London, U.K., and Wilmington, N.C.; Jan. 10, 2017 (Business Wire) — Chiltern, a leading global contract research organization, is sending Debra Jendrasek, strategic development partner, to speak at the Summit for Clinical Operations Executives (SCOPE) in Miami, Jan. 24-26.
Jendrasek will join other thought leaders and key decision makers at the conference, collaborating on best practices and offering unique perspectives on various issues related to clinical trial planning and management. Her focus is on risk-based management (RBM), where she offers a new way to look at its implementation and acceptance throughout the industry, especially as teams prepare for the ICH E6 addendum.
“The idea of using RBM practices in clinical research is not new, but is still evolving. It’s something we’ve been contending with as an industry for several years and will continue to develop for some time to come,” Jendrasek said. “We continue to approach these changes as an opportunity to make improvements to our current practices, not as a wide-sweeping overnight change.”
Jendrasek will speak to SCOPE attendees about RBM studies done to date in the industry and what’s to come as well as strategies for RBM in a presentation at 3:20 p.m. Jan. 24, “Chasing a Moving Target: Implementing RBM While Getting Ready for ICH E6.” Additionally, she will host a roundtable discussion at 8:35 a.m. Jan. 26 focused on risk-based monitoring implementation case studies.
Chiltern will be available for meetings during the summit. Stop by Booth 902 or schedule a meeting with the team prior to the event.
For more information on this topic and additional issues challenging drug development today, download Chiltern’s latest newsletter.
About Chiltern
Chiltern, a global contract research organization, is a leading provider of clinical services and solutions in a variety of therapeutic areas with engagement models for biopharmaceutical and medical device industries. Chiltern’s team of more than 4,300, located across 47 countries, provides comprehensive Clinical Development, Medical & Scientific Affairs, Data & Analysis, Pharmacovigilance and Strategic Regulatory services using a collaborative approach for more efficient clinical trials. Visit Chiltern.com to learn more about how Chiltern is Designed Around You®.
