Core Laboratories
Clinilabs Drug Development Corporation is a leading provider of core laboratory services for clinical trials, offering a high-performance platform that connects investigator sites and sponsors around the world to a validated and secure electronic data environment in the United States. Our core technology center hosts seven core laboratories that aggregate and centrally process data from multicenter clinical trials.
The value of our core laboratory is its ability to reduce statistical variance in clinical datasets. By processing data centrally, rather than having data scored or reported by individual investigator sites, we significantly reduce variation. This enables sponsors to more accurately determine the difference between treatment conditions in a clinical trial. In some cases, sponsors who have suffered a failed trial have successfully repeated the same study using our core laboratory processing.
Clinilabs’ core laboratories offer industry-leading operational expertise, physical and electronic security systems, and a high-performance network infrastructure to enable the centralized capture and processing of clinical trial data. The core laboratories provide clients with a turnkey solution, and offer investigator site qualification, device management, study-wide SOPs, centralized processing with rapid turnaround time, and a 24/7 helpdesk. Many of our staff members are bi-lingual, enabling us to communicate with sites in Europe, Eastern Europe, Asia, and Latin America in their native languages.
Clinilabs currently provides core laboratory services for the following types of data:
Clinilabs Drug Development Corporation is the world’s leading provider of centralized polysomnogram (PSG) and Home Sleep Testing (HST) data management services for clinical trials. We have managed centralized PSG data for more than 150 multicenter trials, and are recognized as the preferred provider of most major pharmaceutical companies involved in the development of sleep therapeutics. Clinilabs’ PSG core laboratory personnel are adept at processing PSG data obtained in studies of insomnia, restless legs syndrome, obstructive and central sleep apnea, narcolepsy, and circadian rhythm disorders. Services include the management of Multiple Sleep Latency (MSLT) and Maintenance of Wakefulness Test (MWT) data. We work with over 500 PSG investigator sites worldwide to offer our clients expert site selection, site training, site certification, and centralized PSG reading.
We deploy and support the latest electroencephalographic (EEG) recording equipment, train investigator site staff, and manage all aspects of EEG data collection worldwide. Our EEG readers are expert epileptologists who are capable of reading adult and pediatric EEG tracings. EEG studies may be combined with auditory or visual evoked potentials, computerized spike-and-wave detection technology, or other procedures. Seizure safety studies are our specialty. Clinilabs Drug Development Corporation’s relationship with the Epilepsy Study Consortium allows us to access to the world’s leaders in the field of epileptology.
Quantitative EEG (QEEG) studies are complex and require specialized knowledge and equipment to collect, analyze, and report data. Clinilabs offers expert QEEG services delivered by people who have worked extensively in the biomarker field. Our team provides evidence of pharmacodynamic effects on Theta, Delta, Alpha, Beta, and Gamma band activity in absolute and relative power.
Clinilabs Drug Development Corporation offers ECG core laboratory services that outmatch industry leaders, at lower cost. We stock and deploy the latest Mortara instrumentation, and utilize leading-edge technology, to capture and process ECG recordings at our core data center in the US. We provide traditional manual, semi-automated, and fully-automated ECG reading services.
Clinilabs Drug Development Corporation is proud to partner with Ambulatory Monitoring Inc (AMI) to bring the best actigraphy recorders in the industry to clinical trial settings. AMI’s Motionlogger devices set the standard in the industry, and are the most cited device in peer-reviewed actigraphy studies. Using standardized methods of data capture and processing, Clinilabs’ actigraphy core laboratory is able to provide high quality data that meet our clients’ needs. Actigraphy can be incorporated into a trial to assess sleep, wakefulness, activity levels, and circadian rhythms.
The Psychomotor Vigilance Test (PVT) is a sustained-attention, reaction-time task that measures the speed of response to a visual stimulus. The PVT is a surrogate measure of sleepiness. We deploy and manage PVT devices for use in multicenter clinical trials worldwide.
EMG and nerve conduction studies are used to evaluate muscle activity, muscle weakness, muscle wasting, and sensory symptoms in clinical trials. These assessments may be required in multicenter clinical trials for patients with movement disorders or conditions that affect the neuromuscular system. When this is the case, centralized EMG data processing provides a solution for standardized data acquisition across all sites. Our EMG core laboratory has the capability to collect and process EMG signals using standardized methods that result in data consistency and accuracy.
There is significant variability in subject ratings in CNS clinical trials. Clinilabs Drug Development Corporation’s centralized video services provides rater surveillance for psychiatry and neurology trials that maximizes rater reliability. By collecting videos of investigator ratings, and over scoring those ratings by a small group of experts, we minimize variance and enable sponsors to detect differences between treatment conditions in multicenter clinical trials.
The best way to predict the future is to invent it.
– Alan Kay