How Feasible is Feasibility in Clinical Trials?
Original Air Date: Wednesday, January 29th 2020
Time: 10 am (EST) | 7 am (PST) | 3 pm (CET)
Feasibility is often considered the process to determine if a clinical site and investigator are a good fit for a clinical trial when in fact, feasibility assessments begin long before site evaluations. With trials becoming more complex, it is vital for sponsors and CRO’s to collaborate to determine the feasibility of the trial itself. Aggressive timelines and tight budgets make trial feasibility relevant in all components of trial design and clinical strategy. Pre award feasibility assessments consider multiple factors to ensure trial success and operational efficiencies. A panel of CATO SMS experts will discuss the role of pre award feasibility assessments and challenges in order to drive clinical strategies, meet the timelines and trial endpoints in a cost efficient manner.
Webinar Key benefits for you:
- Identify key elements in clinical trial feasibility
- Incorporating feasibility assessments into the big picture
- Importance of accurate data and relevant resources
- Discuss the significance of enrollment scenarios
- Pre award feasibility versus site level feasibility
- Recognize challenges in study design and how to overcome them
- What does the future look like in feasibility and clinical strategy
About the Presenters
Adam Coleman, MSPAS, PAC
Dr. Coleman has more than 15 years of clinical practice as a Physician Assistant with experience in trauma/emergency medicine, internal medicine and sports medicine. He was a faculty member at Duke University school of Medicine where he ran the Emergency Medicine Program for Medical and PA students. He transitioned to clinical research over 5 years ago working on oncology trials in various consulting roles. From there he started a global site identification and site relations department where he and his team utilized their global feasibility capabilities to develop site and network relationships to enhance clinical trial efficiencies with innovative and strategic ideas. At CATO SMS his responsibilities include professionally disrupting the status quo, conducting clinical trial feasibility reviews, clinical strategy development, clinical and medical consulting for projects and bid defense participation while establishing site and investigator relationships.
Laura DiMichelle, Ph.D.
Senior Director, Clinical Strategy
Dr. DiMichele has more than 15 years of clinical and translational research experience. She obtained her Ph.D. in cell and molecular pathology at the University of North Carolina at Chapel Hill School of Medicine, and her work centered on mouse models of cardiac development and disease. Since joining Cato SMS, Dr. DiMichele has served as scientist, clinical study manager, project manager, and program director on numerous projects, and she has authored various types of regulatory, clinical, and scientific documents. At Cato SMS, Dr. DiMichele has many responsibilities, including writing and reviewing regulatory, clinical,and scientific documents; providing clinical trial management, pharmaceutical development, and project management; assisting with Clinical Trial Operations; preparing for and attending Food and Drug Administration meetings; providing scientific consulting; and assisting with the preparation of business development proposals.
Clinical Research Manager
Ms. Sullivan has more than 9 years’ experience in clinical research. As a clinical research manager at Cato SMS, Ms. Sullivan manages the execution of multicenter trials in various phases of development. She serves as the direct contact for the sponsor, sites, clinical research associates, and third-party vendors regarding clinical trial operations activities. Ms. Sullivan also serves as study start-up specialist for assigned trials, responsible for managing expedited study start-up activities. Ms. Sullivan has a sound knowledge of the principles of Good Clinical Practice (GCP), International Council for Harmonisation (ICH) E6 guidelines, and Food and Drug Administration regulations for investigational drugs and devices.