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Sites NOW

Evolving Best Practices for Site Success.

Regulatory Trends and Audit Preparedness

Tuesday, July 27, 2021 11:30am - 12:45pm EDT  
Host: Sites NOW
By: James Riddle, Vice President, Research Services & Strategic Consulting, Advarra; Henry Kravchenko, CEO, Clinical.ly; and Denise Snyder, MS, RD, LDN, Associate Dean for Clinical Research, Duke University School of Medicine

Join Sites NOW for a fresh look on regulatory trends impacting the clinical research industry.  Discover best practices for audit preparedness and how experienced sites are managing the impact of new SOPs and digital changes overtime.

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Presenters

James  Riddle
James Riddle

Vice President, Research Services & Strategic Consulting, Advarra

James Riddle is the Vice President Research Services & Strategic Consulting for Advarra where he employs his extensive experiences managing large research operations, technology, and research compliance teams to support our client’s research programs and grow Advarra worldwide.


In addition to leading Advarra’s Biosafety Service, GPStm Service, and strategic consulting teams; Mr. Riddle also serves on the Board of the Northwest Association for Biomedical Research (NWABR); as Chair of the Site Accreditation and Standards Initiative (SASI) Accreditation Council; as member of the CTTI and MRCT Steering Committees; as editorial board member for IRB Advisor; as well as a faculty member, mentor, and regular speaker for Public Responsibility in Medicine and Research (PRIM&R).


Prior to joining Advarra, Mr. Riddle served as a leader of the human subject protection and animal care and use program at the Fred Hutchinson Cancer Research Center, one of the nation’s largest independent cancer research centers. In addition, he has previously served as an AAHRPP site visitor and was the Vice President of Operations and Director of Technology at another large central IRB. His expertise includes multi-national research operations and compliance, implementation of research technology solutions, computer software validation, and management of large IRB, IACUC, and IBC systems.


Mr. Riddle has a bachelor’s degree in accounting with an emphasis in computer science from Western Washington University, College of Business and Economics.
  


Henry Kravchenko
Henry Kravchenko

CEO, Clinical.ly

Henry Kravchenko founded Clinical.ly in 2019 with the mission to provide clinical trial software that puts you in control. Clinical.ly aims to bring the latest advancements in intuitive, web-based solutions to clinical research sites, thereby enabling them to improve operational efficiencies and better serve patients and sponsors. Clinical.lys' approach is to partner with sites to help illuminate the most pressing challenges in research and offer technology solutions. Furthermore, Clinical.ly leverages its site-centric approach by incorporating feedback from many sites into every solution it delivers. This holistic approach, combined with Clinical.ly's deep technology expertise, helps ensure that Clinical.ly's solutions truly address the needs of research sites.

Prior to founding Clinical.ly, Henry spent over two decades working with Hedge Funds. He led technology teams responsible for high-tech solutions ranging from risk analytics, regulatory reporting, and large-scale trading systems. Henry holds a Microsoft Certified System Engineer Certification and Chartered Alternative Investment Analyst Designation. Henry graduated from Brooklyn College, where he earned a B.S. in Computer Information Science and holds a degree from Stanford University Graduate School of Business.


Denise Snyder, MS, RD, LDN
Denise Snyder, MS, RD, LDN

Associate Dean for Clinical Research, Duke University School of Medicine

After spending time in public health and clinical nutrition, Denise started work as a research coordinator and project manager in 2000 for NIH funded trials in oncology. In 2009, her Research Management Team in the School of Nursing received support from Duke’s CTSA to leverage the group’s services and launch REDCap for the School of Medicine. RMT became the home for the REDCap EDC implementation. For 9 years, Denise has been the Associate Dean for Clinical Research for Duke University School of Medicine. In this role, she leads the Duke Office of Clinical Research (DOCR) a support office of expertise in coverage analysis, study logistics, data management, regulatory oversight, workforce innovation and guidance for clinical research operations for Duke as a site.


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