Part 2: Risk-based Quality Management Video (RBQM) Series
While patient safety remains the primary concern of guidance ICH E6, revision 3 further directs sponsors to include patients in the research process. In part two of our RBQM video series, Amy Kissam-Sands and Tim Audin, Senior Director, Global Biometrics Group Lead talk with Taren Grom, Editor, PharmaVOICE about how to implement a proactive risk-management approach and address patient input in study design.
Related Insights
Report
New Medicines, Novel Insights: Advancing rare disease drug development
May 22, 2023
Report
New Medicines, Novel Insights: Accelerating development of cell and gene therapies
May 22, 2023
Report
New Medicines, Novel Insights: Achieving patient-guided drug development
Oct 30, 2023
Blog
Breaking through complex regulations and science speak – thinking “patients first” in lay language summary development
Jun 22, 2021
Article
Three ways to work with the FDA for better patient-focused trials
Jul 29, 2021
Article
Decentralized trial tools and technologies are here to stay: A regulatory perspective
Jul 23, 2021
Video
How to transition existing trials under EU-CTR
Feb 1, 2023
Blog
A patient-centric approach to managing clinical trial complexity
Jul 13, 2021
Blog
Including patients in DCT design
Sep 13, 2022
Article
How a joined-up development strategy pays off for early-stage biotechs
May 19, 2021
Article
Part 1 - Preparing for a Risk-Based Future: What ICH Revisions Mean for Clinical Trial Design and Conduct
Sep 14, 2021
Blog
Decentralized Trials: Considerations for Building a New Patient-Centric Model
May 13, 2021
Related Insights
Report
New Medicines, Novel Insights: Advancing rare disease drug development
May 22, 2023
Report
New Medicines, Novel Insights: Accelerating development of cell and gene therapies
May 22, 2023
Report
New Medicines, Novel Insights: Achieving patient-guided drug development
Oct 30, 2023
Blog
Breaking through complex regulations and science speak – thinking “patients first” in lay language summary development
Jun 22, 2021
Article
Three ways to work with the FDA for better patient-focused trials
Jul 29, 2021
Article
Decentralized trial tools and technologies are here to stay: A regulatory perspective
Jul 23, 2021
Video
How to transition existing trials under EU-CTR
Feb 1, 2023
Blog
A patient-centric approach to managing clinical trial complexity
Jul 13, 2021
Blog
Including patients in DCT design
Sep 13, 2022
Article
How a joined-up development strategy pays off for early-stage biotechs
May 19, 2021
Article
Part 1 - Preparing for a Risk-Based Future: What ICH Revisions Mean for Clinical Trial Design and Conduct
Sep 14, 2021
Blog
Decentralized Trials: Considerations for Building a New Patient-Centric Model
May 13, 2021