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FOUR STUDY PHASES

RESEARCH PROGRESSES

There are four phases, and each phase is considered a separate study. At the end of each phase, investigators must submit their data to the FDA for approval before continuing to the next phase. After phase three, companies can request FDA approval to market their medicine.

RESEARCHING WORLD-CHANGING MEDICINE

Every day we make a difference. Every day we approach clinical research with efficiency and care. Every day we find new and better ways to prevent, detect, diagnose, control, and treat illnesses.

QUALITY RESULTS :

We deliver quality results for trial services, imaging services, trial design, and much more. Discover all the services we provide.

ADVANCED FACILITIES :

Our modern facilities and clinics feature cutting-edge equipment and an industry-leading team. See what our facilities can offer your study.

EXPERIENCED STAFF

We’re passionate about our work, and it shows. We get more of the right patients through the door and conduct all of our research with integrity. Learn more about our team and culture.

EXPERIENCE EXCELLENT SERVICE

We offer professional trial, recruitment, and administrative services across all trial designs. We approach our work with integrity and collaboration, which leads to excellent service and quality results.

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
  • PK Sampling
  • Polysomnography (PSG) / Electroencephalography (EEG)
  • Spinal Cord Stimulators
  • Spinal Nerve Blocks
  • Surgical Center for Pain Management

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