Sponsor/CRO Info
Our Team
- All Board-certified physician investigators and sub-investigators with GCP & HSP training
- ACLS & BLS Certification
- Certified Clinical Research Coordinators with GCP, HSP & IATA Training
- Quality Assurance Department for training coordinators and investigators
Our Facility
- Within two miles of a hospital/emergency department
- On-site phase II – IV clinical trials – 4 examination rooms
- Off-site phase I clinical trials
- Back-up generator
- Dedicated monitoring room
- Dedicated Coordinators area
- High-speed Internet Connectivity
- Access-controlled clinical and regulatory office/area
- Annual Calibration records
- 12 Lead ECG, Echo-ECG and Holter Monitoring
- Centrifuges
- Incubator
- Scales
- Crash Cart
- Blood pressure equipment, pulse oximeter, Ophthalmoscope, Otoscope
Laboratory
- CLIA Certified Laboratory with Phlebotomy and on-site processing
- Extended stay Pharmacokinetic test facilities
- -20 oC Freezer
- -80 oC Freezer
- 2 – 8 oC Laboratory Refrigerator
- Centrifuges
- 24/7 Temperature monitoring with alarm for Laboratory freezers & refrigerators.
- PK/PD sampling, processing & storage
- On-site peripheral blood mononuclear cell (PBMC) and Flow Cytometry collection. Our Lab ensures that blood samples are routinely processed and delivered within less than 6 hours of collection yielding excellent viability
Pharmacy
- Locked, restricted access and temperature controlled Investigational Drug Storage facilities
- Locked, Ambient Temperature Cabinet for Investigational Drug
- Locked 2 – 8 oC Investigational Drug Refrigerator
- 24/7 Temperature monitoring with alarm for Investigational product storage
- Unblinded Pharmacist and Back-Up when required per protocol
- Extensive experience in the dispensation, preparation and administration of IV, IM, SQ, Oral, Topical, Transdermal and Sublingual formulations
We utilize CRIO
Our Capabilities
- Biopsies (skin, liver, endometrial, adipose)
- Radiology (DXA scan, MRI, MRE, Ultrasounds, X-rays, Mammogram, Endoscopy, Colonoscopy, CT scan)
- Cardiac/Holter monitoring
- Infusions/PICC lines
- Feasibility within 24 hours
- Regulatory Start-Up and IRB Submission within 3 – 5 days
- Budget & Contract review within 48 – 72 hours
- Budget worked in parallel with Regulatory Start-Up
- Over 20,000 patients within Database to improve enrollment
- Virtual/remote/telehealth capabilities
- CRIO eSource
- CRIO eRegulatory for 24/7 access to monitoring data
Sponsors We have Worked With
