Phase I Capabilities
Our fully-equipped Phase I unit is an ideal solution for conducting both healthy volunteer and patient population trials. Our Phase I unit 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 Phase I experience across numerous therapeutic areas and experience in both First-in-Human and BA/BE studies.
Clinical Team Experience
With many of our PIs delivering over a decade of experience, CPI certification, and proven success in Phase I trials, our PIs are among the most qualified in the industry. All of our PIs are supported by an established and highly experienced Phase I team. This ACLS trained team includes nurses and paramedics with many years of experience who are fully capable of performing multiple types of Phase I clinical trials.
Expanded Phase I Clinical Research Facilities
Avail Clinical Research’s state-of-the-art facility has expanded to a 50 bed unit. The facility features cutting edge instrumentation to enable and support safe, reliable and efficient early phase studies in a controlled environment. Avail can comfortably accommodate 50 in-patients at a time using five living units that can segregate patients according to protocol requirements. The facility is supported with two in-house laboratories, both of which are CLIA and CAP certified.
Our upgraded Phase I unit features:
- Five living units with 50 Beds
- Inpatient and Outpatient Facilities
- Adjacent to major area hospital
- Full schedule DEA licensing
- CLIA and CAP certified on-site laboratory
- Laminar Flow Hood
- Diagnostic imaging (MRI, PET, Ultrasound, CT)
- X-Ray Unit
- Wireless Telemetry
- Polysomnography equipment/unit
- Pulmonary unit with spirometers and peak flow monitoring
Ability to Expand into Adjacent Hospitals: We’ve worked to maintain extensive and integrated relationships with adjacent hospitals. In fact, our built-to-suit facility is within walking distance from Florida Hospital DeLand. This grants us the ability to efficiently increase bed capacity for larger cohorts and high volume studies.
- Infectious Disease
- Healthy Adult
- Healthy Elderly
- Single Ascending Dose
- Multiple Ascending Dose
- Proof of Concept (POC)
- Adaptive Design
- Healthy Volunteer
- Healthy Elderly
- Human Abuse Liability & Substance Abuse
- Transdermal Patch
- Cardiac Safety/Intensive
- Pulmonary Function Testing
- First to File
- Drug-Drug Interaction
- Food Effect
- Age and Gender Effect
- Patient Population Trials
Phase I Unit Amenities and Capabilities
Overnight Dorm-Style Accommodations: Our facility has been expanded to include 50 beds in dormitory-style patient accommodations with telemetry monitoring and safety surveillance. The centralized clocking and alerting system is synchronized with the laboratory and patient rooms. We have implemented an even more intelligent design to ensure patient privacy and comfort.
Fully Equipped Kitchen: The Phase I unit has its own fully equipped kitchen so our participants never need to worry about food. We’ve even hired cooks and dieticians for onsite meal planning, food preparation and supervision to ensure complete compliance with the study protocol.
Fully Stocked Rec Room: There’s no need to wonder how our participants will spend their downtime, because our facility has two dedicated entertainment and recreation rooms featuring big screen HDTVs, billiards, foosball, board games, Wii and Wi-Fi internet access. We provide four internet stations for patients who don’t have computers. There’s also an expansive outdoor patio for patient recreation in a controlled setting.
On-Site Lab: Our new onsite early phase laboratory is Biosafety Level III qualified and features sealed negative pressure capabilities, externally vented Laminar Flow Hood, HEPA controlled and isolated HVAC system and double door controlled entry for personnel. The lab has been specifically designed to support advanced onsite drug preparation and administration.
Our Phase I facility is also supported by three dedicated procedure/IV infusion rooms, seven dedicated examination rooms and an in-house X-Ray suite.
Learn More About Our Facility and Capabilities
- Areas of Expertise
- Areas Served
- Contract Research Organizations
- Institutional Review Boards
- Our Medical Staff
- Clinical Trials with Local Doctors
- Pharmaceutical Sponsors
- Phase II-IV Capabilities
- Patient Demographics
- Patient Recruiting Expertise
- Patient Retention Strategy
- Rapid Start-Up
- Vaccine Capabilities
- World-Class Data Collection
- Lodging & Transportation Resources