Press Release (ePRNews.com) - 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.
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Sarah Hand Source :
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