The Role of the Monitor in a Risk-Based Monitoring Program

Clinical Trials, Life Sciences, Pharmaceutical, Pharmaceutical Regulation ,
  • June 12, 2014

Risk-based monitoring is no longer an innovative theory but a real-world practice—today’s life science R&D leaders are actively redefining their site monitoring programs.

But what does this mean for current on-site monitoring practices? Will monitors spend less time on source data verification (SDV) and more time on investigator and site training, source data review (SDR) and supporting recruitment efforts? Will centralized site quality management tools deliver monitors the information they need to determine which sites need more attention and which need less? And how will adaptive monitoring methods impact visit scheduling?

Join us for this complimentary webinar to learn:

  • Industry-wide monitoring trends, from the annual monitorforhire.com survey
  • How monitors spend their time on-site to support activities like recruitment and training
  • A methodology for triggered monitoring visit schedules

Speakers

Scott Freedman, President, Founder, monitorforhire.com

Scott is President and Founder at monitorforhire.com. He brings over 28 years of industry experience to his role as President of monitorforhire.com. Prior to founding Monitorforhire he served as Executive Director of Business Development for Quintiles. Scott has had global product marketing responsibility at Centeon LLC (now CSL Behring) and also product in-licensing and portfolio planning for Bayer Biologics Division. Scott has held clinical monitoring positions with Ayerst Laboratories, Wyeth-Ayerst, Sanofi Pharmaceuticals, and in Regulatory Affairs as a QA Auditor with Bayer Corporation. Scott received his undergraduate degree in Biology from the University of Delaware and MBA in Accounting and Finance from the University of Connecticut.

Marcus Thornton, Senior Director, CTMS, Medidata Solutions

Marcus is Senior Director of CTMS at Medidata Solutions. Marcus came to Medidata Solutions with over two decades of experience in the life science industry and currently serves as senior director, CTMS. Marcus has dedicated his career to creating efficiencies in the clinical trial process. He worked at two biotechnology companies in the 1990’s and established a life sciences communications company working with Large Pharma, which he merged with an international e-solutions consultancy in Europe. Most recently, Marcus co-founded Clinical Force, innovating the development of clinical trial management systems.

Who Should Attend?

Clinical operations and data management professionals from pharmaceutical, biotechnology, and medical device companies as well as contract research organizations (CROs)

Xtalks Partners

Medidata

Medidata Solutions is the leading global provider of cloud-based solutions for clinical research in life sciences, transforming clinical development through its advanced applications and intelligent data analytics. The Medidata Clinical Cloud™ brings new levels of productivity and quality to the clinical testing of promising medical treatments, from study design and planning through execution, management and reporting. We are committed to advancing the competitive and scientific goals of our global customers, which include over 90% of the top 25 global Pharmaceutical companies; innovative biotech, diagnostic and device firms; leading academic medical centers; and contract research organizations.

Media Partners

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