The focus of this webinar is how sponsors, CROs and sites can focus on quality factors at the time of trial design and prepare for these new rules.
TORONTO (PRWEB) May 17, 2021
Our industry is eager to learn what changes are included in ICH E6 (R3) Good Clinical Practice recommendations this year. Understanding how taking a risk-based, fit-for-purpose approach in the use of technology to conduct clinical trials will impact the industry’s current procedures. A key focus includes Quality Tolerance Limits (QTLs) and how clinical trial teams can identify, manage and report risks associated with Critical to Quality (CtQ) factors that answer key questions and support sound decision-making while protecting patients. The focus of this webinar is how sponsors, CROs and sites can focus on quality factors at the time of trial design and prepare for these new rules.
Register for this webinar to learn about:
- ICH E6 (R3) changes and how they affect your clinical trials
- What QTLs are, and how they can be implemented to help you avoid roadblocks in your trial
- How to identify CtQ factors and use them to create focused indicators of quality
- How to prepare your clinical development for upcoming compliance requirements
Join experts from Medidata, Brian Barnes, Senior Director, Product Development; Fiona Maini, Principal, Global Compliance and Strategy; and Josh Rochotte, Product Manager, Digital Oversight for the live webinar on Tuesday, June 8, 2021 at 10am EDT (3pm BST/UK).
For more information, or to register for this event, visit Preparing for ICH E6 (R3) Good Clinical Practice Changes.
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