Streamlining IRB Submissions to Accelerate Clinical Trials, New Webinar Hosted by Xtalks

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Xtalks

Feb 04, 2019, 09:00 ET


TORONTO (PRWEB) February 04, 2019 -- Numerous factors adversely impact the initiation of clinical trials and their efficiency in an industry plagued by rising development costs and increasing complexities. Complex protocols, finding patients who meet challenging inclusion/exclusion criteria, protocol amendments, competition for sites, contract and budget negotiations, regulatory changes and global compliance, PI and CRA turnover, and IRB approvals all contribute to significant trial delays.

Before research on human subjects can begin, federal regulations require approval from an IRB. Many researchers have complained that use of multiple IRBs to review research sites for a multicenter trial is extremely inefficient and leads to additional cost burdens and trial delays.

Research indicates principal investigators spend 42 percent of their time on “administrative burden,” with IRB-related burdens ranking the highest, and a third of the time required for IRB approval due to researcher omissions and errors. IRB review takes roughly 1.4 – 2.9 percent of the total time devoted to the study and represents 2.3 – 4.7 percent of study costs.

Addressing the inefficiencies in IRB approvals is essential to reducing costs and speeding the delivery of life saving therapies to patients in need. How can a streamlined system improve and expedite human research oversight?

Join Mitchell Parrish, EVP & General Counsel at Quorum Review IRB, Barry Milton, Head of Business Operations at Novartis and Elvin Thalund, Director of Industry Strategy at Oracle Health Sciences in a live session on Tuesday, February 26, 2019 at 1pm EST to learn about:

  • Common bottlenecks and submission errors in the IRB submission process
  • The growing trend of using centralized IRBs for multisite studies
  • How the trial master file (TMF) reference model can be utilized to create a standard language for the exchange of documents for IRB submissions, approvals and notifications
  • How workflow-based technology can be integrated with IRB processes to accelerate the submission process and reduce submission errors

For more information or to register for this event, visit Streamlining IRB Submissions to Accelerate Clinical Trials.

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/

Candice Tang, Xtalks, http://www.xtalks.com, 1 (416) 977-6555, [email protected]