Press Releases

Rho Experts Share Best Practices for Managing Risks in Clinical Trials

Free webinar offers insight into recent Good Clinical Practice (GCP) revisions on sponsor responsibilities for risk management

WHAT:                 Rho, a full-service contract research organization (CRO) that helps pharmaceutical and biotechnology companies bring their products to market through high-quality clinical research services, will outline and provide tips on the U.S. Food and Drug Administration (FDA)’s new sponsor responsibilities for managing risks in clinical trials in an upcoming webinar, “Managing the Risks of Implementing E6R2.” The webinar will take place on Wednesday, March 25, from 1-2 p.m. EST.

Rho’s Senior Project Manager Missy Lavinder, Senior Project Manager Nick Poulson and Associate Director of Clinical Management Marina Acosta Enslen will present the webinar, which will provide insights into ICH E6 (R2), the FDA’s recent revision to Good Clinical Practice (GCP) guidelines, and how sponsors can better understand and actively manage the risks to quality in clinical trials via a Risk-Based Quality Management (RBQM) approach. ICH E6 (R2) requires sponsors to develop and manage quality risk assessments, a written RBQM, strategic data reviews and a robust RBQM framework. This webinar will explain why RBQM is the foundation for a targeted, risk-based approach to monitoring and how understanding a trial’s most critical risks can help identify the most valuable monitoring strategy.

WHO:                    Missy Lavinder, senior project manager at Rho, has 18 years of clinical research experience as a research coordinator, in-house CRA, study start-up specialist, Clinical Operations Manager and Project Lead. She has experience managing all phases of clinical trials and is experienced in budget management, calculating and tracking site payments, expedited study start-up processes, essential document review, informed consent form review, IRB submissions, overseeing reviews/submissions to Central IRBs, ICH/GCPs and SOP and procedural document development and review. She has a strong understanding of all aspects of product development which has allowed her to successfully lead teams to meet timeline deliverables for various multi-center trials.

Nick Poulson, senior project manager at Rho, has 8 years of clinical trial experience managing, monitoring, and coordinating Phase 2-4 clinical trials across various therapeutic areas, including pain. He received his doctorate Degree in Cell Biology with a focus on cell division and the cell cycle from Duke University. With this experience also comes expertise in managing at home reported assessments via paper diaries and ePRO devices to ensure timely and accurate reporting by subjects.  Additionally, he has a strong understanding of clinical trial management and delivery requirements that has allowed him to successfully lead teams to meet timeline deliverables for various multi-center trials.

Marina Acosta Enslen, associate director, clinical management at Rho, has 19 years of experience across Phase 2 through 4 studies. She has managed regional and global clinical teams on complex trials, managed clinical teams, developed site and monitor training tools, developed clinical monitoring plans and successfully delivered operational timelines. Marina has a strong understanding of clinical trial management and delivery requirements that has allowed her to successfully lead teams to meet deliverables.

WHEN:                 March 25, 2020
                                1-2 p.m. EST

WHERE:               Register to attend this free webinar at this link.

DETAILS:              For media inquiries, please contact Melody Goforth at Largemouth Communications,                                       919-459-6482, melody@largemouthpr.com.   

ABOUT:                Rho, a privately held, contract research organization (CRO) located in Research Triangle Park, NC, provides a full range of clinical research services across the entire drug development process. For more than 35 years, Rho has been a trusted partner to some of the industry’s leading pharmaceutical, biotechnology, and medical device companies as well as academic and government organizations. Our commitment to excellence, our innovative technologies, and our therapeutic expertise accelerate time to market, maximize returns on investment, and lead to an exceptional customer experience. Please follow us on Facebook, LinkedIn and Twitter.

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