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This course is comprised of the recorded online workshop session from the Virtual ClinBiz Summit 2020 focusing on clinical trial agreement negotiations with a special focus on site budget development and negotiation strategy from the study sponsor perspective. The video recording goes into a great level of detail on how site budgets are developed by study sponsors with various on-screen examples. The respective speaker slides are also included. For context, the online workshop session took place on September 15, 2020.
The recorded workshop session covers the following:
- Overview of clinical trial agreement site budgets and special considerations in site budget development and negotiations for study sponsors
- Standard of Care (SOC) and Fair Market Value (FMV) in investigator site budgets
- Discuss common challenges associated with site budget development and negotiations, and ways to significantly improve these
Additional topics discussed:
- Site budget negotiation parameters
- Protocol complexity
- Study design considerations
- Feasibility considerations
- Patient population
- Rate of recruitment
- Screen failure rates
- Competitive landscape
- Drop-out rate
- Study procedures
- Site level costs
- Many more topics discussed
For context, the online workshop session took place on September 15, 2020.
Primary Audience: Clinical operations, clinical development, clinical outsourcing. accounting, finance and other supporting roles within pharmaceutical and biotech clinical study sponsors and clinical research organizations (CROs).
Additional Audience: Clinical research sites, research coordinators, clinical research institutions.
Approximately 120 minutes ( 2 hours).
Victor is an industry expert on budget development and negotiation for Investigative Sites, and is part of the Business Analytics team for heritage Celgene. After originally working in the labs, he has worked in the pharmaceutical industry for over 15 years. While at Celgene, in 2010 he was responsible for developing and implementing new procedures for site budget development to reflect business and study needs at that time. Victor then created a new site budget appendix format with a separate payment terms document, which have been in use since Jan 2012. As process owner, he has evolved these templates over time to improve negotiation efficiency and to incorporate current industry trends. Victor continues to lead and participate in many initiatives for process improvement within CR&D, coordinating with clinical functions as well as finance and project management. In his role within Business Analytics, his main responsibilities are budget forecasting for clinical trials and development of investigator grants; from providing high-level estimates for a study concept, preparing detailed estimates for governance presentations, and to the creation and approval of global site budget templates based upon a finalized protocol. As part of this function, he also helps clinical teams with protocols and amendments in development to mitigate complexity with trial design. Victor has experience with investigator- and sponsor-initiated budgets for clinical pharmacology through post-marketing studies, primarily in oncology but other therapeutic areas as well. Victor graduated Rutgers University in the pre-medical track with a B.S. focusing on human biology.
Course takers are encouraged to submit course description, course length and course agenda directly to their specific certification associations to confirm course completion will be accepted as part of their continuing education requirements.
Agenda AND Certificate of attendance and/or letter signed by supervisor. Course Agenda and Certificate of Attendance (at course completion) will be provided to our course takers.
Please contact ACRP directly with this course title, timed agenda/course overview, and objectives included on this page for their approval as a continuing education course in your re-certification.