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

Site Qualifying Criteria
All fully integrated BTC Network sites have to pass rigorous screening requirements in order to be added to our group. Some of those requirements include:

Superb communication

Diverse therapeutic experience and large clinic patient population

Complete research staff infrastructure (PIs, Sub-Is, Coordinators)

Compliance with all BTC Network SOPs and quality assurance system in place

Ability to meet and maintain network processes and standards
Patient Recruitment

ADVERTISING MATERIALS
Local and study specific advertising including TV, radio, newspaper, print, and online

LOCAL & NATIONAL ENGAGEMENT
Remote outreach to key support groups & foundations

LOCAL & COMMUNITY ENGAGEMENT & INTERACTION
Community liaison works with physicians/clinics and local businesses and sets up health fairs and patient groups

ACCESS TO EMR PATIENT COMMUNITY
HIPAA Business Agreements allow Direct Access by BTC

BTC PATIENT COMMUNITY
Patients consistently engaged through newsletters and can search trials of interest by geographic location and therapeutic area