Therapeutic Areas

Dermatology
Endocrinology
Healthy Volunteers
Immunology
Infections and Infectious Diseases
Neurology
Ophthalmology
Pharmacology/Toxicology
Psychiatry/Psychology
Pulmonary/Respiratory Diseases
Sleep

Center Overview

As a small contract research organization, Clinilabs specializes in early phase and specialty studies. However, there is a giant within. We offer teams, processes, and technology solutions that can be scaled to meet project needs. We give early phase programs expert attention, and provide specialty services for later phase studies that fill the service gaps of other organizations. We have worked with top 20 pharma companies and biotechs, and count five of the top 10 CROs among our best clients.

It’s About The People
A successful clinical drug development program depends on assembling a team that delivers. We take pride in doing that at Clinilabs. Being located in New York, we work within the largest concentration of academic institutions in the world, in a city that is home to the largest bioscience workforce in the country. This environment enables us to hire the best and brightest people in the industry; those who share our clients’ vision and mission for every project, and who are dedicated to delivering high quality service. Every success is built on the spirit of collaboration and relationships that last.

Reliable Processes Are Our Foundation
We’ve done our homework when it comes to creating a formula for successful clinical development programs. Our company was founded by a clinician and scientist who learned how to take new drugs from bench to bedside. His knowledge, combined with that of our experienced drug development team, has enabled us to create an encyclopedic library of standard operating procedures (SOPs). These SOPs ensure that studies are professionally managed, and that deliverables are provided on time and within budget. The proof of performance? Eighty-five percent of our clients are frequent repeat customers and we’ve helped them take 9 new drugs through successful NDAs and to market.

Trust But Verify
Experienced clinical teams know that you have to sweat the small stuff. The collection of clinical trial data is not enough - data must be verified. That is why our quality assurance and compliance team conducts quality control checks, and performs internal and external audits that confirm the integrity of the work that we do. We exceed the audit expectations of our big pharma clients, and our quality systems withstand regulatory scrutiny. A 2009 routine audit report issued by the US Food and Drug Administration for a multinational study we conducted indicated no observations.

More For Less
In today’s economy clients must demand service at the lowest cost possible. At Clinilabs we respond to this demand by offering budgets that beat our domestic competitors, and we understand that low prices are no excuse for compromised service. We’ve developed workflow models and technology tools that streamline our work while providing unparalleled levels of service. A recent case study published by Microsoft revealed that our processes reduce clinical trial costs by up to 35% - leaving our clients with resources that can be applied to other development objectives. Our clients already know that "preferred providers" may not offer the advantageous pricing and services found at Clinilabs.

Clinical Research Experience

Investigators at Clinilabs have conducted more than 200 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, 50-bed clinic in Manhattan, which offers an ideal location for timely recruitment of healthy volunteers, special populations, and patients or at our 50-bed early phase unit in Eatontown, NJ. 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.

Clinilabs offers a full portfolio of data services for early-phase studies and specialty data services for Phase III trials. Single and multicenter projects are managed by an experienced team of professionals with expertise in data acquisition and processing. Traditional data services include double data entry, query generation and resolution, adverse event tracking, medical coding, biostatistics, and medical writing. Electronic data services include EDC and customized Clinical InSite™ eRooms that provide a location for shared clinical trial documents. Clinical InSite™ additionally allows sponsors, monitors, and auditors to have remote, real-time access to files. Low cost data management solutions are available as a result of our global strategic alliances, which bring the efficiencies of an Asian labor force to US managed projects.

Areas of interest and expertise include:

• Central Nervous System (CNS)
• Specialty in Sleep Disorders
• Cardiology
• Cardiac Safety
• Endocrinology
• Dermatology
• Immunology/Infectious Diseases

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

Facility Description

Clinilabs' Midtown Manhattan’s Clinical Research Unit (CRU) features the following attributes:

• Custom-built, state-of-the-art, 32,000 sq. ft. facility in Midtown Manhattan, near transportation hubs
• 50-bed Phase 1 unit
• Active database of subject candidates, recruited from a population of >19 million people
• 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
• Cognitive and computerized cognitive assessment, with full-time psychometrist
• Staffed pharmacy on site
• Secure, temperature-controlled drug storage
• CLIA-waived clinical laboratory on-site, with high capacity centrifuges and freezers
• Board-certified ACLS physicians and nursing staff
• Emergency medicine physician and equipment on site, including stocked crash cart and AED; emergency room within 0.3 miles
• Rapid reviews by central IRB

Clinilabs’ Eatontown, NJ Clinical Research Unit (CRU) features the following attributes:

• First in human
• Dose ranging, single ascending dose (SAD)
• Dose ranging, multiple ascending dose (MAD)
• Bioavailability (BA)
• Bioequivalence (BE)
• Pharmacokinetic (PK)
• Pharmacodynamic (PD)
• Drug and food interaction
• Blind dosing/sampling

Highlights:

• 50-bed Capacity
• Clinical Laboratory
• Pharmacy
• Ideal accomodations for Ethnic Bridging studies

Investigator Experience

Clinilabs 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 600 investigators in 32 countries.

Patient Demographics

Clinilabs maintains a database of more than 60,000 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. We also use the following tactics to ensure that we meet enrollment goals and timelines:

Other Information

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, UK, France, Germany, and Japan.

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