Medidata Cloud Powers Clinical Trials of the Future

Delivered as a part of a learning series with FDA Auditors, I spoke along with my colleagues in consulting and compliance about the opportunities that using Medidata Detect as a solution could present for auditors. How AI Detection Improves Data Quality, RBQM Detection Methods and the ability to minimize the risk of undetected anomalies were showcased

How Risk Management and Quality Tolerance Limits (QTLs) Streamline the Process

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 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
• Current implementation roadblocks and methods to increase the adoption of QTLs in clinical trials
• How to identify Critical to Quality (CtQ) factors and use them to create focused indicators of quality
• How to prepare your clinical development for upcoming compliance requirements