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Corelab Data Services2024-02-16T13:39:18-05:00

Corelab Data Services

Clinilabs Drug Development Corporation is a leading provider of core laboratory data services for clinical trials. Our high-performance platform connecting investigator sites and sponsors around the world to a validated and secure electronic data environment in the United States. Clinilabs corelab data services center hosts seven core laboratories that aggregate and centrally process data from multicenter clinical trials.

Corelab Data Services Value

The value of our corelab data services 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 are able to significantly reduce variation. Furthermore, enabling sponsors to determine the differences between treatment conditions more accurately in a clinical trial. In some cases, sponsors who have suffered a failed trial have successfully repeated the same study using our corelab processing.

Industry-Leading Expertise

Clinilabs’ corelab data services offer industry-leading operational expertise, physical and electronic security systems, as well as a high-performance network infrastructure to enable the centralized capture and processing of clinical trial data. The corelab provides clients with a turnkey solution, offering investigator sites qualification, device management, study-wide SOPs, centralized processing with rapid turnaround times in addition to 24/7 helpdesk system.

Clinilabs provides the following data types:

As the world’s leading provider of centralized polysomnogram (PSG) and Home Sleep Testing (HST) data management, Clinilabs is the preferred provider of most major pharmaceutical companies who are developing sleep therapeutics. With more than 150 multicenter trials under our belts, our PSG corelab personnel are adept at processing PSG data obtained in studies of insomnia, restless leg syndrome, obstructive and central sleep apnea, as well as 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.

Seizure safety studies are our specialty and Clinilabs has a strong relationship with the Epilepsy Study Consortium which enables us to access the world’s leaders in the field of epileptology. Our trained investigator staff utilizes the latest electroencephalographic (EEG) recording equipment to manage all aspects of EEG data collection worldwide with expert epileptologists readers capable of interpreting adult and pediatric EEG tracings. Clinilabs may combine EEG studies with auditory or visual evoked potentials, computerized spike-and-wave detection technology, quantitative analysis (QEEG), or other procedures as needed.

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 corelab has the capability to collect and process EMG signals using standardized methods that result in data consistency and accuracy to evaluate muscle activity, muscle weakness, muscle wasting, and sensory symptoms in clinical trials. Multicenter clinical trials for patients with movement disorders or conditions that affect the neuromuscular system may require assessments through centralized EMG data processing.

Clinilabs 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.

Additionally, our Psychomotor Vigilance Test (PVT) capture a sustained-attention, reaction-time task that measures the speed of response to a visual stimulus which 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.  Clinilabs 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’ 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.

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