Fieve Clinical Research, Inc.

Center Information

Vanessa Fieve
Site Director/President
Fieve Clinical Research, Inc.
122 East 42nd Street, Suite 2820
New York, NY 10168
USA
212-772-3570
212-772-3550 (fax)
info@fieveclinical.com
View Map

Contact Center

Currently Enrolling Trials

[Show More]

Therapeutic Areas

Endocrinology
Internal Medicine
Neurology
Nutrition and Weight Loss
Psychiatry/Psychology
Sleep
Vaccines

Center Overview

Fieve Clinical Research, Inc. (FCR) is a dedicated research center with over 20 years of experience located in the heart of New York City, mid-town Manhattan, next to Grand Central Station. Managed by Vanessa Fieve, JD, CCRC, FCR participates in Phases II, III, and IV outpatient clinical trials and has worked with over 50 pharmaceutical companies and CROs. Principal Investigators at FCR are all board certified with 5+ years of experience conducting clinical trials.

Performance Metrics

Number of Studies Conducted: 200+
Number of Active Patients in the Database: 1000+
Average Number of Total Patients Enrolled: 80
Average Percent of Total Patients Randomized: 75%
EDC Capabilities: Yes

Staff Certifications
Number of Certified CRCs: 3

ACRP Certifications
Number of ACRP Certified CRCs: 1
Number of ARCP Certified PIs: 1

Clinical Research Experience

The areas in which FCR conducts research span across Psychiatry and Neurology. Staff have combined experience in facilitating 480+ clinical studies.

List of specialties:
  • Attention Deficit Hyperactivity Disorder
  • Anxiety Disorders
  • Bipolar Disorder
  • Chronic Fatigue Syndrome
  • Chronic Pain
  • Depression (MDD) and Dysthymia
  • Dry Eye
  • Diabetic Neuropathy
  • Fibromyalgia
  • Gout
  • Hypertension
  • Hypercholesterolemia
  • Insomnia
  • Lower Back Pain
  • Migraine Headaches
  • Mild Cognitive Impairment
  • Obsessive Compulsive Disorder
  • Obesity
  • Osteoarthritis
  • Panic Disorder
  • Post Herpetic Neuralgia
  • Psoriasis
  • PTSD
  • Restless Leg Syndrome
  • Seasonal Affective Disorder
  • Smoking Cessation
  • Social Anxiety Disorder
  • Treatment Resistant Depression
  • Vaccine

This outpatient clinic facility has been involved with clinical research for 20+ years. FCR is focused on continuous training supported by a well-established program that documents orientation as well as clinical and laboratory performance assessments. The training program is position-focused and includes study-specific training. The training materials are aligned with CFRs, ICH and GCP guidelines, ensuring that all levels of FCR staff understand compliance with the regulations. Training does not end with a new employee’s orientation, but is an ongoing monthly program giving FCR the leading edge in knowledge and expertise. There are weekly staff internal meetings ensuring cross training and maintaining current updates on study/subject developments. Certifications are available upon request.

Facility Description

FCR is a premiere outpatient clinical research site. The facility itself is a 1800 sq ft office space located in the historical Chanin Building on the corner of 42nd Street and Lexington Avenue (the intersection of most NYC bus lines, and subways and trans in and out of Grand Central station).

The space includes 4 private patient interview offices, 1 monitor office, 1 laboratory/examination room, and 1 waiting room with cable television. FCR's laboratory equipment is calibrated annually by an independent biometrics company. It includes digital and manual blood pressure device and weight scales, ambient and refrigerated centrifuge, and -25° F freezer.

There is ample storage space for study lab kits, access to dry-ice and courier pick-up service daily. Also, there is a stainless 2-8°C refrigerator that is temperature monitored and secured by a stainless steel Pad-Lock. Fully equipped laboratory set up for venipuncture IV infusions and injections.

The clinic has secure WiFi connection throughout the office along with up-to-date fax machine, scanners, and computers. A continually updated and secured CRM Software holds our growing database of current and past subjects across various therapeutic areas for future prospective studies.

Investigator Experience

Dr. Paul Eder- Board Certified in Psychiatry; Principal Investigator who has conducted trials across multiple disease areas including ADHD, Bipolar, Fibromyalgia, GAD, MDD, Migraines, and Restless Leg Syndrome

Dr. Craig McCarthy- Board certified in Psychiatry; Principal Investigator of Pennsylvania site with 18+ years of clinical research experience

Dr. Mars Gunja- Board Certified in Psychiatry; Sub-investigator on all ongoing clinical studies

Staff Expertise

Research staff at FCR includes the site manager, certified study coordinators, data entry specialists, patient recruitment specialists, lab technicians, and quality assurance specialists. FCR has written Standard Operating Procedures (SOPs) to ensure that trials are conducted and data are generated, documented, and reported in compliance with the protocol, GCP, confidentiality (including HIPAA) and the applicable regulatory requirement(s). Each employee is required to be trained on the FCR SOPs and ICH-GCP guidelines prior to being assigned a study. In-service training is conducted annually to remind the researcher of proper research techniques, the confidentiality of patients and research protocol, and the importance of minimizing placebo effect in clinical trials. A record of the training in the form of printed certificates is kept on site in the regulatory binders and the staff binders. Staff capabilities include a variety of training with respect to IATA, phlebotomy, and rating scales (SCID, MINI, HAM-D, etc.).

Patient Demographics

FCR has access to an extensive patient population in all 5 boroughs of New York City, as well as greater New York, New Jersey, and Connecticut. The population is quite diverse across FCR's psychiatric and neurological patient reach. Patient recruitment utilizes a multifaceted approach through internal databases, referrals, print advertising, digital advertising, community outreach, and, at times, television/radio advertising.

Other Information

FCR uses a central IRB and is known for strictly observing GCP guidelines, FDA regulations, and protocol criteria while meeting deadlines and maintaining a high patient recruitment and retention rate.

Contact Center

If you are interested in contacting this center to discuss placing a clinical trial there, please complete and send the email form below. A representative from the research center will then follow up with you.