical research stakeholders to exchange ideas, share knowledge, and think creatively about how to oversee, manage and optimize clinical trial planning and execution.  The podcast includes discussions with clinical research industry thought leaders and practitioners about how the industry is transforming clinical research design and operations to speed up the delivery of life-changing therapies. The podcast is aimed at clinical research professionals, including R&D executives, clinical operations managers, study managers, data scientists, quality assurance managers, biostatisticians, principal investigators, clinical research associates (CRAs), safety monitors, clinical scientists and other healthcare professionals.

    How Small Sponsors Can Best Access Clinical Trial Data with Lokavant’s Rohit Nambisan and Todd Johnson and MCC’s Linda Sullivan

    How Small Sponsors Can Best Access Clinical Trial Data with Lokavant’s Rohit Nambisan and Todd Johnson and MCC’s Linda Sullivan

    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 merging hi

    • 33 min
    Outsourcing Oversight of RBQM in Clinical Trials. with Liz Wool and MCC’s Linda Sullivan

    Outsourcing Oversight of RBQM in Clinical Trials. with Liz Wool and MCC’s Linda Sullivan

    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

    • 28 min
    Grouping Investigative Sites into Risk Groups for “Fit for Purpose” Monitoring with Tammy Finnigan, Elizabeth Robertson, and MCC’s Linda Sullivan

    Grouping Investigative Sites into Risk Groups for “Fit for Purpose” Monitoring with Tammy Finnigan, Elizabeth Robertson, and MCC’s Linda Sullivan

    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

    • 32 min
    RBQM in Clinical Research with Cyntegrity’s Artem Andrianov and Johann Proeve and MCC’s Linda Sullivan

    RBQM in Clinical Research with Cyntegrity’s Artem Andrianov and Johann Proeve and MCC’s Linda Sullivan

    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

    • 40 min
    Optimizing Central Monitoring with Pfizer’s Crupa Kurien and MCC’s Linda Sullivan

    Optimizing Central Monitoring with Pfizer’s Crupa Kurien and MCC’s Linda Sullivan

    Centralized monitoring clinical trial programs can catch outlying data points in almost real time and quickly notify the clinical trial study team. That’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,

    • 33 min
    RBQM’s Maturity Model with Sam Sather of Clinical Pathways and MCC’s Linda Sullivan

    RBQM’s Maturity Model with Sam Sather of Clinical Pathways and MCC’s Linda Sullivan

    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 manag

    • 41 min

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