Our research centers rely on highly sophisticated and rigorous Clinical Operating Guidelines and procedures. With a proactive approach toward patient care and research quality, CCT conducts self-audits and welcomes third party performance reviews. We’re proud of our reputation for integrity and performance but we continue to strive to be the best in drug research and testing.

Whether CCT conducts a Phase I Early Drug Development program, sleep polysomnography study, or Phase II-IV clinical trial, we regularly meet or exceed a Sponsor's timeline to complete patient enrollment. And we deliver clean data that’s ready for database lock.

Contact CCT and discuss what our world-class track record can do for your study.

Click on the areas below to learn more about CCT's superior performance capabilities.
EARLY DRUG DEVELOPMENT/PHASE I
PHASE II-IV CLINICAL RESEARCH
SLEEP

Early Drug Development/Phase I

Our average patient completion rate is greater than 92%. We provide high quality and reliable data, as well as the lowest rates of early study discontinuations. This performance data is derived from complex studies such as dynabridging (CSF collection), bridging studies in schizophrenia and other CNS disorders, Definitive Cardiac QTc studies in the target patient population, and ethnic sensitivity or bridging studies in Japanese subjects. Traditional Phase I studies demonstrate more than 90% subject completion rates as well.

Illustrative performance data from recent EDD studies include:

1. Definitive QTc study in patients with schizophrenia using multiple active comparator medications. 98 patients were randomized within 5 months; 95 completed; Completion rate of 97%
2. Phase I bridging study to determine multiple ascending dose and maximum tolerated dose in schizophrenic subjects, maintained on study drug or placebo for 14 days. 52 patients were randomized within 4 months; 49 completed; Completion rate of 94%
3. Phase I dynabridging study using repeated serial CSF and plasma sampling to determine central and peripheral pharmacokinetics and pharmacodynamics for novel new drug class. 32 subjects were randomized within 3 months; 29 completed; Completion rate of 91%.
4. Phase I Japanese bridging study with matched Caucasian controls. 48 subjects were randomized within 4 months; 48 completed; Completion rate of 100%.

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Phase II-IV Clinical Research

Rapid regulatory and IRB approvals, quick enrollment, industry leading retention, and providing the agreed number of qualified subjects is proof of our commitment to quality. For the vast majority of these studies where enrollment is competitive, we obtain Sponsor approval to exceed the originally contracted number of research subjects. Psychiatric trials performed at all of our Southern California sites benefit from an integral system of dedicated staff and resources.

Our average performance, derived from more than 20 clinical studies performed in the past year for Phase II-IV psychiatric protocols, is 4.2 patients enrolled per month per study, with 2.6 patients being randomized or placed onto study medication.

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Sleep

Our two sleep sites are extremely successful in the highly competitive enrollment process. Sleep studies range from simple diary-based studies to those that require multiple sleep center nights using polysomnography. Moreover, research protocols can require large numbers of healthy subjects (transient insomnia) with very short enrollment periods or more specific sleep disorder populations with stringent inclusion criteria.

For transient insomnia in healthy normal volunteers we enroll an average of 49 subjects per month, with approximately 85% randomized to treatment. For elderly insomnia, where enrollment is more difficult, we average 11 patients in less than a month with a randomization rate of approximately 82%.

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