Sponsor Information

• Standard Operating Procedures for clinical trials management
• QA audit tools and procedures for FDA compliance
• Competency documentation tools for clinical trials staff
• Training in the clinical trials industry (GCP & ICH) and FDA regulations for clinical trials staff
• IATA Certified staff
• Human Participant Protections Education for all Staff
• Human Subject Assurance Training for all staff
• Ongoing review of clinical trials regulations and system adaptation
• Prompt turn-around of regulatory documents, contracts, and budgets
• One person contact for all study-related issues
• Subject recruitment plan and execution
• Computerized software for daily tracking of patient activity
• Accurate results in a timely manner with data integrity
• Well trained coordinator staff currently 2 Certified Coordinators and one Certified PI
• Large database to recruit subjects and patients
• Use of a central IRB which facilitates timely approval of amendments
• Great clinic locations (easy access to Highways, Turnpike, Train, & Airports)
• Demographically, ethnically diverse patient population
• High enrollment of past studies
• Extended hours 6 AM - 7 PM, Monday to Friday
• Open Saturday as needed
• Adult pharmacokinetics capability (-70¡ freezer)

Also, in addition to having professionally trained staff and adhering to FDA, GCP and ICH guidelines, patient safety remains our focus while exceeding study enrollment and completion timelines.

Diagnostics/Clinic Equipment
CLIA; Freezer (-20 deg. Celsius) & (-70 deg Celsius); Centrifuges; Emergency Cart (with BLS certified staff); Dry Ice; Drug Storage - limited access, temperature monitored; Diagnostic Bladder Ultrasound; Refrigerated Drug Storage; Transrectal Ultrasound; 12 lead EKG; Cystoscopy; Pelvic Ultrasound; Doppler Ultrasound; Rigiscan; Biofeedback; Urodyn 1000 Uroflow; Brachytherapy.

We have access to many other diagnostics such as:
Ultrasound; MRI; CT Scan; Mammography; Diagnostic X-Ray; Bone Mineral Density- DEXA scan.