More eRegulatory Experiences: Embracing a Paperless Process for Your Site
Are you frustrated with your current manual, paper process? Are you tired of chasing around staff members to obtain signatures? Have you ever wondered "There has to be a better way"?
In this webinar - presented in partnership with Clinical Conductor- you'll gain a first hand understanding of transitioning from paper to electronic binders from leading sites like OptiMed and Chesapeake Research. Learn how they overcame initial obstacles and realized their strategic goals.
After watching this webinar, you'll learn:
- How sites can better manage multi-site operations and remote teams
- How sites can overcome barriers such as Sponsor / CRO acceptence, staffing concerns, and FDA regulations
- Common misconceptions regarding 21 CFR Part 11 compliance
- How to implement a validation process for system updates
- Ways to leverage eSignatures, communication tools and drag-and-drop functionality to build in efficiencies and improve study startup
- What challenges sites faced during their transition to paperless
Access this on-demand webinar now!
Click here to access the feature article, More eRegulatory Experiences: Embracing a Paperless Process for Your Site, based on this webinar.
Dustin Caldwell, Director of Operations at OptiMed Research, LTD
Dustin studied Developmental Health at the University of Hawaii. His clinical background is primarily in emergency medicine where he worked in Honolulu at Straub Hospital and Queens Medical Center. He also spent a year in the surgery department at Stanford University Medical Center. Dustin became involved in research in 2011, when he began working in research on pediatric pulmonary disease. He joined Optimed Research in 2013. Dustin enjoys reading and the outdoors; he plays rugby for a local Columbus team.
Neal Surasky, Data Manager at Chesapeake Research
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 still serves in that capacity, with the addition of regulatory responsibility and oversight. In 2014, Neal earned his Certified Clinical Research Coordinator credentials. He and his family live in Columbia, Maryland.