Reducing the eTMF Operational Burden Using Risk-Based Approaches

Life Sciences, Clinical Trials, Pharmaceutical Regulation, Pharmaceutical,
  • Friday, December 07, 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.

In this webinar, the speakers will 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% 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.


Kathie Clark - Senior Director, Offering Management, IQVIA Technologies

Kathie oversees the development of IQVIA’s regulated content management products, including the Wingspan eTMF. She provides thought leadership for the industry and is the author of many white papers, journal articles and blog posts on eTMF and regulatory topics, and is a member of the TMF Reference Model steering committee. She has over 20 years of experience in regulated content management for the life sciences and has worked with over 80 life sciences companies in the US, Europe, Japan and Israel.  Prior to joining Wingspan, Kathie served as Director of Product Management at NextDocs and Director of Professional Services at GlobalSubmit.

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Gillian Gittens – Customer Success Manager, IQVIA Technologies

Gillian is responsible for accelerating value for IQVIA content management customers and ensuring an exceptional experience while driving retention and growth for the business. Gillian works with customers to develop and redefine business processes to align with the implementation and use of Wingspan-developed applications. With over 20 years of TMF and eTMF experience in operations, project management, business development and marketing, across a wealth of systems and companies, Gillian has worked with the TMF Reference Model since its inception including a spinoff initiative on paper destruction. She has presented at conferences, written articles and authored whitepapers as a TMF SME.

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Terri Baker - Associate Director, Expert Services, IQVIA Technologies

As the Director of Expert Services, Terri and her team provide resources to assist with the maintenance, operations, and ongoing support of client eTMFs and eArchives.  The Expert Services team also support clients in the manual migration of data to Wingspan’s eTMF, eArchive, and eReg applications.  Previously, as the Director of Professional Services, Terri led the BA team in the elicitation and documentation of requirements (functional and user) and associated business processes for internal Wingspan projects.  Additionally, Terri is a Wingspan Project Manager for eTMF implementations at client sites.  She has over 10 years experience in Life Sciences, with a particular focus in the pharmaceutical industry.

Terri graduated from Washington University in St. Louis with a BS in Biomedical Engineering.  She also has an MBA with a concentration in Pharmaceutical Management from the Fox School of Business at Temple University.  Terri also maintains a professional association with the IBBA – The International Institute of Business Analysis.

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Who Should Attend?

VPs/Directors/Heads of:

  • IT/Records Management
  • Clinical Documentation Management
  • Clinical IT Operations
  • Clinical Operations
  • Clinical Quality
  • TMF Operations
  • TMF Owner

This webinar will benefit those working in the following industries:

  • Pharmaceutical
  • Biopharmaceutical / Biologics
  • Biotechnology
  • Medical Device Companies
  • Device, Diagnostic, or Equipment
  • Information Technology
  • Trial / Site Management



What You Will Learn

Join this webinar for:

  • A review of health authority guidance on TMF documentation
  • A discussion of applying a risk framework
  • An overview of how technology can be used to implement risk-based approaches

Xtalks Partner


Wingspan, an IQVIA company, is a provider of cloud-based Electronic Content Management (ECM) solutions and support services specifically designed for Life Sciences. Wingspan ECM solutions are developed to manage the creation, review, approval, and dissemination of regulated content managed by Life Sciences companies. Solutions are delivered on a high-performance, secure, scalable, and validated cloud environment designed to meet the end-to-end needs of our clients.

The Wingspan eTMF is an industry-leading solution used by sponsors and CROs of all sizes to manage trial master files from planning through archive. The Wingspan eTMF provides streamlined processes for uploading and QC, tools to support and measure efficiency of eTMF processes, and the transparency needed to achieve ongoing inspection readiness with Health Authorities.

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