Contracts & Regulations

• Through Partners Healthcare System, the Translational Medicine Group has extensive and established contracting experience with
• Data coordinating centers
• Clinical investigation sites
• Vendors
• Biopharmaceutical industry sponsors
• IRB review
• Executed agreements with multiple independent IRBs for review of industry sponsored multisite Phase III and IV clinical trials
• Partners IRB reviews data coordinating center function but clinical protocol can be reviewed by single external IRB
• Existing multiple protocol reliance agreements
• Prioritized review for TRC clinical protocols