Clinical Pharmacology Unit with Extensive First-in-Human, BA/BE Experience

Our fully-equipped Clinical Pharmacology Unit is an ideal solution for conducting any early phase study for healthy & special volunteer population or early patient trials.  Our facility provides a comfortable and safe environment for study participants who are monitored and supervised by our certified investigators and experienced study team. We offer successful early phase experience across numerous therapeutic areas several trial types such as First-in-Human (FIH), PK/PD, Food Effect and BA/BE studies.

Clinical Team Experience

With many of our PIs delivering over a decade of experience, CPI certification, and proven success in early phase trials, our investigators are among the most qualified in the industry.  All of our PIs are supported by established and highly experienced clinical teams.  These ACLS trained teams include nurses and paramedics with many years of experience performing multiple types of early phase clinical trials.

Clinical Pharmacology Unit

Our recently renovated and expanded 50-bed early phase unit has an impressive array of capabilities. Not only can we comfortably accommodate 50 in-patients at one time, but the layout allows us to segregate patients according to cohorts, gender or in a controlled quarantine environment.

The early phase laboratory has a CLIA waiver, CAP certified, and built to BSL-II standards. It houses a BSC Class II laminar flow hood for easy preparation of study drugs by our pharmacist with dedicated dosing areas.

The overall facility encompasses over 18,500 square feet and is located adjacent to Florida Hospital DeLand which has been supporting our conduct of clinical trials for nearly two decades.

Capability to Expand into Adjacent Hospitals: Accel’s extensive and integrated relationships with adjacent hospitals allow us the ability to increase bed capacity for larger cohorts and high volume studies.

Clinical Study Capabilities

  • testing
  • First-in-Human (FIH)
  • First-to-File
  • Dose Escalation
  • Single/Multiple Dose
  • Proof of Concept
  • Human Abuse Liability
  • Biosimilar
  • Vaccine Challenge
  • Bioavailability / Bioequivalence
  • Pharmacokinetic (PK)
  • Pharmacodynamic (PD)
  • Food Effect
  • Drug-Drug Interaction (DDI)
  • Age and Gender Effect
  • Thorough QT

Normal Healthy and Special Volunteer Populations

  • Normal Healthy Volunteers
  • Cardiovascular Disease
  • Diabetes
  • Hyperlipidemia
  • Hypertension
  • Asthmatic
  • Chronic Pain (Migraine)
  • Obesity
  • Postmenopausal Women
  • Elderly (65 years and older)
  • Renal Impairment
  • Hepatic Impairment
  • Parkinson’s Disease
  • Arthritis (Osteoarthritis and Rheumatoid)

Multi-Therapeutic Expertise

  • Cardiovascular
  • Pulmonology (COPD)
  • Infectious Disease
  • Orthopedics
  • Sleep Disorders
  • Ophthalmology
  • Internal Medicine
  • Gastroenterology
  • Neurology (CNS)
  • Dermatology
  • Immunology / Vaccine
  • Men’s/Women’s Health
  • Endocrinology
  • Internal Medicine

Dosage and Delivery Forms

  • Oral
  • IV Infusion
  • Injectable
  • Topical
  • Transdermal Patches
  • Inhalation
  • Intranasal
  • Sublingual

Amenities for Study Participants

  • Single Beds
  • Wireless Internet Access
  • Multiple Entertainment Options
  • Outdoor Patio
  • On-site Kitchen
  • Full-service Catering

Clinical Pharmacology Unit Access

Restricted access with security monitoring to ensure subject safety and protocol compliance.