Become an expert on quality and risk-management strategies and procedures. This interactive eLearning course answers the fundamental questions: What is RBM and how is it different from the standard monitoring approach?
“Coming together is a beginning. Keeping together is progress. Working together is success.” – Henry Ford. How do you build a solid sponsor-site working relationship from site identification to closeout and beyond? This session was provided at ACRP 2018 and was requested to be brought back as it was a so insightful. The speakers for this session represent the sponsor and site perspective and will engage the attendees with an interactive session designed for all site and sponsor representatives to build on their effective communication strategies.
This presentation will focus on selecting the best vendors for a specific study, including vendor costs in the study budget, and how to successfully collaborate with the vendors from startup to close out. (This session will not cover qualification of vendors.) I will review the most common types of vendors needed for clinical research studies, what information each type will request from the study sponsor, and how to develop vendor budgets. There will be a discussion on how to review vendor proposals to determine the best fit for the study. Once selected, I will review methods to ensure oversight of the vendor during the length of the study.
Expanded access to investigational drugs and devices has been available for decades through special pathways provided by the FDA. More recently, two federal actions have widened this access. 1. A federal law allowing for the “right to try” these same unapproved products has been enacted by US Lawmakers. 2. The previous rules governing expanded access have been modified to streamline the process to expedite such access. How do they differ? How should regulatory and research professional advise and/or assist patients faced with these choices? This session will provide a current and complete description of the two pathways, their advantages and challenges.
Emily Pauli, PHRMD, Director of Research at Clearview Cancer Institute (in Huntsville, AL) and Amy Schmidt, DBA, MBA, CCRC, Compliance Manager, AbbVie (Mettawa, IL) will provide the perspective of both the Sponsor and the Site regarding FMV, SOC and Subject/Travel Reimbursement in clinical study budgets. There are two vantage points to contracting and this session will allow the audience to hear from both regarding their processes and how they mirror and possibly conflict….and suggestions how to have a positive outcome for both parties.