Sponsored Webcast: Avoiding Non-Compliance: Common Pitfalls in Meeting Global Trial Disclosure Rules (On Demand)

Member: $0 | Nonmember: $25
Avoiding Non-Compliance: Common Pitfalls in Meeting Global Trial Disclosure Rules. Review frequent compliance gaps and implementation challenges.

With clinical trial disclosures varying worldwide, sponsors often stumble in meeting global transparency rules. From registration and reporting timelines to data formatting and patient privacy, obligations differ across regions. Gaps can quickly occur for companies managing complex global programs despite best intentions. This session will examine common compliance pitfalls and challenges in operationalizing transparency and anticipates enforcement actions resulting from reporting delays, data inconsistencies, and process breakdowns. Attendees will gain insights into the root causes of non-compliance and proven methods to close process gaps. The focus will be on practical steps global teams can take to avoid missteps, integrate compliance checks, and ensure adherence to disclosure regulations worldwide

Learning Objectives

Review the key global regulations related to clinical trial transparency and disclosures

Recognize typical trouble areas in meeting clinical trial transparency rules globally

Understand what may trigger enforcement actions and how to avoid common pitfalls

Develop streamlined systems to ensure adherence to regional disclosure regulations

Leverage technology and tools to minimize compliance risks

Audience Learning Level

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Speaker

Thomas Wicks
Head of Transparency Operations, Citeline

Thomas Wicks is the Head of Transparency Operations at TrialScope, a Citeline company, where he coordinates TrialScope’s operations, consults on the business strategy, and leads the disclosure advisory services. He is responsible for tracking clinical disclosure and data-sharing trends that shape the company’s clinical transparency solutions and services. Thomas has over 25 years of experience with compliance management solutions, specializing in applications for life sciences with a focus on clinical trial disclosure and transparency since 2007.