How to Minimize Regulatory Risk, Increase Participant Comprehension and Reduce Costs
Informed consent has a major impact on regulatory compliance, enrollment rates and recruitment expenses across the life of your study. The traditional paper-based informed consent process has transformed it into one of the most cited regulatory deficiencies in clinical trials today.
Regulatory agencies and leading biopharmaceutical companies have been pushing for a more effective informed consent solution, an electronic solution, one which addresses the challenges of low comprehension and poor process documentation, and which delivers a better experience for trial participants and site staff alike.
In this webinar, you’ll learn about ground-breaking strides being made in the field of Electronic Informed Consent (eConsent) and how you can leverage new eConsent innovations to increase participant compliance, retention and comprehension while reducing regulatory risk and expediting consent development and approval across all stakeholders.
Presented by
Sandra “Sam†Sather,
VP, Clinical Pathways
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.
Mika Lindroos,
Director of Product Management, CRF Health
Mika Lindroos is the Director of Product Management at CRF Health, and he says he is most at home where technology meets humanity. With just over two decades in software product management in the global environment, Mika’s breadth of experience spans from product and portfolio management, strategy and business development, and heading a product line at Nokia to revenue and business relationship development at Digia Pic.
Mika is a specialist in developing and managing relationships both internal and external to his organization, as evidenced by his varied roles in team motivation, change management, as well as customer relationship development.
