Streamlining IRB Submissions to Accelerate Clinical Trials

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 institutional review board (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% 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% of the total time devoted to the study and represents 2.3% – 4.7% 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?

In this webinar, featured speakers will explore:

• 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

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 trial documentation
• Sponsor and CRO roles responsible for project management of studies and operational excellence

Speakers

Mitchell Parrish, EVP & General Counsel, Quorum Review IRB

Mitchell Parrish, JD, RAC, CIP, leads the IRB, Legal, and Regulatory teams at Quorum Review, ensuring the delivery of service-centered independent ethics and regulatory reviews. His career has focused on solving pressing issues impacting innovative medical research, digital health, and software designed to support clinical research. Mitchell’s experience includes serving as an organizational leader for Kinetiq, the consulting and technology division of Quorum Review, a consultant to the National Cancer Institute, regulatory counsel to a large central IRB, and an associate attorney at the global law firm K&L Gates. He frequently speaks and writes on FDA, clinical trial, and technology topics and is Faculty for the Regulatory Affairs Professionals Society (RAPS), a Steering Committee Member for Harvard’s Multi-Regional Clinical Trials Center (MRCT), and on the Board of Directors for Life Science Washington.

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Barry Milton, Head of Business Operations, Novartis

Barry is a clinical trial and operations management expert. His experiences as an Oncology nurse, clinical trial coordinator and his senior management roles at Novartis, Roche, Merck, and AstraZeneca provides him with a well-rounded set of skills and experiences in the clinical trial space. His passion is transforming study management and trial execution processes through the creation of optimized business processes, which are supported by facilitating systems, which allow sponsor and investigator teams to meet their patient and clinical program goals faster and more efficiently.

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Elvin Thalund, Director, Industry Strategy, Oracle Health Sciences

Elvin is a recognized industry expert in clinical trials, having over twenty years of experience working as a Clinical Business Analyst Consultant at major pharmaceutical companies including, Hoffmann-La Roche and Johnson & Johnson. Elvin works as a product strategist and system architect in goBalto’s effort to optimize Study Startup. Elvin is the co-chair on the TMF Reference Model Exchange Mechanism and holds a Master of Science in Industrial Engineering from Aalborg Universitet.

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