Signed, Sealed, Delivered: Streamlining Regulatory Processes with eSignatures
Presented by: Jeremy Rigby, MBA, Neal Surasky, CCRC & Lisa Bozza Archer
There are many research documents, forms, and agreements that require signature. But when time is spent compiling paperwork and chasing down signatures, Physicians and Coordinators lose precious time. In this webinar, two leading research sites share their experience and process on adopting eSignatures to regulatory processes to save time and eliminate the need to print and manually route forms and documents.
Watch this webinar to hear answers to these common questions:
- What are the eSignature adoption trends in clinical research?
- What does Part 11 say about e-signatures and how do we comply?
- Are clinical research sites already using e-signatures and how?
- What are some best practices and lessons learned for getting staff, PI's, and monitors to accept eSignatures?
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Jeremy Rigby, MBA, President of Advanced Clinical Research
Jeremy has experience working in small pharma, global CROs, and clinical research site businesses. He currently runs Advanced Clinical Research, a network of 8 clinical research sites in Utah and Idaho. His business expertise includes entrepreneurship, operations, business development, and marketing. His clinical experience includes managing clinical trials, assembly and submission of New Drug Applications, study protocol development, study site selection and monitoring, managing clinical investigator site audits, representing sponsors and sites in negotiating study budgets and contracts, and managing CRA teams. Jeremy received a Bachelor of Arts degree from Brigham Young University and a Master of Business Administration from Duke University, Fuqua School of Business
Neal Surasky, CCRC, Director of Compliance at Chesapeake Research Group, LLC
Neal obtained his certification as a Licensed Practical Nurse in 1995 after studying at St. Philip’s College in San Antonio, Texas. He worked in a variety of settings as an LPN for 9 years, when he decided to make a change to clinical research. He started in a small Phase 1 unit, doing predominantly bioequivalence studies, but the research bug had bitten. He immersed himself in learning as much as possible about the industry, and became the supervisor of clinical operations. A short time later, Neal made the move to Chesapeake Research Group in 2005. As one of two primary coordinators, he oversaw many studies, with a focus on analgesics. As he continued to learn and develop, he became the Data Manager for the company, responsible for all data entry and quality assurance. He was recently awarded the title of Director of Compliance, overseeing both internal and regulatory compliance. In 2014, Neal earned his credentials as a Certified Clinical Research Coordinator. He and his family live in Columbia, Maryland.
Lisa Bozza Archer, Customer Success Manager at Complion, Inc.
As a former Clinical Research Associate with one of the largest CROs, Lisa obtained a strong foundation in clinical research and therapeutic areas ranging from Neurology, Rheumatology, Endocrinology to Oncology. She also gained additional exposure to site operations while working in the Compliance Office of an Academic Medical Center, where she helped support investigators with regulatory and research tasks. These experiences provide her keen insight, both to the needs and the daily experiences of Complion's clients.
As an Account Manager of Complion's Customer Success Team, Lisa regularly engages with clients to promote successful adoption and utilization of the Complion System. She actively educates and promotes awareness of Complion’s solution to clients and the research community. She also enthusiastically advocates for sites by leading Complion's initiative to provide free educational webinars to the research community. Lisa shares the Complion team’s intrinsic motivation to reduce the burden on research sites, while increasing efficiency and compliance throughout the industry.