CTMG President and CEO, Anton-Lewis Usala, MD , was invited to speak at the Food and Drug Law Institute’s Enforcement, Litigation & Compliance Conference on December 9, 2014 in Washington, DC. Dr. Usala spoke on issues affecting “Clinical Trial Data Integrity—The Investigative Site”.
The FDLI Enforcement, Litigation & Compliance Conference is held to examine the changes in law and regulation in the last year and predict changes in the year ahead. Attendees include attorneys, litigators, regulators, compliance experts, medical consultants, and academics.
Dr. Usala presented an innovative new clinical trial investigative site model that is transforming the way clinical trials are run, the Site Specific Research Organization model. This new approach translates a pharmaceutical Sponsor’s clinical trial protocol into discrete, measurable, steps whose completion as intended is tracked via real-time quality system review. Continuous on-site review of data quality, as it is being collected, along with site operational performance ensures that each process step is completed as intended, with complete audit trail, and within forecast timelines. He also discussed how the SSRO model enrolls order-of-magnitude more patients with superior quality data (that has been recognized by the FDA) with less expense and faster study completion.
If you would like to learn more about the SSRO model and how it can work for your study, please Contact Us.
The FDLI has been kind enough to post the session slides at the link below. Dr. Usala’s presentation starts at slide 26.