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Complimentary Webinar | Critical Component to Successful TMF Management – TMF Subject Matter Expertise | 25th April 2018

Phlexglobal’s Complimentary Webinar

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Critical Component to Successful TMF Management

TMF Subject Matter Expertise

 

 

We would like to invite you to a complimentary webinar “Critical Component To Successful TMF Management – TMF Subject Matter Expertise:

Wednesday 25th April 2018
3pm GMT | 4pm CET | 10am EST

Register Here1

It is well known that incomplete, poor quality Trial Master Files may have negative commercial, regulatory and legal implications.  All risks well worth avoiding.  But what about the cost of getting it right?  What does it take to prepare for that inspection/audit…extra resources, time, travel, increased time on site or rework?  How many weeks/months does it take to close the TMF?  Shifting the TMF management paradigm from event driven TMF management to ongoing TMF management will ultimately allow for more efficient processes driving the delivery of high quality and contemporaneous TMFs in a timely manner.

This webinar will explain how establishing three key roles within your organization will facilitate the shift from reactive to proactive TMF management.
Meet the Phlexglobal Speakers 
Sharon Ames Sharon Ames | Director, Client Solutions | Phlexglobal
Sharon Ames is Director, Client Solutions for Phlexglobal. Sharon is an industry leader in Trial Master File and electronic Trial Master File management.  With over 25 years of experience in the clinical research industry Sharon has extensive knowledge of clinical trial processes and cross functional relationships as they relate to essential document requirements during the conduct of clinical trials.   As a Registered Dietitian, Sharon began her clinical career at the Metabolic and Atherosclerosis Research Center in Cincinnati, Ohio.  In 2011 her clinical experience expanded to INC Research. During this time Sharon held many clinical leadership roles in Project Management, global Trial Master File management as well as for study/site start-up activities. Her more recent experience is with electronic Trial Master File system implementations and integrations in the vendor space.    
Janice Fletcher_Rho Janice Fletcher | Senior TMF Project Manager | Rho Inc.
Janice has over 8 years of experience in Clinical Research with a focus in regulatory document and TMF Management.  During her tenure at Rho, she has worked across multiple functional areas with exposure to both federal and commercial programs.  Most recently, Janice has supported and lead Rho through the acquisition and implementation of an eTMF.  In her role, she collaborated with operations, technology, and leadership to create a new TMF Business Process inclusive of the eTMF software implementation.  Janice has an insightful perspective on the keys to successful TMF implementation and management to ensure quality and inspection readiness. In her role as a Senior TMF Project Manager, Janice cultivates an environment of teamwork and collaboration.  With the support of an amazing core team, she continues to lead change and innovation in the area of TMF Management at Rho.
Register Here1

 


What our customers say about us...

"There are CROs that have the capability to do it, some do have the electronic systems. But there isn’t anybody I know who provides as good a solution as Phlexglobal."
Senior Director in Clinical Operations, top 20 global pharma
"Phlexglobal has experience in handling eTMF documents and has this as its core competency. It makes sense to outsource to them."
Associate Director of MRP Management, US pharma

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