Deploying Advanced Analytics to Enhance QA, with Timothé Ménard and WCG Senior Advisor Linda Sullivan

<p><span style="font-weight: 400;">How can organizations use advanced analytics to complement, enhance, and accelerate current QA practices?</span> <span style="font-weight: 400;">That’s one the key questions explored during Linda Sullivan’s interview with</span> <span style="font-weight: 400;">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.</span></p> <p><span style="font-weight: 400;">From simple analytics methods to machine learning, Ménard’s team is creating and implementing data-driven solutions that help understand, early detect, and predict clinical and PV quality issues.</span></p> <p><span style="font-weight: 400;">Sullivan notes that, in the l</span><span style="font-weight: 400;">ast six years, many organizations have been implementing risk-based quality management approaches, based on evolving revisions to guidance such as ICH E6R2 and E8R1, which require specific data sets. According to</span> <span style="font-weight: 400;">Ménard, we should leverage and focus not just on clinical trial data but also on operational data, which is sometimes more challenging more than clinical data.</span></p> <p><span style="font-weight: 400;">In regard to identifying and tracking quality issues,</span> <span style= "font-weight: 400;">Ménard points out that analytics now can be applied on program and study levels, which expands critical analysis far beyond the site level and enables biopharmaceutical companies to accelerate</span> <span style="font-weight: 400;">the drug approval process. Ménard notes that his organization has been able to glean key insights from data that might not have been available a decade ago.</span></p> <p><span style="font-weight: 400;">Want to suggest a topic for CTO? Just email Linda Sullivan at</span> <a href= "mailto:lsullivan@wcgclinical.com"><span style= "font-weight: 400;">lsullivan@wcgclinical.com</span