Our staff includes experienced principal investigators, dedicated cardiologists, psychiatrists, experienced ECG technicians/nurses and pharmacologists.

We were recently the worldwide high enroller for several antipsychotic cardiac safety studies conducted in patients with schizophrenia (Pfizer, Abbott Laboratories, HMR-Aventis) and in a recent antidepressant trial (Eli Lilly and Company). We can enroll, depending on timeline and study logistics between 30-100 patients, within a five-month time frame, and most importantly, with completion rates exceeding 90%.

Our clinical scientists have extensive experience in protocol design and provide practical assistance on inclusion and exclusion criteria, dosing, and other considerations to achieve the correct balance between practicality and regulatory rigor.

Our technicians are certified from multiple sponsors/ECG labs and are trained to minimize variance during data collection.

CCT provides the highest quality data along with industry-leading enrollment. Our 35-bed inpatient unit is equipped with standard 12-lead ECG machines, 12-lead Holter (Mortara) monitoring, telemetry, echocardiogram and 24-hour per day nursing surveillance. We work with leading central ECG laboratories and are intimately familiar with various equipment and data handling logistics.

In recent years, a drug's cardiovascular effects at supra-therapeutic exposure levels have become an essential component of the NDA submitted to the FDA. In particular, the risk for QTc prolongation has received particular attention due to its relationship to Torsade de Pointes. At CCT, these studies can be conducted in both healthy volunteers and in patients with Schizophrenia, Depression, Anxiety and Sleep disorders, and Alzheimer's Disease.

Historically, QTc data was obtained and pooled as part of the clinical trials. However, current regulatory guidance from the FDA and ICH now requires well-designed, prospective studies with sufficient power to detect whether a drug prolongs QTc intervals, usually incorporating an active control designCCT is a leader in the conduct of QTc Definitive Studies and one of the few Phase I Early Drug Development sites that routinely performs thorough Cardiac Safety evaluations in the target population during a Maximum Tolerated Dose Finding study.

Click here to contact someone for more information on starting your QTc study.