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Bracket eCOA℠ is the result of forging technological advances combined with an understanding of our clients’ most important objectives.

Outcomes are the product of human observation and state-of-the-art reporting, including the use of barcode scanning, mobile apps and seamless integration with other programs. Our program designs have put Bracket at the forefront of electronic Clinical Outcomes Assessments.

ePRO and eDiary

As a proud and active member of the Critical Path Institute’s (C-Path) ePRO Consortium, Bracket collaborates with industry leaders to advance the application and value of electronic modalities in clinical endpoint assessments.

ePRO Consortium

iOS & Android Platform

Bring Your Own Device (BYOD) mobile app solution

Easy to use interface with patient-friendly form features

Configurable feature set

Programmable and fully customizable alarms and alerts

Dynamic visit and form scheduling, reducing patient burden

Automatic data transmission upon questionnaire completion

Worldwide Wi-Fi and cellular data transmission mode

Barcode scanning capability for real-time tracking of patient dosing

Device procurement and fulfillment services worldwide

Seamless integration with Electronic Data Capture (EDC) Clinical Trial Management System (CTMS), and Interactive Response Technology (IRT) vendors

Support for off-the-shelf scales, surveys and questionnaires

Fully customizable compliance reports

The Rater Station

Bracket’s Rater Station℠ is a regulatory compliant device used in dozens of worldwide studies with extensive use in central nervous system clinical trials. With an intelligent and flexible design and availability in more than 60 languages, the Rater Station℠ is an advanced eClinRO tool that improves interview quality while reducing administration and scoring errors. Outcomes can be programmed to enforce a structured interview format and can be applied to a wide range of therapeutic areas and Clinician-Reported Outcomes, in addition to electronic Patient-Reported Outcomes and Observer-Reported Outcomes. Bracket Rater Station℠ is supported by a simple training process led by a team of expert consultants.

Bracket’s industry-leading Rater Station℠ solution provides clients unique advancements in eClinRO services, including:

 

Ease of data capture at study site

Elimination of transcription costs and errors

Prevention of missing and unreadable data

Instant availability of completed visit data

Built-in error trapping intelligence

Integrated scoring and audio and video capture

FDA-preferred means of capture

Real-time data and reports access

Customizable per protocol requirements

Collection of precise assessments across multi-site, global development programs

Identification of underperforming sites and raters

eObsRO

Bracket’s eCOA platform can be configured for use by parents, teachers, caregivers, and other non-clinical observers of a patients activities or symptoms.

Bracket’s eObsRO solution provides the following flexibility:

 

Multiple Deployment Methodologies

Multiple deployment methodologies to meet unique needs of Observer-Reported Outcomes. Our solution supports the use of telephone-based IVR reporting, web-based questionnaires, and mobile-device based applications.

Bring Your Own Device

Low cost solutions supported by Bracket’s Bring Your Own Device (BYOD) mobile app solution. Bracket’s mobile app is available on iOS and Android, so you can use what works best for you.

Support Large Dataset Analysis

Scalable reporting and data management capabilities to support large dataset analysis and industry-compliant data delivery methods.

The CDR System℠

Developed by Professor Keith Wesnes, the CDR System™ has become the industry standard for automated assessment of cognitive function in clinical trials for the last 20 years. Supported by an unparalleled publication record and the most comprehensive neuropsychopharmacology databases ever assembled, the CDR System℠ provides clients with the most sensitive set of tests ever developed to assess improvements and impairments in cognitive function.

The CDR System℠ assesses the major domains of cognitive function that are vulnerable to aging, fatigue, disease, pathology, trauma, diet and pharmaceuticals.

Used in more than 1,200 trials across 50 indications and available in over 30 languages, the CDR System℠ works in all clinical settings with any patient population throughout the drug development process.

The CDR System℠ provides the following benefits:

Core assessments can be completed in less than 20 minutes and can be administered by non-specialists with brief training

Data is automatically and securely recorded and uploaded directly into Bracket’s databases, readily available for review

Continuity both within and between research programs

Characterization of the cognitive effect of therapeutic substances

Measurement of change in function with high degree of sensitivity

Determination of the cognitive potential and effect of therapeutic substances

In addition to assessing the safety of new treatments, the CDR System℠ is widely used in the rapidly expanding field of identifying cognition enhancement

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