Webvent

SCRS Sites Directory

Search SCRS member sites. Discover current trials.

Florida Institute For Clinical Research, LLC

Helping others while helping yourself

Florida Institute For Clinical Research, LLC

Welcome to the Florida Institute for Clinical Research, LLC (FICResearch.com)
10967 Lake Underhill Rd.
Suite 117
Orlando, FL 32825
(407) 658-0966
SITE BACKGROUND AND EXPERIENCE:
In January 2009, we started conducting phase II-IV PK and non-PK, Pulmonary - Asthma, COPD, Diabetes, ADHD and Children studies. During the past four years we have participated in over 100 different clinical trials, enrolling over 250 patients into different studies. At any time our staff is involved in 5-10 clinical trials, many of them involving 20-40 patients. We have a large database that we pull patients from. Currently, the site has several studies ranging from Phase II-V, accepting Phase I, and including roll-over and expanded access clinical trials. Our site has been audited by CROs due to the high enrollment with all good out come and told we do great data capture.
We specialize in, but are not limited to, clinical trials for adults and children. We have also participated in a vaccine trial in healthy volunteers. In addition, we are part of the NIH funded network program and ACRP.

FICResearch is located at 10967 Lake Underhill Rd Suite 117 Orlando, Fl. 32825 just 10 minutes from Orlando International Airport.

STAFFING
Physicians:
1 Principal Investigator (Humberto Cruz, D.O.)
2 Sub Investigators: (Syed I. Ali,MD,FAC,FCAI) (Rita Rahbany, MD)

Research Staff:
A Research Director.: (Maria Lopez)
6 Full time Research Coordinators trained on 24 hour Masterscope/PK samples.
1 LPN, Clinical Research Coordinator.
2 Certified Clinical Research Coordinators.
3 Clinical Research Coordinators with more than 10 yrs. experience.

1 Full Time Recruiter and 3 Research Assistants

1 Full Time Lab Technician IAATA Certified

1 Full Time Research Manager (Regulatory Specialist/Quality Assurance)
All Research staff trained in EDC, GCP, NIH, CITI, and IAATA certified for shipping dangerous goods, ACRP training


SECURITY:

FICResearch is fully secured by a monitored central alarm system. All research offices have individual locking doors. Investigational product is stored under double lock with key pad lock.
24 hour security cameras.

SOP:

Site SOP is available upon request.

EMR:

FICResearch features state of the art technology to manage medical record and we are fully integrated HIPAA compliant.


DEMOGRAPHIC INFORMATION:

Demographics of subject population:

40% Male
60% Female
33% Caucasian
5% African American
57% Hispanic
5% Other
Our patient demographics are fairly mixed, including a large number of Hispanics and female patients. Most of our patients are insured and not active drug users.

EQUIPMENT:

The following items and or equipment are found on site at our facility:

Electrocardiogram*
o Hewlett Packard (Page writer 200i)

Centrifuge*
o Hamilton Bell (VanGuard V6500)
o Refrigerated Centrifuge -Thermo Scientific (IEC CL30R)

10 Exam rooms / 5 Patient Sleeping Suites for any 24 hour stay / 2 sleep Techs

4 Full Bathroom with Shower

NorLake Scientific -20 Degrees Celsius Locking Freezer

Locked Refrigerator

4 Polysomnography Computers with:
o Grass Telefactor Software (Version 4.3.1)
o Grass Telefactor Comet Head Box (AS40 Amplifier System)

Double Locked Medicine Room

Phase I Unit

EpiPens

Defibrillator*
o Welch Allyn (AED+10)

Internet (High Speed)

Our Website is www.ficresearch.com

* This equipment is calibrated once a year. Relevant documentation is provided upon request


Helpful Websites and other information:


http://www.urbanspoon.com/ps/26/9268/Orlando/Landmarks/Lee-Vista-Center.html

SITE CONTACT INFORMATION:

Maria Lopez
Research Director
Contracts/Budg

Study Search 

  • Vertis

    Merck/Pfizer MK-8835-004-01/B1521021: “RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP STUDY TO ASSESS CARDIOVASCULAR OUTCOMES FOLLOWING TREATMENT WITH ERTUGLIFLOZIN (MK 8835/PF 04971729) IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED VASCULAR DISEASE, THE VERTIS CV STUDY”

  • NN1250-4252

    A trial comparing the efficacy and safety of insulin degludec
    and insulin glargine 300 units/mL in subjects with type 2
    diabetes mellitus inadequately treated with basal insulin with
    or without oral anti-diabetic drugs

  • PT009003-03

    A Randomized, Double-Blind, Parallel Group, Multi-Center Study to
    Assess the Efficacy and Safety of PT009 compared to PT005 in
    Subjects With Moderate to Very Severe COPD

  • TD-4208-0149

    A Phase 3b, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Study to Compare Once Daily Nebulized Revefenacin with Spiriva Once Daily Delivered via the HandiHaler® on Lung Function in Subjects with Chronic Obstructive Pulmonary Disease and a Low Peak Inspiratory Flow Rate

  • GSK201749 Emax study

    A 24-week treatment, multi-center, randomized, double-blind,
    double-dummy, parallel group study to compare
    Umeclidinium/Vilanterol, Umeclidinium, and Salmeterol in
    subjects with chronic obstructive pulmonary disease (COPD)

  • CTT116855 – IMPACT STUDY

    A phase III, 52 week, randomized, double-blind, 3-arm parallel
    group study, comparing the efficacy, safety and tolerability of
    the fixed dose triple combination FF/UMEC/VI with the fixed
    dose dual combinations of FF/VI and UMEC/VI, all
    administered once-daily in the morning via a dry powder inhaler
    in subjects with chronic obstructive pulmonary disease

  • HZC112206:

     A 24-Week Study to Evaluate the Efficacy and Safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder and the Individual Components Delivered Once Daily (AM) Via a Novel Dry Powder Inhaler Compared with Placebo in Subjects with Chronic Obstructive Pulmonary Disease (COPD)

  • GSK204983

    An open-label study to evaluate the preference attributes of the ELLIPTA™ dry powder inhaler (DPI) compared to the HandiHaler™ DPI in subjects with Chronic ObstructivePulmonary Disease (COPD)”(study number 204983) (the “Study”)

  • TD-4208-0128

    A Phase 3, 52-week, Randomized, Active-Controlled Parallel Group Study to Evaluate the Safety and Tolerability of Nebulized TD-4208 in Subjects with Chronic Obstructive Pulmonary Disease

  • NN1250-4419

    A randomised, cross-over, open-label, multi-centre trial comparing the effect of
    insulin degludec and insulin glargine 100U/mL, with or without OADs in subjects with type 2
    diabetes using flash glucose monitoring

  • ASCENT Trial LAS-MD-45 (D6560C00002)

    Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase IV Study to
    Evaluate the Effect of Aclidinium Bromide on Long-term Cardiovascular Safety
    and COPD Exacerbations in Patients with Moderate to Very Severe COPD
    (ASCENT COPD)

  • Golden 5 trial SUN 101-303

    A Randomized, Open-Label, Active-Controlled, Parallel-Group, Multicenter, Long-Term Safety Trial of Treatment with Nebulized SUN-101 in Patients with COPD: GOLDEN-5 (Glycopyrrolate For Obstructive Lung Disease Via Electronic Nebulizer)” 

  • Golden-3 trial SUN101-301

    A Randomized, Double-Blind Placebo-Controlled, Parallel-Group, Multicenter, Efficacy and Safety Trial of 12 Weeks of Treatment with Nebulized SUN-101 in Patients with COPD: Golden-3 (Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer

Information

Demographic Data

  • SITE INFORMATION 
  • Start year clinical research2009
  • Phases of clinical studiesPhase I, Phase II, Phase III, Phase IV
  • Types of studiesBiologics, Drugs, Medical Devices, Vaccines
  • PopulationsAdolescent 11-17 yrs, Adult 18-64 yrs, Senior 65 yrs and over
  • SPECIFIC SITE INFORMATION 
  • Type of siteFreestanding
  • # of employees involved in research12
  • # of investigators3
  • Number of studies last year42
  • Days openMonday, Tuesday, Wednesday, Thursday, Friday, Saturday
  • Extended office hoursYes
  • Overnight facilitiesYes
  • Dry iceYes
  • Blinded pharmacistYes
  • Dedicated monitoring spaceYes
  • Internet access for the monitorYes
  • Onsite laboratoryYes
  • Central laboratoryYes
  • Infusion capabilityYes
  • Shipping optionsFedEx, UPS, DHL
  • REGULATORY INFORMATION 
  • Contact for regulatory documentsMaria Lopez
  • Regulatory phone number407658-0966
  • # of days to turn around regulatory documents3 days
  • Type of IRB used by this siteCentral
  • Appropriate storage facilities for productYes
  • Able to appropriately store Schedule II drugsYes
  • FINANCIAL INFORMATION 
  • # days to turn around budget and contract1 week