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 35,000 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.
Phase II trials typically form the basis for a sponsor’s “go” or “no-go” decisions regarding drugs in development. Clinilabs conducts these 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.
Post-marketing research may include studies that serve to enhance product labeling or identify new indications. 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.
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