FALLS CHURCH, Va. (PRWEB) March 20, 2020
With ICH E8(R1) set to be adopted in June 2020, how one plans, designs and conducts clinical trials will look different than they do today. Be ready to implement the new guidelines.
The Revised ICH E8: A Guide to New Clinical Trial Requirements management report shows readers how to leverage the revised guidelines’ quality-by-design approaches, expanded study designs and data source considerations. With this knowledge, one can adapt, continuing to provide a quality-driven framework that leads to efficient and timely decision making, and ultimately to improved access to safe and effective drugs. This management report will:
- Explain the scope and general principles of the ICH E8(R1) guideline
- Describe the impact on current research practices that could influence SOPs, procedures, processes and documentation
- Describe the framework and approaches for identifying critical-to-quality factors
- Identify clinical development areas that may be impacted by the adoption of the ICH E8(R1) guideline and approaches for compliance
Prepare for ICH E8(R1) now, June is only a few months away.
Management Report Details:
The Revised ICH E8:
A Guide to New Clinical Trial Requirements
A CenterWatch Book
Management Report PDF:
Easy Ways to Order:
By phone: 888.838.5578 or 703.538.7600
Founded in 1994, CenterWatch is a trusted source and global destination for clinical trials information for both professionals and patients. CenterWatch provides proprietary data and information analysis on clinical trials through a variety of newsletters, books, databases, and information services used by pharmaceutical and biotechnology companies, CROs, SMOs, and investigative sites involved in the management and conduct of clinical trials. As a pioneer in publishing clinical trials information, CenterWatch was the first Internet site to publish detailed information about active clinical trials that could be accessed by patients and their advocates.