How to Develop a Global Clinical Trial Budget Like a Pro
The Role of Trial Design and Protocol Complexity in the Overall Budget for Clinical Studies.
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Course DescriptionWith drug development costs at an all-time high and a big focus on cost reduction, it is important for clinical trial professionals who are responsible for developing and managing clinical trial budgets to be well-equipped with the necessary knowledge to prepare, defend and manage clinical trial budgets that are accurate and robust.
In this course you will learn the following:
- The different sub-categories within the overall study budget and the main cost drivers of each
- How each cost driver impacts your overall study budget
- What questions to ask during the different stages of clinical study planning
- The operational, scientific and strategic considerations that impact your study budget
- Special budget considerations for outsourced studies
- The hidden costs driven by protocol design and complexity
- Investigator Grants – Main cost drivers, questions to ask and best practices for what to include within this major sub-category of your study budget
- And finally… how to develop a global clinical trial budget like a pro!
Main Audience: Clinical trial professionals responsible for developing, managing or overseeing clinical trial budgets at pharmaceutical and biotech organizations (study sponsors).
Additional Audience: Other clinical trial / clinical research professionals interested in learning more about the topic of clinical trial budgets both at pharmaceutical and biotech companies as well as clinical research sites.
Approximately 120 minutes ( 2 hours) plus course bonus content
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.