Dismantling Data Silos to Improve Study Startup and Mitigate Risk, Upcoming Webinar Hosted by Xtalks

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Experts discuss how automated workflows in clinical trials encourage upfront planning and downstream improvements in the electronic Trial Master File (eTMF).

Xtalks Life Science Webinars

Unfortunately, entrenched silos such as site identification, clinical development, data management, contracting and regulatory affairs have long stymied these data flow efforts because these departments often have minimal understanding of what is needed downstream.

Join the live webinar on Tuesday, March 31, 2020 at 1pm EDT with guest speakers Eldin Rammell, Director, Expert Solutions at Phlexglobal and Elvin Thalund, Director, Industry Strategy at Oracle Health Sciences.

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.

As emphasis shifts towards 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 these departments often have minimal understanding of what is needed downstream.

Participants will also learn:

  • 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?)
  • 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 European Medicines Agency (EMA) and US Food and Drug Administration (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

For more information or to register for this 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 & 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/

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Mira Nabulsi
Xtalks
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