For Sponsors
BTC of New Bedford has many of the features Sponsors and CROs seek when selecting a research site. Some of our facility highlights include our Quality Assurance Program, Rapid Study Start Up, and Rapid Enrollment Ability.
Quality Assurance Program
Precise project and staff management- GCP Training, HIPAA compliance training, OSHA compliance, internal audits, established and effective SOPs (Volunteer Informed Consent, drug accountability, Adverse Event reporting, drug storage, Serious Adverse Event (SAE) reporting, and site responsibility log for all involved in each trial.)
Rapid Study Start-Up & Rapid Enrollment Ability
BTC of New Bedford can complete budget negotiations in less than two weeks’ time. Rapid enrollment is possible because of the site’s large participant database. Staff can also quickly develop effective recruitment campaigns focused on individual study needs.
Site Equipment
- Access to Beds
- -20° Freezer | -70° Freezer
- Electrocardiogram Machines
- Digital Vital Signs Monitors
- Fully Equipped Laboratory
- Refrigerators for Specimens
- Refrigerated Centrifuges
- Pharmacy/Drug Storage Room
- Conference Room
- Kitchen/Dining Rooms
- Monitoring Rooms
- Patient Examination Rooms
- Recreation/TV Rooms
- Admission Area
- Outpatient/Screening Area
- 12 Lead EKG
- Biofeedback
- CLIA
- Dry Ice
Diagnostics Availability
BTC of New Bedford has access to many other diagnostics such as:
Bone Mineral Density - DEXA scan
CT Scan
Diagnostic X-Ray
Mammography
MRI
Ultrasound
Additional Features and Highlights
- 24-hour emergency phone number
- 24-hour fax line
- Full CTMS integration with searchable participant database
- QA audit tools and procedures for FDA compliance
- Competency documentation tools for clinical trials staff
- IATA certified staff
- Human Participant Protections Education for all staff
- Ongoing review of clinical trial regulations and system adaptation
- Prompt turn-around of regulatory documents, contracts, and budgets
- One primary contact for all study-related issues
- Subject recruitment plan and execution
- Accurate results in a timely manner with data integrity
- Well trained staff – currently 5 Coordinators and 3 Principal Investigators
- High speed internet access with wireless capabilities
- High enrollment of past studies
- Open Saturday as needed
- Culturally diverse participant population with an extensive participant database
- Experience working with many central IRBs, such as Quorum, Schulman, Copernicus, and others