SOURCE: Xtalks

Xtalks Webinars

October 17, 2016 07:30 ET

ICH E6(R2) Benchmark Survey: Essential Elements of Compliant CRO Oversight, New Webinar Hosted by Xtalks

TORONTO, ON--(Marketwired - October 17, 2016) - In this presentation, Bruno Gagnon, B Pharm, MSc, Clinical Intelligence Expert and Matt McKinney, Clinical Intelligence Expert, Comprehend Systems will showcase the results of Comprehend's 2016 ClinOps ICH E6(R2) survey and its impact on the CRO/Sponsor relationship. The live broadcast will take place on Thursday, October 27, 2016 at 2pm EDT.

In Comprehend's previous 2016 survey of 300 global ClinOps leaders, 81% noted that meeting their milestones was their number one priority. Yet, only 22% respondents were confident that their CRO will achieve milestones on time and 92% stated it was due to the inability to investigate in real time.

In Comprehend's subsequent survey, they benchmarked the essential elements of a compliant ICH E6 (R2) CRO Oversight program. The speakers will present results from questions such as:

  • What are your plans for training and implementation of ICH E6(R2)?
  • What are key elements of your CRO Quality Agreements and Oversight Plans?
  • Which technologies ensure real time investigations with your CROs?
  • What Quality Risk Management initiatives are you funding?

The 2016 ClinOps ICH E6 (R2) survey put the spotlight on CRO Oversight and the need for real time investigation, decision-making and collaboration. ICH E6 (R2) is meant to encourage more efficient approaches to clinical trial design, conduct, oversight, recording and reporting. It also updates standards regarding electronic records and essential documents. The new guidance specifically highlights the need for Sponsors to ensure CROs are accountable for all responsibilities transferred to them. Comprehend's 2016 ClinOps ICH E6 (R2) survey will give insight into your peers' preparedness and how they are closing the gap.

To learn more about this complimentary event visit: ICH E6(R2) Benchmark Survey: Essential Elements of Compliant CRO Oversight

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech 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.

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