SleepMed Trial Expertise

SleepMed Clinical Research Services (CRS) is a recognized leader in support for sophisticated research into a wide range of sleep disorders.


Our research service experience includes Phase II – IV multi-center trials of therapeutics under development for the treatment of insomnia, narcolepsy, sleep apnea, circadian rhythm and restless legs syndrome.

We have provided centralized scoring services to multiple sponsors involved in the development of sleep therapeutics. We also have experience in managing international, multi-center trials incorporating over 40 sites. 

 

A Cutting-Edge IT Infrastructure

Managing PSG recordings from multiple sites utilizing today’s digital technology takes an experienced and focused IT team. We have developed and deployed the most robust IT infrastructure dedicated to the collection and processing of digital PSG recordings in the industry today.

At the sponsor’s request, data collected at investigator sites may be transmitted via secure internet communications to SleepMed’s data center. These data are transmitted, processed (scored) and archived in a secure, 21 CFR Part 11-compliant environment, using well-developed operating procedures. Powerful and flexible software applications, such as Morpheus, may be used to derive critical outcome parameters and generate reports for sponsors. 

 

A Proven Innovator 

SleepMed CRS has developed a leadership position in exploring automated scoring methods and advanced signal processing methodologies including fast fourier transform (FFT), power spectral analysis (PSA), cyclic alternating pattern (CAP) analysis, and adaptive segmentation.

We have been involved with multiple retrospective analysis projects that have assisted sponsors in assessing subtle changes in CNS data that may have been overlooked in the initial R&K scoring. We continue to be involved with special projects investigating the utilization of various advanced signal processing techniques to assist in early “Go-No-Go” decisions on new compounds. Additionally, the prospects for using the sleep period for data collection and advanced analysis for a range of compounds affecting CNS functions seem promising. 

 

Leaders in Pharma Trials

SleepMed CRS is a leading provider of centralized PSG data management services for clinical trials. We have managed centralized PSG data for many multi center trials, ranging from 1 to 135 sites.

We are a recognized as an expert PSG service provider and has contracted with many key pharmaceutical clients involved in the development of sleep therapeutics. 

SleepMed CRS has many years of experience with processing PSG data obtained in studies of insomnia, restless legs syndrome, obstructive and central sleep apnea, and shift work disorders. We have worked with PSG investigator sites worldwide to offer our clients expert assistance with protocol development, site selection, site training, site certification, centralized PSG reading and quality assurance.

If you are seeking a single source solution for expert centralized PSG data management along with multiple qualified investigator sites in a single IRB and pricing agreement, SleepMed can provide you with the answer. 

 

Testing of Diagnostic Devices

New devices to assist with diagnosing or treating sleep disorders are constantly being developed and tested before introduction into the marketplace. SleepMed CRS has significant experience with testing of these devices in many of our certified investigator sites across the country.

Please contact us to learn how our network of available sites and/or centralized reading/QA services may assist you with your project and help you move your product forward in a timely and cost-effective manner.

As more and more consumers understand how important their sleep is to their general well being, it is likely the demand for more and improved products will increase.

SleepMed has assisted several companies with testing sleep related products for the general consumer marketplace. Manufacturers can be sure that SleepMed will provide them with the most accurate assessments of how their products improve or monitor the sleep of their customers. 

 

Do you have questions?

We're here to help solve your sleep problems. Give us a call at 1 800 SleepMed 9a.m. – 9p.m. Monday – Friday.

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