When speaking about interventional vs. non-interventional clinical trials, the terminology used by methodologists and regulatory professionals differs, which can lead to confusion. Since misclassification can have a significant impact on study design and conduct, it’s important to find a happy medium between the terminology used to describe a study and the meaning behind those terms.
Join this webinar to learn how to correctly classify your study as interventional or non-interventional. Featured speakers will discuss how regulatory classification drives study start-up, operational requirements and the costs incurred. They will also discuss whether the use of technology and connected devices impact study classification.
Stuart McCully, PhD (UK), Vice President, Regulatory Advisory Services, RWLP
Stuart McCully is an internationally recognized expert on NIS regulatory intelligence, and the founder of CHCUK Ltd (www.chcuk.co.uk), an on-line service specializing in regulatory intelligence for non-interventional studies. Stuart has more than 15 years’ experience in biomedical research regulatory compliance and is responsible for NIS regulatory advisory services, NIS training and real world and late phase quality improvements. He manages a team of non-interventional study regulatory advisors. Stuart has a PhD in human mechanistic pharmacology and toxicology.
David Thompson, PhD, Sr. Vice President, Real World Evidence Advisory, Syneos Health
David is a health economist with 30+ years of experience in the health economics arena. Prior to joining Syneos Health, he held leadership positions at Quintiles (2012-2016), i3 Innovus/OptumInsight (2000-2012) and PAI (1988-2000). He is also a current committee member of the Clinical Trials Transformation Initiative (CTTI) in real-world evidence (RWE). His areas of expertise include work in economic modeling, retrospective database analysis, trial-based economic evaluations and patient-reported outcomes.
Who Should Attend?
Senior professionals from biopharmaceutical companies involved in:
- Clinical Development
- Regulatory Affairs
- Real World Outcomes
- Real World Evidence
- Late Stage Development
- Non-Interventional Research
What You Will Learn
Join this webinar to learn about:
- The terminology used by methodologists vs. regulatory professionals and how to find a happy medium
- Impact of misclassification on study design and conduct
- How the regulatory classification drives study start-up, operational requirements and the costs incurred
- Whether the use of technology and connected devices impact study classification
Syneos Health™ (Nasdaq:SYNH) is the only fully integrated biopharmaceutical solutions organization. Our company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry leading companies – INC Research and inVentiv Health – we bring together more than 23,000 clinical and commercial minds with the ability to support customers in more than 110 countries. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. To learn more about how we are shortening the distance from lab to lifeTM visit SyneosHealth.com.