Signal Enhancement System (SES)

Signal Enhancement System (SES)The Signal Enhancement System (SES) - Quality Control Technology for CNS Clinical Trials

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The Technology


The Cognition Group's (TCG) innovative technology, the Signal Enhancement System (SES) promises the utmost in rater drift minimization and consistency of ratings in CNS clinical trials. SES is part of a cost-effective and technologically advanced system that allows for greater control of the clinical interview at the site. The system not only ensures that interviews are conducted according to protocol with consistently applied interview techniques, but also facilitates expert and consensus ratings, controls for raters' enrolment bias and expectancy bias, and ensures that correctly diagnosed patients are entered into the study.

Our proprietary technology addresses in-study rater variance enhancing data quality. The technology's strength is based on focused investigator performance, controlled interview techniques, and reliable assessments.

The technology records the patient interview at the site through audiovisual capture. A laptop with a 180 degree motion-detecting camera and high-quality USB microphone is distributed to sites for recording their interview session and collecting collateral information. The recorded interview is stored in a secure server for rating and observation by an independent or expert rater.

The Methodology

SES's process differs from centralized rating systems in that it preserves the interaction between the site rater and the patient. The system also facilitates the assessment of new raters joining the study.

The complex system supports a range of methodologies, including consensus ratings. One methodology used in a particular study was developed in conjunction with a pharmaceutical partner and involves an active collaboration between the site rater and an independent expert rater.

TCG's clinical trial experts along with your team will discuss and implement the most appropriate method for use in your study.

Informed Consent – Secure, Reliable, and Efficient

Informed consent has always been a difficult hurdle in CNS clinical trials. Careful examination, documentation, and review are required to ensure that the subject qualifies for, is aware of, and consents to participation in the study. This process can be particularly difficult for cognitively impaired subjects and those with significant problems in functional literacy.

TCG's simple but effective solution to the complications of informed consent is now a key feature of SES by integrating a video recording of the subject's assent, we immediately see many benefits such as:


Helpdesk

Main Office:

  • Toll-free: (888) 454-1265
  • Local: +1-302-454-1265

Helpdesk:

  • USA: 888-889-1157
  • Local: +91-124-416-6107
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Testimonials

"Working with The Cognition Group was a very profitable experience, combining both great professionalism and a pleasant team to work with."

Pierre-François Pénélaud
Project Director, Servier