Negotiating Clinical Trial Agreements and Budgets for Study Sponsors
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A Comprehensive Presentation on Clinical Trial Site Agreements and Budgets From a Study Sponsor Perspective
This virtual workshop presentation was conducted as part of the Virtual ClinBiz Summit 2020 in September 2020. The following topics were covered in this comprehensive workshop presentation:
- Overview of clinical trial agreements, areas of negotiations and site budget development for study sponsors
- Standard of Care (SOC) and Fair Market Value (FMV) in investigator site budgets
- Common challenges associated with clinical trial agreement negotiations, and ways to significantly improve these
- Different industry templates, initiatives, tools and contract language used by study sponsors, study sites and CROs along with the strengths and weaknesses of each
- Open Forum questions from attendees and responses from presenters on specific challenges they’ve encountered and possible solutions
Your Instructor
Débora S. Araujo has over a decade of experience in the pharmaceutical industry working and consulting for Fortune 500 companies. During her time in this industry her special focus has been on the business aspects of clinical trials including: clinical contracting and financial management, clinical outsourcing and CRO/vendor management, global clinical trial budgeting and forecasting, clinical financial analytics and metrics/KPIs, site budget development and negotiations, Fair Market Value (FMV) and global investigator site payments. She has also utilized her expertise and knowledge to drive practical change in this industry via thought leadership material, conference presentations and consulting engagements.
Débora’s passion for driving practical change in the industry led her to launch ClinBiz (www.clinbiz.com), an online platform with a dedicated YouTube channel, podcast, blog and much more where clinical research professionals can stay connected and updated on the latest topics, trends and technologies related to the business aspects of clinical trials. Débora has also recently published a book on clinical trial agreement negotiations named ‘The Four Villains of Clinical Trial Agreement Delays and How To Defeat Them’ which quickly became an Amazon’s #1 New Release in the pharmaceutical and biotechnology category.
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