Regulatory and technological landscapes are evolving at breakneck speed, creating both obstacles and opportunities for clinical research sites and providers. From updates to ICH E6(R3) proposed coverage in ICH E6 (R3) Annex 2 and an ever-broadening array of technology solutions from technology companies, clinical research organizations (CROs) and sponsors—staying ahead of these changes is not just about compliance—it is about survival and success.
In this webinar, the expert speakers will focus on the complexity and deliver actionable insights for site leaders, sponsors and CROs alike. They will unpack what actually matters, including:
- Which regulatory changes are legitimate considerations, which are on the horizon and which are business as usual?
- Is new technology making trials more efficient or just adding complexity (and cost)? And most importantly—where is the real opportunity?
The expert speakers will cut through the hype and get real about what is working, what is a total headache and what we all need to do to stay competitive in an industry that is always evolving.
Register for this webinar to gain expert perspectives on the latest ICH E6(R3) updates, the impact of emerging tech solutions and strategies to stay competitive in an increasingly complex industry.
Speakers
Brad Hightower, CEO, Hightower Clinical
Brad Hightower is a seasoned clinical research professional with extensive experience in leadership roles across various organizations. As the CEO of Hightower Clinical since February 2018, Brad has been instrumental in overseeing clinical research initiatives. Additionally, Brad serves as the showrunner for the Note to File Podcast and holds positions on advisory boards and web management for several health-related platforms.
Prior to these roles, Brad was the Executive Director and Clinical Research Manager at the Oklahoma Heart Hospital Research Foundation and served as a Clinical Research Program Adjunct Professor at Oklahoma City Community College. Brad’s academic background includes a Bachelor of Arts degree from the University of Oklahoma and an Associate of Science degree in Clinical Research Coordination from Oklahoma City Community College.
Edye Edens, Senior Attorney, Kulkarni Law Firm
Edye Edens is a licensed attorney with experience in international human rights, ethics, and health law. She serves as Senior Attorney at Kulkarni Law Firm. Edye previously worked at Indiana University where she worked extensively within the HRPP on grants, contracts, IRB operations, FDA clinical research compliance, and research integrity. Additionally, she was embedded in the IU Simon Comprehensive Cancer Center as the first Quality and Compliance Manager overseeing all regulatory, quality, auditing, training, and data safety management.
She regularly publishes articles and speaks at regional and national professional research and compliance association meetings, including HCCA, SCCE, PRIM&R, MAGI, AAHRPP, SPARC, RAPS, and AHLA. She is also a Certified IRB Professional (CIP), Certified Clinical Research Professional (CCRP), and holds a green belt certification in Lean Six Sigma. Edye’s academic background includes a Bachelor of Arts degree from Oklahoma State and both a Master of Arts in International Research Ethics and a Juris Doctor from Indiana University.
Michael Keens, CEO, Sabai IRB
Mike Keens is a seasoned leader with deep expertise in clinical trial operations and commercial strategy within the pharmaceutical development and services sector. Mike serves as the CEO of Sabai IRB, a leading Central Institutional Review Board and Institutional Biosafety Committee provider. Throughout his career, Mike has navigated both large CROs and niche service providers, balancing clinical trial operations with a strong focus on commercial strategy.
His leadership has earned industry-wide recognition, including being named a PharmaVoice Top 100 Most Influential Person in Pharma (Patient Advocacy) and recognized as a Top 20 Innovator in Pharma Development by CenterWatch. Mike’s academic background includes a Bachelor of Science in Biology and Psychology from James Madison University and a Master’s in Public Health from The University of Virginia. Mike also serves as a guest lecturer in the Master’s of Biotechnology programs at Georgetown University and The University of Virginia.
Who Should Attend?
This webinar will appeal to those working in the following areas or having the following job titles:
- Clinical operations
- Project Managers
- Site feasibility
- Regulatory affairs
- Site Directors
- Study Coordinator
What You Will Learn
Attendees will learn about:
- The regulatory shifts that will actually impact your site
- Technologies that are changing (or complicating) site operations
- Strategies to turn industry headaches into competitive advantages
- Expert insights on future trends and how to stay competitive
Xtalks Partner
Sabai Global
Sabai is the third largest provider of Central Institutional Review Board (IRB) and Institutional BioSafety Committee (IBC) services and reviews, and the only one in the top three with an exclusive focus on these services. With more accredited biosafety professionals than any other organization in the US, Sabai is known in the industry for its collaborative approach and delivery that leads with science and differentiates with customer service.
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