Regulatory authorities, such as the FDA, aim to assure the safety and efficacy of drugs, biological products and medical devices by overseeing all aspects of a clinical trial lifecycle.
Sufficient thought in the trial planning stage reduces time required in developing later submissions and responding to enquiries from regulatory authorities at the trial submission stage. Constant monitoring and addressing protocol issues as they occur also reduces time and issues at study completion.
Are you working with a partner with the expertise and technological resources to assist with this process and help the process go as smoothly as possible?
Tune in live on Thursday, May 28th, 2015 11:30 am ET to learn:
- Common statistical issues (during trial planning, conduct, analysis and submission phases)
- Case study examples of common issues
- Recommended approach to address common issues to regulatory authority’s satisfaction
- Enabling technology
Ron Marks, PhD
Chief Scientific Officer, Director of Biostatistics, Co-Founder, Clinipace Worldwide
Ron is a skilled, knowledgeable biostatistician and biomedical researcher, having served on the University of Florida faculty for 30 years in the Division of Biostatistics. In 2004, he retired from the university, and now devotes his time fully to building Clinipace Worldwide and assisting in product design, trial execution and customer support. He has an extensive background in design, analysis and reporting of large-scale clinical trials and other research studies, and has been a lead clinical trial consultant with a number of large pharmaceutical companies including Unilever, Braun, Procter & Gamble and GSK.
Scott Miller, PhD
Biostatistician, Clinipace Worldwide
As a biostatistician with Clinipace, Scott works on trials ranging from Phase 1 to 4, providing statistical input into clinical trial protocols and eCRFs, writing statistical analysis plans and TFL shells, implementing statistical analyses, and interacting with the FDA in protocol submission meetings or response letters. Prior to the FDA, he spent five years at the FDA’s Center for Devices and Radiological Health; first as a statistical reviewer and then as a team leader. He was responsible for reviewing trial protocols for IDEs as well as pre-market clearance (510k) and approval (PMA) submissions for medical devices – primarily those with orthopedic and neurologic indications.
Register today to reserve your spot. Even if you can’t attend the live presentation, register anyway and we’ll send you a link to the recording! Also keep an eye out for an accompanying eBook to follow the webinar.