Part 3: Rare Disease Clinical Development – Strategies for Ensuring Endpoint Integrity, Upcoming Webinar Hosted by Xtalks

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In this free webinar, Medpace partners with Michelle Eagle of ATOM International, a provider of CE training for clinical trials across the world, to discuss approaches and steps that can be taken to ensure quality and integrity.

Xtalks Life Science Webinars

Having a cohesive training strategy that includes conducting pre-study evaluation and training, as well as ongoing review of clinical evaluator (CE) performance and adherence to standardised procedures is an important contributor to success.

Join the live webinar on Tuesday, April 21, 2020 at 11am EDT (4pm BST/UK) with speakers Michelle Eagle, Managing Director at ATOM International Limited and Chad Leslie, Sr. Data Manager & Michelle Petersen, MS, Sr. Director, Clinical Trial Management both at Medpace.

Because clinical trial endpoints for rare diseases are often not well defined, consistency of endpoint assessments across study sites and over time are critical to ensuring data integrity. Having a cohesive training strategy that includes conducting pre-study evaluation and training, as well as ongoing review of clinical evaluator (CE) performance and adherence to standardised procedures is an important contributor to success.

For example, neuromuscular studies incorporate training of clinical evaluators at investigator meetings, support video-recording of patient assessments at study visits to review for quality control and perform periodic refresher training throughout the course of a study.

Topics will include:

  •     What does a comprehensive training program look like?
  •     How natural history data can inform endpoint selection (real-word examples)
  •     Rating assessment considerations and review (video QC and clinical assessment reliability)
  •     The role of data management – cleaning and coding of data to create structured output for review and reliability

This webinar is third in a 3-part series on rare disease clinical research:

Part 1: Rare Disease Clinical Research – Spotlight on the Patient and Caregiver

Part 2: Rare Disease Clinical Research – A Deep Dive into Regulatory Strategies & Considerations

Part 3: Rare Disease Clinical Development – Strategies for Ensuring Endpoint Integrity

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
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