The QPS Miami site is a multi-specialty research center with 90 employees, including 2 board-certified physicians, in a 20,000 square foot clinical space.
- Phase I – II a/b clinical trials.
- Phase I – III vaccine trials.
- Study types include: SAD/MAD, BE/BA, PK/PD, food effects, QTC, proof of concept, drug interactions, biologics, and vaccines.
- Special patient populations include: elderly, post- menopausal women and hypogonadal males.
- Study indications include: NASH, fatty liver, diabetes, OA/RA, Parkinson’s disease, migraines, gout, male hypogonadism, obesity, hyperlipidemia, hypertension, women’s health, and more.
- Vaccine research study experience includes: Covid-19, Ebola, Human Immunodeficiency Virus (HIV), Human Papillomavirus (HPV), Influenza, Pneumococcus, Rabies, Respiratory Syncytial Virus (RSV), Zika, and more.
- Full-service on-site sample processing laboratory
- USP 797-compliant pharmacy with compounding capability.
- Peripheral blood mononuclear cell (PBMC) laboratory.
- 95-bed Phase I unit.
- Access to Wireless Telemetry, Ultrasound, Dual Energy X-Ray Absorptiometry (DEXA), Polysomnography (PSG), Magnetic Resonance Angiography (MRA), Computed Tomography (CT), X-Ray, and Holter monitoring.
- Refrigerated centrifuges.
- Electronic lab transfers.
- RSVP system – a fingerprinting system to prevent patients from entering multiple trials at the same time.
- In-house call center with specialized patient recruitment services.
- 2 Principle Investigators (PIs): board-certified Rheumatology and Internal Medicine, with access to a wide variety of specialty physicians.
- 2 nurse practitioners.
- 2 pharmacists.
- 10 nurses.
- 9 lab technicians, including PBMC support
- 60 support staff including: study coordinators (with on average 8 years of clinical research experience), Quality Assurance personnel (with on average of 18 years clinical research experience), Quality Control personnel, regulatory personnel, 7 call center specialists and 12 screening and pre-screening coordinators.
- Last 14 routine FDA audits, no 483s issued.
- A robust database of 35,000 subjects/patients.
- Association for the Accreditation of Human Research Protection Program (AAHRPP) accredited.
- All licensed staff (physicians, nurses, and paramedics) are trained in Advanced Cardiac Life Support (ACLS).
- All staff are trained on basic life support (BLS).
- Over 2,000 clinical trials conducted across Phase I, Phase II a/b, Late Phase and Vaccines.