Faced with rapidly evolving regulatory requirements, new technologies, and demands for greater efficiency, how can regulatory teams succeed in an increasingly complex environment?
As requirements for improved inspection-readiness and quality risk management become more critical than ever, so too does the need to create seamless integration and data flow between the eTMF and CTMS in a study.
Doing so effectively brings a host of compliance, accuracy, and efficiency benefits – yet it is much easier said than done. Join us live on May 11 to pose your toughest eTMF-CTMS integration questions and challenges to our experts. From the business case for integration to common technical pitfalls to avoid, Jim and Aaron will bring their first-hand experience with these systems to this interactive discussion.
Are you looking for an easy to use and intelligent Regulatory Information Management solution?
Join Regulatory experts Jim Nichols and Aaron Grant to see how PhlexRIM 2.1 will help you work even faster and smarter, by streamlining business processes to provide a single source of global registration information.
Watch this on demand Q&A session where you can find the answers to everything TMF Reference Model related. TMF Reference Model co-founders, Karen Roy and Lisa Mulcahy will answered all live questions and provided expert guidance.
The new Clinical Trials Regulation (EU) 536/2014 has raised critical questions about business process and data interactions between Clinical and Regulatory in biopharmaceutical companies. Did you know that as of 6 March 2022, there were more than 200 draft applications in CTIS?
In this session find out what Phlexglobal are doing to share the impact and lessons learned from our clinical and regulatory experts.
For inspection-readiness, the critical attributes of TMF health are completeness, timeliness, and quality.
In this session, we explored what your TMF Health Score is and how this can be used to achieve and maintain ongoing TMF health and inspection readiness.
Bring your toughest TMF challenges to this open forum, where Karen Roy, TMF Reference Model co-founder and, Sarah Tucker will answer your questions and provide expert TMF guidance.
