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Dispelling the Myths About Clinical Standardization

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This 90-minute webinar will examine the many myths that get in the way of clinical standards adoption and demonstrate how complying with required standards benefits both the FDA and sponsors.

Speaker
Instructor: Kit Howard
Product ID: 702494

Why Should You Attend:

Within the next 4 to 8 years, all CROs and sponsors will have to adopt clinical data standards for all studies being submitted to the FDA. While some companies have implemented standards already, many more have not. Designing and implementing the right standards the right way is a significant challenge, and to make matters worse, there are many beliefs about standards that make the task seem even more daunting than it is.

This webinar will help to dispel the myths and common misconceptions surrounding the adoption of clinical data standards and show how the broader the standards implementation across functional areas is, the greater the benefits to both FDA and sponsors.

Areas Covered in the Seminar:

Who Will Benefit:

Instructor Profile:

Kit Howard, the founder and owner of Kestrel Consultants, has almost 30 years of experience in the biopharmaceutical industry and is a recognized expert in clinical data standardization, data quality and data management. She provides consulting and training services in these topics for pharma, biotech, medical device, academic research and regulatory organizations. She has published extensively, presented at more than 50 conferences, and has recorded more than three dozen webinars.

Kit co-leads the CDISC Medical Devices Standards team, is a member of the CDISC CDASH (data capture) management team, a CDISC Registered Solutions Provider and an official CDISC trainer. She is a certified clinical data manager and serves on the Society for Clinical Data Management’s Editorial Board. Kit an instructor in the School of Medicine’s Program in Public Health at Michigan State University and holds a graduate degree in Clinical Research Design and Statistical Analysis from the University of Michigan.

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Refund Policy
"Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance.
ComplianceOnline would process/provide refund only if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs."
For substitution, please email editor@complianceonline.com or call +1-650-620-3937.

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Training Options Training Duration = 90 Min
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