See What We Can Do
Phase 1 Highlights
- Certified C2N Center (48-hour CSF, radiolabeled leucine)
- First-In-Human Center for major pharmaceuticals/CROs
- Experienced in administering First-In-Human Biologicals
- Advanced Cerebrospinal Fluid Collections
- Adverse Event Evaluation
Orlando Phase I Features
- 54-bed inpatient unit – including individual rooms for special populations
- First-In-Human capabilities
- 6 Full-time Medical Doctors
- 16 Nurse/Paramedic Patient Care Technicians
- 8-bed intensive treatment room equipped with crash carts, telemetry, emergency telephones, automated external defibrillators (AEDs), and oxygen tanks
- 24-hour Advanced Cardiovascular Life Support (ACLS) certified medical staff
- Centralized clocking and alerting system synchronized with laboratory, pharmacy and patient bedrooms
- Central nurse’s station with viewing of treatment room and camera monitors covering patient hallways
- Dormitory-style patient rooms
- Large recreation room with 55″ TV, Wii, board games, and laptops with Wi-Fi access
- Expansive outdoor patio within view of nurse’s station
The Villages Phase I Features
- 34-bed inpatient unit
- 12,000 square feet
- Psychiatrist and 6 psychometric raters
- 10 Full-time Clinical Research Coordinators
- Full-time Data Manager
- 20 Nurse/Paramedic Patient Care Technicians
- 24-hour Advanced Cardiovascular Life Support (ACLS) certified medical staff
Special Procedures
Experience and experts in:
- Biopsies (Skin & Muscle)
- Bronchoscopies
- Cardiac Telemetry
- Conscious Sedation
- Continuous and Serial CSF Sampling
- Device Breath Testing
- Food Effects
- Gastric Emptying studies
- Home Health
- Implantable Medical Device Studies (Diabetics)
- Mass Balance
- PFTs
- Plasma Pheresis
- PBMC Cell Washing
- PK Sampling
- Polysomnography (PSG) / Electroencephalography (EEG)
- Spinal Cord Stimulators
- Spinal Nerve Blocks
- Surgical Center for Pain Management
Imaging Capabilities
- Magnetic Resonance Imaging (MRI)/ Functional Magnetic Resonance Imaging (fMRI)
- Diffusion Tensor Imaging (DTI)/Arterial Spin Labeling (ASL)
- Positron Emission Tomography (PET)
- Single-Photon Emission Computerized Tomography (SPECT)
- Computerized Tomography (CT)
- Dual X-ray Absorptiometry (DXA)
- Radiotracer Imaging
- Flurodeoxyglucose (FDG)
- Amyvid, Flutemetamol
- Carbon-13
- Technetium-99
- Chromium-51
- Iodine-131
- Investigational radiotracers
Special Population Experience
- Healthy Elderly
- Hepatic Impaired
- Lupus
- Macular Degeneration
- Migraine
- Mild Cognitive Impairment
- Multiple Sclerosis
- Osteoarthritis
Source Documentation & Data Management
- 2 Full-time source document personnel
- 7 Full-time dedicated data management personnel
- Professional development of initial templates at study start
- Manages all revisions as amendments are received
- Creates and ensures study specific documents are based upon study protocol and CRFs
Training & Quality Management
- 2 Full-time source document personnel
- 7 Full-time dedicated data management personnel
- Professional development of initial templates at study start
- Manages all revisions as amendments are received
- Creates and ensures study specific documents are based upon study protocol and CRFs
Subject Recruitment & Project Management
- 18 Full-time Subject Recruitment Specialists
- Research database with more than 100,000 subjects
- Referral network of more than 35 participating physicians and practices
- Aggressive and targeted local advertising
- Television, Radio, Newspaper, Digital Advertising, Social Media,
- Email Blasts, Press Releases, Physician Referrals
- Community Outreach and educational seminars
- Clinical research overview
- General medically-based community events
- Large Prescreening Team adept at mitigating screen failure outcomes
- Site IRB-Approved non-study specific Prescreening Consent for Pre-SIV subject prescreening
