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:

Polysomnography (PSG)

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.

Electroencephalography (EEG)

Unlock the power of encephalography (EEG) with our premier EEG analytic services

Clinilabs uses the latest EEG hardware and software to capture and analyze data from single center and multicenter clinical trials. We pioneered standardization in EEG processing more than 20 years ago, and have provided trusted data to our customers ever since. Our team includes experienced neuroscientists, data analysts, and engineers qualified to deliver insight-ready output in an efficient and compliant manner. While standardization is the foundation of everything we do, we understand that each project is unique. We offer customized solutions to meet the needs of each project and each specialty population under study.

Let Clinilabs support your next EEG project!

Data Acquisition

Investigator site selection
Instrumentation options that meet current industry standards
Comprehensive data collection manuals, tailored to clinical trial protocols
Conventional and high-resolution EEG recording methodologies
In-laboratory and wearable set-up options

Data Processing

Processing by highly skilled technicians and board certified epileptologists for seizure detection
Artifact removal, signal filtering and normalization
Data segmentation

Advanced Signal Analysis

Time-frequency analysis
Source localization
Predictive modeling

Report Generation

Detailed visual and statistical reports
Customized insights based on your research goals
Interactive data visualization tools

Quantitative electroencephalography (qEEG)

Clinilabs’ qEEG services provide powerful tools for use in clinical trials, offering insight into brain function and the impact of therapeutic interventions. Our expert team delivers sophisticated analyses of brain electrical activity through power spectral analysis and quantification of relevant qEEG bandwidths. Customers receive objective, quantifiable data on brain function that represent unparalleled value as biomarkers of brain and drug activity.

Applications for qEEG Biomarkers

Baseline measurement and longitudinal monitoring
Exploration of kinetic-dynamic relationships
Prediction of drug response
Safety monitoring

Electrocardiography (ECG)

Clinilabs’ core laboratory enables sponsors to collect and process electrocardiograms (ECGs) using state-of-the-art instrumentation and time-tested standardized methods, resulting in datasets that can be used to assess cardiac safety with confidence.

Many CNS drugs can produce impairments in cardiac conduction. Some of these impairments, such as prolongation of the Q-T interval, can lead to serious adverse events such as fainting, cardiac arrest, and sudden cardiac death. Approximately 19% of recent drug studies reviewed by FDA demonstrated QT prolongation, and 30% (almost 1/3) of submissions showing QT prolongation are in the CNS therapeutic area. It is clear that cardiac safety assessment is essential for the development of neurotherapeutics.

Clinilabs provides exceptional support for routine safety ECGs, intensive Holter monitoring, and thorough QT studies. ECG data are transmitted to our core laboratory using the latest data transfer technology, placing your source data in one centralized location for processing and analysis. Our data centers, strategically placed in North America and the Asia Pacific region, offer maximum coverage worldwide. Most importantly, our ECG team emphasizes customer service, with expert ECG reads, rapid turnaround times, specialty support for investigator sites, and easy access to helpdesk staff.

Rely on Clinilabs when accurate assessment of cardiac safety is required.

Actigraphy and Psychomotor Vigilance Testing (PVT)

Clinilabs is proud to partner with leading device manufacturers to combine the best in wearable actigraph technology with expert core laboratory data management. We have set the standard in the industry, using validated devices and workflows that integrate actigraphy output into large clinical datasets. Actigraphy can be incorporated during subject screening or following treatment to assess sleep, wakefulness, activity levels, and circadian rhythms for extended periods, adding valuable endpoints to a clinical trial design.

Some of the wearable devices we employ are capable of measuring parameters beyond activity, such as skin surface temperature, respiration, or environmental light. Electronic patient reported outcomes (ePRO) may be built into our devices, with the option to perform ecological momentary assessment (eEMA). Vigilance assessment may be performed directly on a wearable device that presents the Psychomotor Vigilance Test (PVT) to the subject at specified timepoints. The PVT is a sustained-attention, reaction-time task that measures the speed of response to a visual stimulus. It is a well-known surrogate measure of sleepiness. We deploy and manage PVT devices for use in multicenter clinical trials worldwide.

Wearable device application areas include: sleep disorders, circadian rhythm disorders (e.g., shift work disorder, jet lag), movement disorders, fatigue, Alzheimer’s disease agitation, attention deficit hyperactivity disorder, depression and treatment resistant depression, and pain.

Electromyography (EMG)

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.

Video Ratings

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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