Selecting and Implementing Electronic Data Capture (EDC1) Webinar

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Eeny, meeny, miny,mo — How to pick that EDC?

May 7, 2019

08:00 AM EDT AND 11:00 AM EDT

OVERVIEW

This webinar will examine the foundational considerations for selecting an EDC application; identifying the organization’s business needs, implementation timelines, application features and requirements for validation activities.  Planning for a new application and the documentation preparation required will also be discussed as well as clarification surrounding the Request for Information/Request for Proposal activities.

WHAT YOU’LL LEARN

  • List the business requirements necessary to identify EDC Vendor platforms with appropriate features;
  • Discuss the different methods of EDC software delivery;
  • Review the Request for Information (RFI) and Request for Proposal (RFP) processes in choosing an EDC Vendor;
  • Examine the Software Development Lifecycle components; and
  • Identify the Risk-based approach to validation

BENEFITS

  • Fuller understanding of the identification of business requirements for EDC applications
  • Utilization of RFI/RFP templates in exploring new applications
  • Ability to describe the Software Development Life Cycle (SDLC)

WHO SHOULD ATTEND

All levels of CDMs may benefit from this webinar.

MEET THE INSTRUCTOR

Denise Redkar-Brown is the Principal at Sunburst Clinical Solutions dedicated to consultation in the area of Clinical Data Management training and auditing capabilities. Her last assignment in the corporate area was as Director of Scientific Affairs, Data Management at Cetero Research in Fargo, North Dakota. She is also a frequent contributor to the GCDMP and chairs SCDM’s sub-taskforce on Electronic Learning. Denise began her career as a Medical Technologist working in a hospital laboratory environment. She made the transition to the pharmaceutical industry, and after more than 20 years, she has held positions in basic and clinical research. She is published in the European Journal of Pharmacology for her work in Pharmacology while at AstraZeneca and contributed to the successful submission for Accolate®, the first leukotriene antagonist for asthma therapy as well as other drugs and vaccines. Her latest publication was in the Good Clinical Practices journal (GCPj) in 2008 describing the evolving role of Clinical Data Managers.

WEBINAR REGISTRATION

$360 members/$420 non-members
Refund Policy: Participants will receive a full refund if notice is provided in writing via post or email one week prior to the course start date. If cancellation occurs by the end of week one of the course, students will be allowed to apply 50% of the course fee to the next offering of the same course. No refunds will be offered after that time.