Patient consent is one of the most important parts of clinical trials, yet is consistently the number three critical finding from regulatory inspections resulting in an FDA Form 483. Why is this? Traditional patient consent is a time-consuming and inconsistent process that places additional demands on valuable site staff. It can be confusing and intimidating for patients who, as a result, are poorly informed and reluctant to ask important questions. This results in high consent withdrawal and patient dropout, which are expensive and can introduce trial delays.

The first presentation from Jacqueline Mardell, vice president of Clinical Operations at Ascendis Pharma Inc., draws from her extensive experience in patient consent and will examine how traditional consent is managed. The presentation will advise on simple steps that can be taken to make significant improvements.

The second presentation from Neil Vivian, senior director of Business Solutions at OmniComm Systems, will explore how technology can be used to provide an eConsent process to facilitate further improvements. This presentation will include a demonstration using an Electronic Data Capture (EDC) solution to provide a framework for eConsent. He will show how eConsent contributes to reduced demand on sites, improved consistency, better-informed patients and reduced patient dropout. Barriers to adoption of eConsent will also be considered.

Through this webinar, the speakers will demonstrate how to:

Improve patient understanding
Test and reinforce participant comprehension
Provide feedback on how consent materials could be improved
Improve the patient recruitment process and reduce dropout rates
Enable process efficiencies
Reduce site workload
Improve consistency by reducing compliance issues

Keywords:

Speakers

Jacquie Mardell, VP, Clinical Operations, Ascendis Pharma

Jacquie Mardell has over 35 years of pharmaceutical and biotech industry and education experience. She has a broad background in planning, implementing, monitoring and analyzing clinical development programs; has built clinical operations organizations and led teams in the execution of clinical programs in a wide variety of therapeutic areas in industrialized and emerging countries; and has contributed to several successful product registrations. For 15 years she taught the Good Clinical Practice and elective courses at the University of California, Santa Cruz certificate program on clinical trial design and management, and she is a regular columnist for ClinicalTrialsArena.com.

Message Presenter

Neil Vivian, Senior Director of Business Solutions, OmniComm Systems, Inc.

Neil Vivian joined OmniComm in 2009 as senior director of Business Solutions and product manager. He is responsible for providing technical support to the Business Development group’s strategy of positioning OmniComm applications and services to potential and existing clients. As product manager, his responsibilities include providing guidance and insights about high-level business requirements for new product features. His role at OmniComm is based on his industry experience and understanding of new regulatory guidance related to risk-based monitoring, eSource and other areas. Prior to joining OmniComm, he was vice president of Technology Solutions at ERT, where he assisted in the development of ERT’s long-term architecture and product integration strategy.

He has worked closely with the sales and marketing group and developers to build a solid line of integrated products, using his technical background and understanding of the pharmaceutical industry and drug development. He has more than 38 years of experience in the software industry, including 24 years focused on the life sciences, built from a solid foundation in the defense industry.

He has a BSc in Physics and Engineering Science and MSc in Information Technology.

Message Presenter

Who Should Attend?

This webinar will appeal to individuals working the following or related departments:

Clinical Operations
Compliance
Regulatory Affairs
IRB

What You Will Learn

Join this live webinar to learn how to:

Improve patient understanding
Test and reinforce participant comprehension
Provide feedback on how consent materials could be improved
Improve the patient recruitment process and reduce dropout rates
Enable process efficiencies
Reduce site workload
Improve consistency by reducing compliance issues

Xtalks Partners

OmniComm

OmniComm Systems, Inc. is a leading strategic software solutions provider to the life sciences industry. OmniComm is dedicated to helping the world’s pharmaceutical, biotechnology, contract research organizations, diagnostic and device firms, and academic medical centers maximize the value of their clinical research investments. Through the use of innovative and progressive technologies, these organizations drive efficiency in clinical development, better manage their risks, ensure regulatory compliance and manage their clinical operations performance. With an extensive global experience from more than 6,000 clinical trials, OmniComm provides comprehensive solutions for clinical research. Please visit www.omnicomm.com for more information.

Ascendis Pharma

Ascendis Pharma is applying its innovative TransCon technology, which combines the benefits of prodrug and sustained-release technologies, to develop a pipeline of best‐in‐class therapeutics that address significant unmet medical needs. The TransCon technology can be applied to existing drug therapies, including proteins, peptides and small molecules, to create prodrugs that provide for the predictable and sustained release of an unmodified parent drug. In addition to our current pipeline of three rare disease endocrinology candidates, we have established oncology as our second therapeutic area of focus.