Negotiating Clinical Trial Agreements For Study Sponsors
Recorded Online Workshop Session
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 the contract language. The respective speaker slides are also included. The recorded workshop session covers the following:
- Overview of clinical trial agreements and areas of negotiations for study sponsors
- Discuss common challenges associated with clinical trial agreement negotiations, and ways to significantly improve these
- Explore different industry templates, initiatives, tools and contract language used by study sponsors, study sites and CROs along with the strengths and weaknesses of each
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: Those from Clinical Trial and Research Industry.
Approximately 90 minutes ( 1 hours 30 minutes).
Virginia (Ginny) Gilbert is an Associate Director of Global Site Agreements in the Global Clinical Trial Operations group at Merck Sharp & Dohme. Currently the lead for Latin America site agreements and Vendor Qualifications, she has over 16 years of experience in the pharmaceutical and legal industry managing and negotiating clinical trial agreements and site budgets in all phases of research, as well as consulting agreements, investigator-initiated study agreements, and confidentiality agreements.
Prior to joining Merck, Ginny worked for Schering-Plough, clinical research organizations and in private legal practice. She earned her Juris Doctor from Wake Forest University School of Law and Bachelors of Arts in English and Political Science from Washington & Jefferson College.
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.
Requirements for SOCRA's Re-Certification Continuing Education for Web Based/Online Coursework:
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.
Requirements for ACRP Re-certification Continuing Education
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.