Sponsors & CROs
South Florida’s leading site for high-performance trial execution and sponsor collaboration.”
Our Process
Sponsors & CROs Partners
Clinical Development
Fast Startup • Clean Data • GCP-Proven Accelerated timelines powered by operational agility and precision. We deliver Phase I–IV trials with speed, protocol fidelity, and sponsor-aligned execution.
Regulatory & Access
IRB Ready • Part 11 Compliant • No Delays We fast-track regulatory workflows with clean IRB submissions, centralized document control, and real-time updates—led by a GCP-certified regulatory team.
Biotech
Flexible • Science-Driven • Early-Phase Ready From first-in-human to expansion, we support biotech innovation with adaptable operations, therapeutic expertise, and fully engaged study teams.
Functional Service
Scalable • Embedded • Quality Assured Our CRCs, raters, and QA professionals integrate seamlessly into your program—delivering high performance, GCP-trained support without added overhead.
Equipment
Facility & Equipment Matrix
Area / Equipment
Physical Site
Specs / Certification
19 000 sq ft, two-story building
Credential / Avg. Experience
Dedicated phase I ward, imaging wing & subject café, 26 subject parking.
Subject Café (1st floor)
Continental breakfast & lunch, Wi-Fi, games
Keeps volunteers comfortable during long visits—improves retention
Long-Term Archiving Suite
3 000 sq ft, 25-yr record storage (Part 11 / HIPAA)
Exceeds ICH-GCP retention requirements
–80 °C Freezers
4 units, temp-probe with SMS alerts & generator backup
Secure PK / biomarker storage
Pharmacy Refrigerators
18 units, NIST-traceable probes
Segregated IMP, backup power, excursion logs
Cold Centrifuges
6 units, 4 °C fixed-angle & swing-bucket
Immediate plasma separation on site
Redundant Power — Diesel back-up generator
(tested weekly) keeps the entire facility—minus 80 °C freezers, pharmacy refrigerators, and network—fully powered for up to 72 hours, ensuring uninterrupted operations during hurricanes or any regional outage.
On-Site Lab
CLIA-certified; CBC, CMP, coag, rapid troponin
Same-day safety results; no courier delays
Crash Cart & AED
Monthly checks; ACLS-trained staff
Immediate emergency response capability
FibroScan® 530 Compact
CAP & stiffness
Ready for NASH / MASH endpoints
3 T MRI (PDFF & MRE)
Siemens VIDA
Fat fraction & stiffness endpoints
PET-CT
Amyloid & tau imaging
Neurology & Alzheimer’s protocols
Spirometry Suite
ATS-certified devices
Asthma / COPD trials
Phase I Inpatient Unit
8 beds, negative-pressure room
FIH & SAD/MAD dosing safety
E-Reg / CTMS
RealTime CTMS – 21 CFR Part 11 compliant
Remote monitoring, eSource, eConsent
Our Staffing
Staffing & Credentials
Role
Principal Investigator
Head-Count
2
Credential / Avg. Experience
11 yrs; 98 trials; 2× FDA NAI
Sub-Investigators
3
IM, Neuro, Nephro/Critical Care
Nurse Practitioner (ER)
1
10 yrs trauma-center background
Regulatory Team
4
RN lead (5 yrs, prior FDA audits) + 3 specialists—rapid IRB/Budget turnaround
Registered Nurses
4
IV-certified; ACLS/BLS
Clinical Research Coordinators
9
ACRP/SOCRA, mean 5 yrs
Certified Raters
4
3–7 yrs; audio + video-recorded scale administration
Quality & Compliance Auditor
3FTE
Reviews each visit ≤48 h
Registered Dietitian
1
Lifestyle counseling & nutrition logs
Recruitment Team
2
Bilingual EN/ES; 200 prescreens / mo
24/7 On-Call MDs
Rotating
Immediate AE response
Metrics
Population Diversity & Volunteer Care
Metric
Demographics
Detail
66 % Hispanic, 33 % African-American registry
Outreach
Bilingual campaigns; partnerships with churches & clinics
Transportation
Free round-trip car service for participant + partner; free parking pass if self-driving
On-Site Companionship
Volunteers may spend the day in our café lounge with board games, streaming, and reading books
Stipends
Printed check automatically generated before participant leaves each visit
Retention & Safety Highlights
Retention & Safety Highlights
- Two FDA inspections (2019, 2024) — No Action Indicated
- 67 sponsor audits with no action indicated
- Phase I ward + ER-trained NP and critical Care MD ensure rapid intervention if needed
- 25-year compliant document archive safeguards study data integrity
