Dismantling Data Silos to Improve Study Startup and Mitigate Risk, New Webinar Hosted by Xtalks
The focus on technology as a driver of performance improvement in clinical trials is intense, but despite years of valiant efforts, study execution remains far from optimal - for study startup, the data are dismal
TORONTO, May 8, 2018 (Newswire.com) - While technology remains critical as emphasis shifts to process optimization, it may be only part of the solution. Point solutions can hinder the flow of data across the continuum, causing already entrenched silos to dig in further. To improve performance quality in study startup, two factors are needed: an end-to-end solution and support from top management.
Unfortunately, entrenched silos such as site identification, clinical development, data management, contracting and regulatory affairs have long stymied these data flow efforts because they often have minimal understanding of what is needed downstream.
In this live webinar on Tuesday, May 22, 2018, at 1 p.m. EDT, featured speakers Eldin Rammell, managing director and principal consultant at Rammell Consulting Limited, and Elvin Thalund, senior director of product strategy at goBalto, will explore:
- How automated workflows encourage upfront planning and downstream improvements in the eTMF
- Why an upfront emphasis on quality in study startup is essential, including what factors to consider in order to mitigate risk (e.g., Which countries will be used? Which sites/investigators will be used? Which artifacts need to be identified and structured? etc.)
- How the International Conference on Harmonization ICH-GCP E6(R2) guideline defines Quality Management and builds on the foundation of regulatory documents released by the EMA and FDA
- Why breaking down organizational silos is critical to reducing quality issues
- Why management direction is critical in efforts to jump-start overall performance optimization
This webinar is applicable to:
- Sponsor and CRO roles responsible for site identification, feasibility assessment, selection and activation
- Sponsor and CRO roles responsible for collecting and evaluating trial metrics
For more information about this complimentary event, visit Dismantling Data Silos to Improve Study Startup and Mitigate Risk.
ABOUT XTALKS
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 and 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 http://xtalks.com.
For information about hosting a webinar, visit http://xtalks.com/why-host-a-webinar/.
Contact:
Nima Rajan
Tel: +1 (416) 977-6555 ext 352
Email: nrajan@xtalks.com
Source: Xtalks
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