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Explore new areas, check off those must-ask questions, and join our Phlexglobal experts together with industry leaders to discuss innovative clinical and regulatory topics. 

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Introducing our Elevate program of events for 2022

The program includes interactive sessions with multiple opportunities for engagement.
Participants are invited to register for all sessions that are of interest to you. 

 

Register Today

Clinical Trials and TMF 101 Learning Series Q&A

Wednesday October 19th 2022  

10AM ET/ 3PM BST/ 4PM CET

On September 14th our TMF guru, Rob Jones, kicked off the “Clinical Trials and TMF 101 Learning Series” with a live webinar covering clinical trial basics.  If you missed this webinar you can watch it on demand here.

 Following this webinar, Rob is taking us on an insightful journey to the essence of clinical trials and the key role played by the Trial Master File with a series of blogs.

 The first blog has now been released and you can read it here

 A new blog will be published each week over the next month and we will wrap up with a live “Ask An Expert” session on October 19 where Rob and other Phlexglobal experts will take on audience questions. 

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Elevate 2022 Events Available On Demand

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Clinical Trials and TMF 101 Learning Series

Wednesday September 14th  
10AM ET/ 3PM BST/ 4PM CET

The “Clinical Trials and TMF 101 Learning Series” kicks off on September 14 with a live webinar covering clinical trial basics.

Our goal is to spark a deeper and broader understanding of this weird and wonderful world of Drug Development, Clinical Trials, the Trial Master File, Regulations and much more – for the industry novice as well as the guru.  

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TMF Reference Model Q&A

Following on from recent changes to the TMF Reference Model Group join this session where you can find the answers to everything TMF Reference Model related.  TMF Reference Model co-founders, Karen Roy and Lisa Mulcahy will answer all live questions and provided expert guidance.

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Regulatory Roundtable_15JUNE2022_OnDemand

How Standardized Terminology Can Accelerate Global Regulatory Performance

Faced with rapidly evolving regulatory requirements, new technologies, and demands for greater efficiency, how can regulatory teams succeed in an increasingly complex environment? 

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Session 3_Elevate_Integrating Your eTMF and CTMS_11MAY2022

Examining the "Why" and "How" of Integrating Your eTMF and CTMS

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. 

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Elevate Webinar Promo Card_PhlexRIM2.1_On Demand_20APR2022

The Next Phase of Intelligent Regulatory Business Process Automation is Here

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. 

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TMF Reference Model Q&A

 

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 answered all live questions and provided expert guidance.

 

Watch On Demand

Elevate_CTIS Survey Launch_On Demand

Benchmarking Survey Launch: Are EU CTR and CTIS driving tighter Clinical & Regulatory integration?

 

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.

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Do You Know Your TMF Health Score?

 

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. 


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Session 1_Elevate_Ask An Expert_Promo Card_How to Ensure TMF Inspection Readiness-1

How to Ensure TMF Inspection Readiness & Compliance for a Recently Acquired Product

 

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.

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