...and Why Top Pharma is Turning to eConsent
Informed consent must be overseen by the investigator, sponsor, and ethics committees to ensure study participants 1) understand the study to make a voluntary decision to participate, 2) are adequately consented, and 3) are updated in a timely manner when changes occur that may impact their decision to continue participating.
The current paper process fails to support stakeholder oversight of the consent process and effectively inform the investigator, ethics committee and sponsor of regulatory and regional requirements compliance challenges.
Additionally, the current paper process does not support subject recruitment and retention. The demand for a better solution that improves the age-old problem of trial oversight to enable a better experience for all is here and the industry is being called to action.
In this webinar, you’ll learn how electronic informed consent (eConsent) can increase sponsor, ethics committee, and investigator oversight of the development, use, archiving, reconsenting, and monitoring consent process. Learn how you can improve subject comprehension and impact better data.
Understand how ethics committees, sponsors, investigators, quality assurance and monitoring teams eliminate common issues and stay informed of timely consent issues to support the participant without waiting for a site visit. Most importantly, we’ll discuss how flexibility in an eConsent system can support risk management anywhere in the world to prevent issues.
Join CRF Health and Chesapeake IRB in this critical session on how eConsent can enhance informed consent oversight and better inform participants. We look forward to seeing you at the webinar!
Presented by
Sandra “SAM†Sather,
VP, Clinical Pathways, Regulatory & Quality, TrialConsent - CRF Health
Sam's current focus of consulting is to promote clinical quality systems for sponsors/CROs, investigators, and clinical research institutions. She has over 30 years of clinical experience, a Bachelor of Science degree in Nursing and a Master of Science degree in Education with a Specialization in Training and Performance Improvement.
Sam has served many roles in clinical research, including site study coordinator and manager, sponsor and CRO monitor, quality assurance auditor, risk manager, trainer, and performance management consultant. She has held clinical research industry certifications for over 15 years by the Association for Clinical Research Professionals (ACRP). Sam is a current member of the ACRP Academy Board of Trustees and Regulatory Affairs Committee (RAC). She is a frequent subject matter expert for GCP regulation and speaker at industry conferences. Sam has authored dozens of competency-based curriculums for various clinical research stakeholders.
Lauri Carlile,
Executive Director, Chesapeake IRB
Lauri Carlile, MS, CIP is Executive Director at Chesapeake IRB. In this capacity, she oversees IRB operations, including QA/QI, compliance, client services, and AAHRPP accreditation processes. Prior to joining Chesapeake IRB, Ms. Carlile served as a QA/QI Specialist, Senior Human Research Review and Compliance Specialist, as well as an Administrative Chair for an institutional IRB for a major academic institution in Boston, MA.
She is a frequent speaker on human research protections and holds a Master of Science degree in Clinical Investigation from MGH Institute of Health Professions and a Bachelor of Science degree in Biological Sciences from the University of Maryland, Baltimore County (UMBC). She is a member of Public Responsibility in Medicine & Research (PRIM&R), Regulatory Affairs Professional Society (RAPS), Association for Clinical Research Professionals (ACRP), and is a Certified IRB professional (CIP).
Jeff Wendel,
President and CEO, Chesapeake IRB
Jeffrey Wendel is the President and CEO of Chesapeake IRB which provides independent IRB oversight domestically and internationally. He has over 20 years of executive leadership experience providing consulting and systems integration services to global 500 companies in the pharmaceutical, financial services, and high technology industries.
Prior to joining Chesapeake IRB, Mr. Wendel served as president and board member of a systems integration group that completed a successful IPO; led an international business unit focused on simulation software modeling; and established a government services division supporting US and international agencies. He led the successful integration of an acquired firm and actively participated in an international expansion effort that leveraged existing clients and partners. Mr. Wendel earned a BS in Systems Engineering from the US Naval Academy and an MBA from Loyola College. He is a retired US Navy nuclear submarine officer.
Mr. Wendel is the Chairman of the Association for the Accreditation of Human Research Protection Programs (AAHRPP) Board of Directors. He is also a member of the Board of Directors of Community Support Services (CSS) which provides work place and living assistance to individuals with developmental disabilities.
