Clinilabs’ mission is to provide high quality, prompt, and cost-effective services to its clients in the interest of delivering new therapeutics to those in need. As a specialty contract research organization (CRO), Clinilabs offers a full portfolio of clinical drug development services to its clients. These include all of the services sponsors expect from a premier CRO, encompassing multicenter project management, investigator and subject recruitment, clinical and medical monitoring, data management, biostatistics, and medical writing. One unique aspect of the Company is its core data center. This center offers the centralized capture of electronic source documents and case report forms (eCRFs), and the central reading of polysomnograms (PSGs), electroencephalograms (EEGs), and electrocardiograms (ECGs) for multicenter trials.

Investigators at Clinilabs have conducted more than 170 Phase I - IV trials in a variety of therapeutic areas.

Complex Phase I and proof-of concept studies can be conducted at Clinilabs’ state-of-the-art, 60-bed clinic in Manhattan, which offers an ideal location for timely recruitment of healthy volunteers, special populations (e.g., Japanese and Chinese), and patients. In addition, pharmacokinetic, pharmacodynamic, and biomarker studies, as well as those that require thorough QT or specialized cardiac assessment, are areas of Clinilabs’ expertise.

Clinilabs conducts Phase II trials using small samples of patients or larger groups of healthy subjects studied using experimental models. For example, Phase II studies of insomnia may include studies of patients with chronic insomnia, or the use of experimental models of transient insomnia in healthy subjects in which laboratory adaptation effects, phase-advanced bedtimes, or noise perturbations are employed. Clinilabs maintains a large database of healthy volunteers, as well as those with chronic insomnia, shift-work sleep disorder, obstructive sleep apnea, narcolepsy, depression, anxiety, and other psychiatric and neurological conditions.

Clinilabs is a top-performing site for multicenter pivotal trials for sponsors developing drugs for sleep, psychiatric, neurologic, and cardiac indications. Patients are recruited into trials from the Company’s database and from local clinical settings, as well as through advertisements. Careful attention is given to the selection of qualified research candidates who meet study inclusion/exclusion criteria. Our clinical site metrics indicate high enrollment, accrual, and retention rates, coupled with low rates of queries, protocol deviations, or protocol violations. Numerous sponsor audits have confirmed our exceptional performance.

Clinilabs has extensive experience in Phase IV trials, including those that involve quality-of-life assessments, label enhancements, and the development of new formulations, patent extensions, supplemental new drug applications (sNDAs), and 505(b)(2) development programs.

The Company also offers specialty services for complex PD studies, such as those that involve the collection of mood, cognition, psychomotor functioning, EEG, quantitative EEG, evoked potential (EP), and imaging data.

The Company’s Multicenter Trial Division provides eCRF, electronic device data (such as ECG, EEG, PSG, and actigraphy), and electronic subject recruitment and enrollment services through proprietary platforms that are compliant with 21 CFR Part 11. The Clinilabs Data Center is a leading data management resource throughout the industry.

Areas of interest and expertise include:

• Central Nervous System (CNS)
• Specialty in Sleep Disorders
• Cardiology
• Cardiac Safety
• Endocrinology
• Oncology

Please note, our multi-center services including data management, EDC, and patient recruitment, are available in any therapeutic area.

The Company’s state-of-the-art clinical research facility in Manhattan can accommodate up to 60 patients at one time, offering the highest level of service available in the industry today. On site administrative, clinical, and regulatory staff speed the execution of sponsors’ projects. CLIA-certified laboratories provide a variety of services for Phase I, safety, cardiac safety (QT and thorough QT), and proof-of-concept trials.

Clinical Trial Site Services Division: Clinilabs’ main office and laboratories are located in midtown Manhattan. This modern 24,400 sq. ft. facility contains professional offices, conference room, extensive monitoring facilities, examination rooms, testing rooms, meal facilities, restroom/shower facilities and private or shared rooms suitable for overnight stays, including sleep studies. An impressive array of equipment is available, including analog and digital EEG, EMG, EKG instrumentation; cardiac monitoring equipment; psychometric testing stations; and audio/video recording devices. Our CLIA-certified laboratory is available for processing, storing, and shipping biological samples, including samples that require low and ultra-low refrigeration. Compounding pharmacy, imaging (MRI, CT, PET), and other services may be obtained locally from one of our affiliated hospitals.

Comfortable space with telephone, Internet access, copier, fax, and meal access is provided for study monitors. A local hotel provides preferred rates for Clinilabs’ visitors. Multicenter Trial Division: located on the upper West side of Manhattan, contains professional offices and state-of-the-art data center for electronic clinical trials data. Systems are 21 CFR Part 11 compliant; providing a central point for the management and storage of all study data including eCRF, clinical laboratory, medical device, IVRS, and diary data.

Electronic subject recruitment and enrollment services, electronic enrollment logs, and Web-based trials are managed through facilities at both of Clinilabs’ locations. A call center is located at the midtown location.

Clinilabs’ facility is an ideal location for Phase I studies in any therapeutic area, including PK, PD, BA, BE, drug interaction, and food interaction studies.

• State-of-the-art facility in midtown Manhattan near transportation hubs
• 20 dormitory rooms that can accommodate up to 60 subjects
• Open 7 days a week, 24 hours a day
• Secure, locked unit with 24-hour video surveillance
• Telemetric monitoring and recording systems designed for continuous subject monitoring, including Mortara cardiac monitoring devices
• Environmentally controlled suites
• On-site research pharmacy with pharmacist on staff
• CLIA-waived laboratory tests performed on-site
• Centrifuge and high-speed refrigerated centrifuge
• Low (-20 degrees) and ultra-low (-86 degrees) digitally monitored refrigeration of biological samples
• Secure, temperature-controlled drug storage, IV infusion capability
• On-site emergency equipment: crash cart, automatic external defibrillator (AED), nearest emergency room three blocks away
• Patient kitchen and day room
• Private rooms for monitors with high-speed Internet access
• Locked, fire-resistant file storage
• Back-up power source

PHASE II / IV, CNS, AND CV FACILITIES

Clinilabs’ investigator site is designed to meet the needs of clients who wish to conduct Phase II – IV studies in CNS and CV areas.

• Custom-built, state-of-the-art facility in midtown Manhattan near transportation hubs
• Comfortably furnished and carpeted consulting offices
• Modern, clean examination rooms and equipment
• Well-appointed patient rooms and environmentally controlled suites
• Analog and digital electrocardiographic ECG, PSG, EEG, or EMG recording equipment
• Advanced diagnostics (e.g., cognitive assessment, imaging, cardiac monitoring)
• On-site pharmacy
• CLIA-waived laboratory tests performed on-site
• Centrifuge and high-speed refrigerated centrifuge
• Low (-20 degrees) and ultra-low (-86 degrees) digitally monitored refrigeration of biological samples, with dry ice manufacturing facilities
• Staff certified to handle biological specimens (hazardous materials)
• Locked, video-monitored, and temperature-monitored drug storage
• Locked, fire-resistant file storage
• Site security that includes closed-circuit security cameras, digital entry system, security personnel on-site, and monitored alarm system
• Full medical emergency equipment, including fully stocked crash cart and automatic external defibrillator (AED)
• Site server and applications compliant with 21 CFR Part 11
• Telemetric monitoring and recording systems designed for continuous subject monitoring, including Mortara cardiac monitoring devices
• Electronic data capture capabilities for single- or multi-center clinical trials
• In-house “call center” for recruiting research participants for single- or multi-center clinical trials
• Back-up power source

Clinilabs recognizes that client companies often rely on key opinion leaders (KOLs) to guide their drug development programs. That is why we employ some of the world’s leading scientists in the fields of CNS and CV therapeutics. Our scientists work alongside KOLs from academia and industry to ensure that clients are able to base their development programs on sound advice, and carry these programs forward with expert guidance.

Clinilabs maintains relationships with an extensive network of qualified CNS and CV investigators worldwide. These investigators, many of whom are leaders in their respective fields, provide an invaluable resource to sponsor companies. Information related to site characteristics, capabilities, and proficiencies enable sponsors to select sites that best suit their needs. One distinguishing characteristic of Clinilabs’ investigators is their exceptional training. All investigators and study staff registered in the Clinilabs database are eligible to receive continuing education (CE) credits through the Company’s clinical research training program. Clinilabs is dedicated to providing free-of-charge, Web-based training to investigators who register with the Clinilabs’ investigator database. Training is approved for continuing education (CE) credits for investigators and their staff members.

Clinilabs now offers the following training modules for research personnel at investigator sites:

• GCP
• HIPAA
• 21 CFR Part 11
• Informed Consent Process
• Serious Adverse Event Reporting

The investigators at Clinilabs are supported by a staff that includes nurse practioners, physicians’ assistants, research assistants, laboratory technicians, medical office assistants, clinical research recruiters, and clerical personnel.

All Clinilabs employees are dedicated to high quality service and patient care.

Clinilabs offers a proprietary, Web-based patient recruitment service that provides a unique and compelling solution to recruitment challenges. This system reaches the >60% of adults who seek health-related information on the Internet. Clinilabs’ banner ads, message board listings, and placements on commonly used search engines drive potential subjects to study-specific Web sites where they are efficiently pre-screened using automated questionnaires. Those who appear to meet enrollment criteria are immediately connected to our call center or to investigator sites in their geographic areas. Electronic tracking and enrollment logs keep local sites in charge of their recruitment activity. The efficiency of Clinilabs’ system enables the Company to guarantee that its centralized subject recruitment programs will be implemented at significantly less cost than traditional recruitment programs.

Populations represented in Clinilabs’ large subject database include, but are not limited to, healthy adult, healthy elderly, Japanese, Chinese, renal-impaired, and hepatic-impaired people, as well as individuals with histories of alcohol and substance abuse.

Clinilabs’ investigator site services division provides a wide range of clinical development services that enable clients to successfully complete Phase II – IV studies of CNS and CV therapeutics. Sponsors who place studies at Clinilabs’ investigator site in Manhattan are able to recruit patients from the large clinical trial database that the Company has been developing since 2001. This database includes more than 32,000 local residents who have expressed interest in participating in clinical research. Included in the database are clinical patients who meet criteria for a wide variety of cardiovascular, psychiatric, neurological, and endocrine disorders.

Clinilabs uses centralized IRB services.

Scientific writing is available and includes the preparation of clinical study protocols and clinical study reports.

Clinilabs has a large national database of subjects who meet key entry criteria in various therapeutic areas.

Clinilabs provides centralized data management services including centralized PSG, centralized EEG/Safety Studies, centralized ECG, centralized actigraphy, and electronic data capture (EDC).

Multicenter trials have been managed in the United States, Canada, France, Germany, and Japan.

CenterWatch is listing the following trials that are actively recruiting patients at this center.

• A double-blind, randomized, parallel group, placebo controlled, sleep laboratory efficacy and safety study with Org 50081 in elderly subjects with chronic primary insomnia.
• A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, 3-Period Crossover, Adaptive Dose Design, Clinical Trial to Evaluate the Safety and Efficacy of MK-0249 in Treating Refractory Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea/Hypopnea Syndrome Appropriately Using Nasal Continuous Positive Airway Pressure (nCPAP) Therapy
• A RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, PLACEBO-CONTROLLED, MULTICENTER OUTPATIENT TRIAL OF PD 0200390 IN ADULTS WITH PRIMARY INSOMNIA
• A randomized, double-blind, placebo-controlled, subjective study to assess the efficacy of APD125 in patients with primary insomnia characterized by difficulty maintaining sleep.
• A single-blind, placebo-controlled sleep laboratory study of the acute effects of an investigational medication in Restless Legs Syndrome.
• Ascending single-dose study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of GSI-136 administered orally to healthy young and healthy elderly subjects.
• Efficacy and safety of 2mg/day of M100907 on Sleep Maintenance Insomnia with a sub-study of the effect of M100907 on stable Type II Diabetes Mellitus: a 12-week, multi-center, randomized, double-blind, placebo-controlled study

For more information, please contact:

Gary K. Zammit, Ph.D.
President & CEO
Clinilabs, Inc.
423 W. 55th Street, 4th Floor
New York, NY 10019 USA
Phone: 212-994-5100
Fax: 212-994-5101
E-mail:

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

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Last updated on August 21, 2008