Clinical Trial Enabling Technologies – Decentralized Clinical Trials

The Georgia Clinical & Translational Science Alliance- Georgia CTSA and Southern California Clinical and Translational Science Institute -SC-CTSI have collaborated to provide free, high quality educational programs for clinical research professionals at novice to expert levels of experience. At the completion of each course or program, participants earn contact hours recognized by a certificate and/or badge.

Description:

Decentralization of clinical trials has been a growing field enabled further by advancement in emerging technologies.  The experience of one company’s decentralized approach to administering clinical trials, main benefits of decentralization, and an outline of key considerations when planning and designing elements of a decentralized trial will be explored.

Topics:

1. Current Problems of Clinical Trials
2. Science 37’s Approach
3. NORA Transforms Trial Logistics
4. Key Regulatory Questions:
   • What are the potential advantages or benefits of conducting a study via the decentralized model (DCT) verse using a conventional brick and mortar approach?
   • Will data collected via the decentralized model be accepted by health authorities?
5. Characteristics of “Best Fit” Studies for the DCT Model

Speakers: 

Dr. Jonathan Cotliar, MD is a dual-trained and board-certified internist and dermatologist with a special interest in complex medical dermatology, including graft-versus-host disease, adverse drug reactions, and the management of cutaneous toxicities related to traditional chemotherapeutic agents as well as to targeted anticancer therapies.  He previously served as a full-time faculty physician at the David Geffen School of Medicine at UCLA, and at Northwestern University Feinberg School of Medicine before joining City of Hope National Medical Center to lead a new dermatology program there.  Jonathan joins Science 37 excited to help further build upon the success of the company in employing innovative technology to expand patient access to clinical trials.  jonathan@science37.com

Lisa DiMolfetto, PhD has almost 20 years of experience in the pharmaceutical/ biotech industry, with a focus on regulatory affairs and project management.  She has held leadership roles in these functions, most recently at Amgen, to develop and execute global drug strategies.  Lisa has worked across all stages of drug development and in numerous therapeutic areas, including cardiovascular, inflammation, neuroscience, oncology, and infectious diseases, and has led a number of transformational cross-functional initiatives and acquisition integrations.  Prior to joining industry, Lisa earned her PhD in Immunology from the University of California at Davis and a BA in English/Communications from California State University in Bakersfield.  lisa@science37.com

Learner Level: Advanced

Audience:

This symposium is designed for Clinical Research Coordinators, Project Managers, Monitors, Regulatory, Medical and Clinical Affairs Professionals or junior faculty with 3+ years of experience seeking to further develop clinical research conduct skills and principles.  Clinical research professionals should have responsibilities that include clinical trial start up planning, mentoring and complex issues involving site management, study management, and sponsor/ CRO challenges. 

Contact Hours:

Emory Nursing Professional Development Center (ENPDC) is accredited as a provider of nursing continuing professional development by the American Credentialing Center’s Commission on Accreditation. Attendees to this CNE activity will be awarded 1.0 contact hours by ENPDC. No conflict of interest has been found with the speaker for this CNE activity nor with the members of the planning committee.

Need Help with Registration? Please contact us at ene@emory.edu or 404-727-9208.

Program Information: This is the fourth course in a six (6) session program. To complete the entire program and earn a badge CLICK HERE.