OverviewThis 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
- 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 attendAll 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.
Earn CEUsParticipants are eligible to receive CEUs upon attendance and successful completion of a web-based assessment within 30 days after the webinar. CEUs are not granted after the 30-day assesment deadline.
SCDM is authorized by IACET to offer 0.2 CEUs for this program.
Individual registration: $360 member / $420 non-member
Group registration (max.10 people per group): $960 member / $1140 non-member
Group Registration Policy: Any group registration allows up to 10 people to attend the webinar and to complete the webinar assessment. Credits will be granted on an individual basis upon successful completion of the assessment by the registered participants.