Profile
Contact Information
Center Information
Madelaine PerezDirector of Clinical affairs and operations
400 15th street North
St. Petersburg, FL 33705
Email: mperez@researchgcp.com
Phone: 727-520-1427
Fax: 727-520-9427
www.researchgcp.com
Center Overview
Research GCP is a state-of-the-art research facility designed to conduct your trial in the most efficient, high-quality and with a priority on safety execution, Established in 2009.
Research Experience
Our executive team has over 175 years of combined experience in Phase I – IV Clinical Research, Personal Health Care/ Consumer Products, Irritation and sensitization trials, and Medical Devices.
2 Clinical Pharmacology Research Units in Florida. Total of 44 beds – St. Petersburg, FL (Tampa Bay) and Ocala, FL (Gainesville/Northeast FL)
Focus on Phase I – IIa trials
Considerable experience in all Phases of Clinical Research.
Vast experience with Biologics and Vaccines
Facility Description
44 Beds:
24-Bed CRU: St. Petersburg, FL and 20-Bed CRU: Ocala, FL
On-Site Pharmacy (Compliant to FDA, DEA II – V license)
Heart Station: EKG Machine, Echo-ECG, Holter Monitoring, Ambulatory Blood Pressure Monitoring, Infusion Stations
Laboratory with phlebotomy and On-Site processing
Psychometric Testing, VAS Scales
Pulse Oximeters, Calibrated Spirometer, Pharmacy flow hood
Digital X-ray, endoscopy, ultrasound network, Fibroscan, incubator, lumbar puncture
Partnership with imaging facilities: MRI, CT / PET Scan
Within 1 mile of a local hospital and within 0.5 mile of Fire Rescue.
Investigator Experienc
Dr. Lawrence Galitz M.D., 22+ years of Phase I Clinical Research experience. Over 600 Phase I trials and over 50 Phase II-IV trials.
Dr. Gualberto Perez, M.D., LCLT, CCRC, CPI, Principal Investigator, 30+ years experience.
Dr. Wanda Boote, M.D., 30+ years of experience, Board Certified Dermatologist, Principal Investigator.
Dr. Enrique Villareal M.D., 10+ years of experience, Board Certified Psychiatrist, Principal Investigator.
Staff Expertise
Madelaine Perez, PhD, MS, LCLT, Director of Clinical Operations, 28+ years of experience.
Jessica Cruz, BSN, Manager: Phase I- IV, 8+ years of experience.
Marlon Antonio Perez, Chief Operation officer, 8+ years of experience.
Patient Demographics
Database with 8,551 active subjects for both sites, Panels reflect our subject diversity: race, ethnicity, age and gender.
Research GCP-Global Clinical Professionals is advantageously located for the convenience of our patients/subjects, clients/sponsors as well as our own staff
Subject Retention: 99%
Normal Healthy Volunteers
Elderly
Postmenopausal Females
Pediatric (0 to 36 months babies, Children)
Hepatic Impaired
Renal Impaired
Peritoneal Dialysis
Hemodialysis
Autoimmune Diseases
Post-Menopausal
Hypogonadal
Atopic Dermatitis
Eczema
Psoriasis
Actinic Keratosis
Acne
Rosacea
Skin Allergies
Scalp Dandruff
Alopecia
Hyperpigmentation
Scars | Hypertrophic Scars
Other Information
Full Trial Management Capabilities: A Partner to compliment your in-house competencies
Data Management
PK/Biostats
Medical Writing/Protocol Writing
Project Management
Regulatory
Additional Instructions
Extensive Clinical Research experience in Phase I – IV, PHC/OTC
Experienced Senior Management TEAM engagement throughout
Dedicated TEAM of experienced Clinical Research professionals – Committed to Subject Safety
Agile and Highly Responsive Team from initiation to study close-out – attention to detail
Vast recruiting capabilities. Exceptional retention.
Proven FDA preparedness with no site 483’s noted