Network Services

Start Up

• Configure mutual confidentiality among all network sites
• Projection of total enrollment through centralized feasibility
• Setup of centralized contract and budget for all sites
• Coordination of all study start-up meetings with sites (investigator meeting, trainings, etc)
• Collaboration with CRO to ensure study documents are completed in a timely manner

Implementation

The BTC Clinical Trial Manager will be the liaison between the sponsor/CRO team and the sites

• Review of site performance & protocol compliance
• Discussion of enrollment numbers and proactive resource management with the sites
• Centralized grant payments, reconciliation, and pass-through invoicing
• Ongoing QA review, including SAE reporting and periodic on-site visits

Close Out

• QA and processing of IRB close-out reports
• Coordination of expedited EDC signing
• Return or destruction of study product
• Study archiving coordination
• Processing of any holdback percentage