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Research Center Profile:
Clinilabs, Inc.

Center Information

Clinilabs, Inc.
423 West 55th Street
New York, NY 10019
USA
646-215-6400
646-215-6401 (fax)
info@clinilabs.com
www.clinilabs.com/
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Contact Center

Therapeutic Areas

Cardiology/Vascular Diseases
Dermatology
Devices
Endocrinology
Family Medicine
Gastroenterology
Healthy Volunteers
Immunology
Infections and Infectious Diseases
Musculoskeletal
Nephrology
Neurology
Nutrition and Weight Loss
Obstetrics/Gynecology (Women’s Health)
Oncology
Ophthalmology
Pharmacology/Toxicology
Psychiatry/Psychology
Pulmonary/Respiratory Diseases
Sleep
Trauma (Emergency, Injury, Surgery)
Urology

Center Overview

INTRODUCTION

Clinilabs is a full-service contract research organization (CRO) that specializes in early-phase studies, from first-in-human to proof-of-concept, with normal healthy volunteers and patient populations. The company owns and operates two Phase I units in the US, and maintains a network of highly qualified investigator sites for multicenter Phase II studies Worldwide. Specialty projects, including pharmacodynamic, biomarker, cardiac safety, sleep/wakefulness, metabolic, and Japanese bridging are among our strengths. Clinilabs is recognized globally as a leading specialty CRO, offering an alternative to large CROs for specialty projects. For more information, please visit www.clinilabs.com.

CLINICAL DEVELOPMENT SERVICES

Clinilabs offers a full range of Phase I and Phase II clinical development services. We specialize in managing single-center and multi center Phase I and II studies in a wide range of therapeutic areas, conducted at investigator sites on five continents. Our team has experience in over 1,000 clinical trials in the following therapeutic areas:

  • Infectious Disease: HIV, Hepatitis C
  • Cardiology: Heart Failure, Hypertension, Hypotension, Hypercholesterolemia
  • Oncology
  • Endocrine and Metabolic: Diabetes, Obesity, Binge Eating
  • Neurological Disorders: Parkinson’s Disease, Epilepsy, Alzheimer’s Disease, Traumatic Brain Injury
  • Psychiatric Disorders: Depression, Bipolar Disorder, Schizophrenia, Generalized Anxiety Disorder
  • Pain and Inflammation: Osteoarthritis, Rheumatoid Arthritis
  • Pulmonary Disease: Asthma, COPD
  • Dermatology: Psoriasis, Rheumatoid Arthritis
  • Rare Disorders: Congenital Blindness, Hereditary Inclusion Body Myopathy, Narcolepsy, Symptomatic Orthostatic Hypotension
  • Sleep Disorders: Insomnia, Sleep Apnea, Narcolepsy, Restless Legs Syndrome, Shift Work Sleep Disorder, Jet Lag
  • Sexual and Reproductive Disorders: Male Erectile Dysfunction
  • Women’s Health: Menopause

CORE LABORATORIES

Clinilabs is a leading provider of core laboratory services for clinical trials, offering a high performance platform that connects investigator sites and sponsors around the world to a validated and secure electronic data environment in the United States. Our core data center hosts seven core laboratories that provide clinical trial services.

  • ECG
  • EEG/QEEG
  • PSG
  • EMG
  • Actigraphy
  • Home Sleep Testing (HST)

Clinilabs’ core laboratories offer industry-leading operational expertise, physical and electronic security systems, and a high-performance network infrastructure to enable the centralized capture and processing of clinical trial data. The core laboratories provide clients with a turnkey solution, and offer investigator site qualification, device management, study-wide SOPs, centralized processing with rapid turnaround time, and 24/7 helpdesk. Many of our staff members are bi-lingual, enabling us to communicate with sites in Europe, Eastern Europe, Asia, and Latin America in their native languages.

CLINICAL RESEARCH UNITS

Clinilabs' Midtown Manhattan and Eatontown, NJ Clinical Research Units (CRUs) feature the following attributes:

  • Custom-built, state-of-the-art, 50-bed facilities offering access to 100 beds over all
  • Convenient locations in New York City and New Jersey, close to transportation hubs
  • Active database of subject candidates, recruited from a population of >19 million people
  • Secure, locked units with clinical laboratories and pharmacies
  • Ideal accommodations for Ethnic Bridging Studies
  • PK, PD, BA, BE study experts
  • First-in-human studies
  • Single ascending dose (SAD) and multiple ascending dose (MAD) studies
  • Laboratory-based and neuroendocrine biomarker studies
  • Food interaction and drug-drug interaction studies
  • Cardiac safety and cardiac intensive studies, with Mortara Surveyor telemetry for TQT
  • EEG, quantitative EEG, EMG, Actigraphy, and PSG studies
  • Pupillometric analysis studies
  • Driving simulator studies
  • Blind dosing and blind sampling studies
  • Metabolic control studies, including glucose monitoring and calorimetry
  • Imaging studies, including PET, in collaboration with local imaging center with cyclotron

Clinical Research Experience

Clinilabs’ Phase I units have conducted over 400 trials in a variety of therapeutic areas. Complex Phase I and proof-of concept studies can be conducted at Clinilabs’ state-of-the-art, 50-bed units in Manhattan and Eatontown, NJ, which offer an ideal locations for timely recruitment of healthy volunteers, special populations, and patients.

POPULATIONS AND THERAPEUTIC EXPERIENCE

  • Healthy Adult Volunteers
  • Healthy Elderly Volunteers
  • Poor Metabolizers
  • Japanese Volunteers and Patients
  • Chinese Volunteers and Patients
  • Rare Disorders
  • Recreational Drug Users
  • Psychiatric Disorders
    • Depression
    • Treatment Resistant Depression
    • Bipolar Disorder
    • Anxiety Disorders
    • Eating Disorders
    • Substance Use Disorders
  • Neurological Disorders
    • Alzheimer's Disease
    • Mild Cognitive Impairment
    • Epilepsy
    • Parkinson's Disease
  • Pulmonary Disease
    • Asthma
    • Allergy
    • COPD
  • Endocrine and Metabolic disorders
    • Diabetes
    • Obesity
  • Infectious Diseases
    • HIV
    • Hepatitis C Patients
    • Hepatitis B Patients
  • Dermatological Disorders
    • Psoriasis
    • Rosacea
  • Men's and Womens’ Health
    • Erectile Dysfunction
    • Menopause

SPECIALTY PROCEDURES

  • Cardiac and Pulmonary Assessments
    • Holter and Continuous Holter Telemetry
    • QT Interval Assessment
    • Spirometry
    • Pulmonary Functions Testing
    • Respiratory Indcutance Plethysmography
    • Pulse Oximetry
  • Sleep and EEG Monitoring
    • Polysomnography
    • MSLT
    • MWT
    • EEG and Evoked Potentials
    • Seizure Monitoring
    • Actigraphy
    • Dexa Scanning
  • Metabolic Assessments
    • Calorimetry
    • Doubly-Labeled Water
    • Glucose Tolerance Testing
    • Anthropomorphic Measurements
  • Cognitive Assessments
    • Computerized Testing
    • Reaction Time Assessment
    • Sedation Assessment
    • Body Sway
    • Computerized Dynamic Posturography
    • Driving Simulator
  • Biomarker Assessments
    • CSF
    • cCSF
    • QEEG
    • Imaging
    • Hormones
    • Laboratory-based Biomarkers
  • Other Procedures
    • Tissue Sampling
    • Pupilometry
    • Hemodialysis
    • Ketamine Models
    • Blister Models (Dermatology)

Facility Description

CLINILABS NY

CLINILABS NJ

Investigator Experience

Mardik Donikyan, D.O., Medical Director, NYC Specialty Pharma Unit
Mardik Donikyan, D.O., is board certi_ed in Emergency Medicine and has over 18 years of experience in this specialty. Mardi has served as aprincipal investigator for nearly 10 years and has extensive experience in Phase I studies with normal healthy volunteers, as well as patient populations. Mardi has conducted studies in patients with CNS disorders, cardiovascular disorders, metabolic disorders, infectious diseases, gastrointestinal disorders, dermatologic conditions, and rare diseases.

Magdy Shenouda, M.D., Medical Director, NJ Phase I Unit
Magdy Shenouda, M.D., is board certi_ed in Internal Medicine and serves as a principal investigator at the New Jersey Phase I unit. Magdy has 17 years of experience in Phase I research and has worked in many therapeutic indications, including CNS, hypertension, diabetes, cardiovascular disease and QTc studies, and invasive studies. Magdy has extensive experience managing intensive PK, BA, and BE protocols, as well as drug and food interaction studies.

Maha Ahmad, M.D., Principal Investigator
Maha Ahmad, M.D., is board certi_ed in psychiatry and sleep medicine. She completed a residency in psychiatry and a fellowship in child and adolescent psychiatry at New York Presbyterian Hospital, Weill Cornell Medical Center in New York, NY, and a fellowship at the Sleep Disorders Institute. Maha’s current research focus is on CNS disorders, including major depressive disorder, bipolar disorder, pediatric indications, attention de_cit disorder, and sleep disorders.

Sandra D. Comer, Ph.D., Principal Investigator
Dr. Sandra Comer is a Professor of Neurobiology in the Department of Psychiatry at Columbia University and a Research Scientist at the New York State Psychiatric Institute. She is the Director of the Opioid Laboratories in the Division on Substance Abuse and is an active member of the College on Problems of Drug Dependence. She has served on the Ethics Committee of CPDD and on the Program Committee of CPDD. In 2009 and 2010, Dr. Comer co-chaired meetings sponsored by the Initiative on Methods, Measurements, and Pain Assessment in Clinical Trials (IMMPACT group). She has published over 115 papers, chapters, and books on issues related to drug dependence.

Gary Zammit, Ph.D., Principal Investigator
Gary Zammit, Ph.D., is a clinician, scientist, and academician who founded Clinilabs in 2001. He has served as a principal investigator on more than 150 trials and has extensive experience in a wide array of CNS and metabolic disorders. Gary’s research involvement includes work in insomnia, sleep apnea, narcolepsy, periodic limb movement disorder, circadian rhythm disorders, mood disorders, including major depression and treatment resistant depression, mild cognitive impairment and Alzheimer’s disease, and diabetes.

Joseph Ghassibi, M.D., Principal Investigator
Joseph Ghassibi, M.D., is a fellow of the American College of Chest Physicians and the American Academy of Sleep Medicine. He is board certi_ed in pulmonary and critical care medicine, internal medicine, and sleep medicine. As a clinician and professor at the Columbia University College of Physicians and Surgeons, Joe has extensive experience in pulmonary functions testing. His clinical trial interests relate to asthma, COPD, and sleep-related breathing disorders.

Michael Werner, M.D., Principal Investigator
Michael A. Werner, M.D., is a board-certi_ed urologist who received fellowship training in male infertility and sexual dysfunction at Boston University Medical Center. His private practice o_ces in Manhattan, Westchester NY, and Fair_eld CT are focused on two areas of specialization: male infertility and male and female sexual dysfunction. In the past 10 years, Michael has been a principal investigator in over 20 studies related to Men’s or Women’s health and reproductive safety studies.

Admir Hadžic, M.D., Ph.D., Principal Investigator
Admir Hadžic, M.D., Ph.D., has been at the forefront of academic anesthesiology for nearly two decades. His research has substantially contributed to the development of functional regional anesthesia anatomy, standardized techniques of nerve blocks, patient outcome bene_ts of regional anesthesia, and monitoring principles to standardize the practice and decrease the risk of complications of nerve blocks. Admir leads our research activities in anesthesia and pain management and also provides expert support for CSF and cCSF studies.

Clinilabs also provides links to hundreds of investigator sites with early phase experience worldwide. Many of these sites have been certified, providing documentation that they are able to collect and transfer data in accordance with protocol specifications and Clinilabs’ SOPs. While we focus on early phase studies, the ability to network sites for participation in multicenter trials is one of our specialties. We have a database of more than 1,600 investigator sites, and we have worked with more than 700 investigators in 42 countries.

Patient Demographics

Clinilabs maintains a database of more than 70,000 people from a local population of >19 million who have expressed interest in clinical trial participation. This database includes normal healthy volunteers, clinical populations, and specialty populations. Candidate profiles are routinely updated to ensure that database reports represent an accurate indicator of our ability to enroll subjects into a study. Today, early phase projects often include cohorts of clinical patients. That makes it important for sponsors to select units that can effectively enroll these populations. At Clinilabs, we begin every project by mining our database of interested participants in order to pre-load studies.

Percentage of subjects by sex:

Female 54%
Male 46%

Percentage of subjects by race:

White 30%
African American 27%
Hispanic 13%
Asian 1%
Other 29%

Percentage of subjects by age group:

6-17 years .0025%
18-64 years 85%
65+ 14%

Other Information

ETHNIC BRIDGING

People of Asian descent can metabolize drugs differently than others. Therefore, Asian regulatory authorities may require absorption, distribution, metabolism, and excretion (ADME) data in Asian subjects before a drug is approved for marketing. Clinilabs’ Phase I units are located in regions that are home to the largest Asian population in the US who meet standard criteria for bridging studies, making them the world’s leading destinations for single- or multi-center Ethnic Bridging trials.

Subjects

  • Japanese healthy volunteers
  • Chinese healthy volunteers

Special Accommodations

  • Cultural accommodations
  • Multilingual staff
  • Foreign language translations of study documents

ABUSE LIABILITY

Clinilabs offers clients comprehensive human abuse liability assessment related services. Our team of world-renowned leaders in abuse liability and experts in clinical drug development have a deep understanding of current regulatory guidance for the assessment of relative abuse liability of investigational drugs and CNS compounds. Clinilabs assists customers in compiling a complete development plan for regulatory submission to the FDA, from protocol development and study execution to the clinical study report. Our clinical research units are ideally located in New York City and nearby Eatontown, NJ, providing access to one of the largest and most diverse populations in the world. Our extensive database of recreational drug users ensures rapid and efficient enrollment of qualified subjects.

RECRUITMENT

Clinilabs maintains one of the largest pipelines of research volunteers and patients in the industry, consisting of several thousand individuals who have previously expressed interest or participated in clinical trials. These individuals are pre-screened for willingness to endure the confinement and the medical procedures required by the trial. Clinilabs has a dedicated recruitment team consisting of 5 full-time and 1 part-time recruiters who are focused on database mining, handling of incoming responses to advertising, phone screening, scheduling of subjects for screening, and community outreach.

  • In-house call center
  • In-house Advertising and Marketing Department
  • Subject Authentication Program (SAP)

LEAN SIGMA CULTURE OF QUALITY PROGRAM

At Clinilabs, we take pride in offering highly trained and skilled people, time-tested procedures, and advanced technology to offer our clients a quality-driven culture called the “Culture of Quality.” This Culture relies on Lean Sigma processes, and has been designed to deliver quantifiably superior clinical trial results consistently, on time, and on budget.

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