MCC has launched a podcast. We'll be discussing the major issues affecting you, from Quality-by-Design, to risk based quality management and vendor oversight.
Subscribe today!Apple Podcasts Spotify Stitcher Android
In this first episode, host Linda Sullivan 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.
In this episode, Linda chats with the incomparable Ken Getz, the Deputy Director and a professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine, where he conducts research focusing on drug development management and operating strategies and tactics; protocol design practices; and global outsourcing, investigative site, and patient recruitment practices and policies. Getz describes how the Center chooses topics for study, which can emanate from passionate industry professionals or from information gleaned at conferences and then implemented through working groups. At any given time, the Center is working on 12-15 studies, including recent research on participant diversity in clinical trials and upcoming research on possible reduction in time between phases (white space) in clinical trials and patient-centered initiatives. The pandemic has acted as an accelerator in a variety of areas, including remote and virtual visits, telemedicine, and data management, which could result in increased customization and choices to support clinical trials, according to Getz. It’s an exciting time for clinical trial professionals as new technology, including AI, increasingly comes into play. And in the TRIO segment, you’ll want to hear Getz’s answers to these questions: What the biggest challenge facing the clinical trials industry? What’s the best new innovation? What‘s your top optimization takeaway?
EPISODE 3: A discussion with Johann Proeve and Artem Andrianov
EPISODE 4: A discussion with Duncan Hall and Rachel Oakley
EPISODE 5: A discussion with Nat Katz and Art Morales
EPISODE 6: A discussion with Steve Young
Leading the drug-development enterprise in the adoption and utilization of standardized metrics and benchmarks to drive performance improvement. Founded in 2006, MCC is the leading industry association dedicated to the development of standardized performance metrics to improve clinical trials. MCC provides the collaborative environment for biopharmaceutical and device sponsors, service providers and sites to improve clinical-trial development through use of MCC standardized performance metrics.