Clinical trial study startup processes are an area ripe for optimization. Often, the study time clock doesn’t start ticking until First Patient In (FPI), but research shows that the process to get to FPI can take seven months or longer on average.
This webinar will explore best practices for study startup with practical advice on how to reap the benefits of automating processes while increasing compliance. The featured speakers will discuss some common misconceptions around digital versus electronic signatures and provide advice on how to ensure all of those signed documents comply with US Food and Drug Administration (FDA) 21 CFR Part 11 guidance.
A speaker from Clinilabs Drug Development Corporation will share a case study on how they streamlined clinical trial startup processes, optimized their tools and cut clinical trial study startup times in half.
Simon Taylor, Global Director, Solutions Consulting, SureClinical
Simon Taylor began his career in pharma at Gilead, managing day-to-day Trial Master File (TMF) operations and site management activities, seeing multiple drugs from Clinical Trial Application (CTA) through New Drug Application (NDA) approval. Since then, he has turned his attention to clinical technology and leads SureClinical’s customer-facing product offerings.
Charity Cowley, Director of Clinical Director of Administration, Applications and Systems, Clinilabs Drug Development Corporation
Charity Cowley has over 22 years of experience in the conduct of clinical research trials, including complex first-in-human through large Phase III studies. She has specific experience in investigator site management, study startup, eTMF and Clinical Trial Management System (CTMS) management. Charity attended the University of North Dakota, majoring in Psychology, and began working as a phlebotomist at PRACS Institute, a Phase I clinical research unit while completing her undergraduate studies. After college, she accepted a full-time position at PRACS as a study manager, overseeing in-house Phase I study operations, subject enrollment and study conduct. Charity continued her clinical research career as a study coordinator at investigator sites conducting Phase II-III studies in a wide range of therapeutic areas. Having gained valuable experience in positions of progressive responsibility, Charity joined the Clinilabs Drug Development Corporation team where she currently holds the position of Director of Clinical Systems, overseeing the implementation and development of the eTMF and CTMS systems.
Catherine Schmidt, President, SterlingBio
Catherine Schmidt is a highly qualified clinical research professional leading a Contract Research Organization (CRO) which specializes in clinical project management as well as eTMF consulting. She has over 20 years of experience working in clinical trials for pharma, biotech and device companies overseeing multiple projects, teams, vendors and eTMFs.
Who Should Attend?
Senior professionals such as the following roles will enjoy this webinar:
- VP/Head, Director/Senior Director of Clinical Operations
- VP of R&D IT
- Director of Outsourcing
- Director of Vendor Management
- Director of Clinical Trials
- Director of Strategic Development
- Clinical Trial Manager/Specialist
- Clinical Data Manager
- Clinical Research Manager
- CTMS Coordinator/Manager
- Clinical Study Lead
- Clinical Trial Associate (CTA) / Clinical Research Associate (CRA)
- Quality Manager
What You Will Learn
- Learn tips from experts on how to optimize study startup processes to maximize the benefits of going digital
- Understand how the FDA’s recent guidance to move to digital signatures and forms has impacted study startup
- Learn best practices from Clinilabs’ case study how they accelerated study startup using Part 11 Adobe Digital certificate trusted signing, workflow automation and how immediate access to real-time data has enabled better decision making.
SureClinical is a premier provider of FDA and EU compliance validated health science cloud applications. Our mission is to provide unified best-in-class applications to accelerate the delivery of innovative therapies to patients globally.