Reducing the eTMF Operational Burden Using Risk-Based Approaches, New Webinar Hosted by Xtalks

Reducing the eTMF Operational Burden Using Risk-Based Approaches, New Webinar Hosted by Xtalks

Press Release ( - TORONTO - Nov 20, 2018 - Life sciences organizations from emerging biotech to tier 1 pharma face a common challenge: the number of resources needed to maintain a high-quality, inspection-ready trial master file (TMF) rises with every additional clinical study they manage. For smaller organizations, already overextended study team members often upload and QC more and more documents. Larger organizations may have dedicated in-house or contracted teams to manage TMF documents, but they face recruiting and training challenges, which can lead to increased expenditure on an ever-increasing pool of resources.

Two possible solutions to reduce this burden are automation/machine learning and the use of risk-based approaches to manage the TMF. Machine learning is a promising technology but still in its infancy for TMF processing. In contrast, risk-based approaches can be adopted today.

On Friday, Dec. 7, 2018, at 10 a.m. EST (3 p.m. GMT), join the live webinar with industry experts from IQVIA Kathie Clark, Senior Director of Offering Management, Gillian Gittens, Customer Success Manager, and Terri Baker, Associate Director, Expert Services, as they examine several risk-based approaches that can reduce the resources – and cost – of maintaining a high-quality TMF. Some of the topics to be discussed include:

  • Determining whether the burden of TMF documentation can be reduced based on the low-intervention nature of the trial
  • Using sampled QC processes rather than 100 percent QC based on users’ quality history
  • Focusing QC on checks that affect quality
  • Ranking documents based on risk to concentrate QC resources on higher-risk documents
  • Identifying study and site risk factors which may result in the need for a higher level of scrutiny
  • Using quality reviews to adjust risk assessments
  • Designing processes that avoid the need to organize, file and retain paper documents

To help viewers determine which of these strategies may be helpful, the webinar will review health authority guidance, discuss applying a risk framework and provide an overview of how technology can be used to implement risk-based approaches that will provide a measurable impact in curbing growth in resource needs and cost.

For more information about this complimentary webinar, visit Reducing the eTMF Operational Burden Using Risk-Based Approaches.


Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks, visit

For information about hosting a webinar, visit


Sarah Hand
​Tel: +1 (416) 977-6555 ext 224

Source : Xtalks
Business Info :

You may also like this  


Or using ePRNews Account

Don't have an account ? Sign Up

Register New Account

Or Signup using Email

Already have an account ? Login

Reset Password

Already have an account ? Login


If you have any concerns regarding this press release, please contact the Author / Media Contact / Business of this press release. ePRNews is not resposible for the accuracy of the news posted and do not endorse, support any product/ services/ business mentioned and hereby disclaims any content contained in this press release.