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Bracket eCOA Services are available to all of our clients for any level of support and management and for all their electronic Clinical Outcomes Assessments needs.

Bracket’s eCOA℠ services include Scale Management for tailor-made scale and rating instruments and use, Data Management for supporting data reconciliation and delivery, Project Management for support and guidance from project kickoff to implementation, and End User Support to ensure continuing and effective service.

Scale Management

Bracket eCOA Services take the guesswork out of selecting, acquiring, translating and fulfilling clinician-rated and patient-rated scales for clinical trials with Bracket’s Scale Management solutions.

Clients receive carefully reviewed scales and support every step of the way from our expert clinicians. This attention to detail – from scale-version adaptation to translations that account for subtle cultural nuances – provides sites with the best possible scales for each study. With more than a decade of experience in hundreds of rating instruments, relationships with world-renowned scale authors and a robust in-house database of scales and questionnaires, it is assured that scales are tailor-made to collect pertinent information.

Finding the proper scale and rating instrument is a meticulous process, one that calls for more consideration than a simple keyword search. Inaccurate scales, incorrect scale versions, translational oversight and source document inconsistencies can all derail clinical trial outcomes and financials.

Comprehensive Scale Management services can combat these potential issues by offering the following:

Identify appropriate scale versions and translations

Locate copyright holders, licensed distributors and associated costs

Determine commercially available scale translations

Provide permissions and licensing

Obtain copyright holder permissions

Receive source copy of scale in English

Compare source copy of scale to sponsor (e)CRF

Prepare scales for translation

Perform translation and harmonization

Complete scale translations and provide Certificate of Translation

Perform fulfillment

Acquire and distribute manuals and scoring sheets to sites

Organize documents by visit, rater or subject on our validated website

Data Management

Bracket's data management services are comprehensive; supporting high volume data reconciliation and delivery services.

Our scalable infrastructure, systems and support personnel ensure high quality and accurate data is delivered to our clients to meet regulatory filing requirements by providing:

Dedicated & Trained Personnel

Dedicated and trained Bracket personnel, supporting unique needs of each clinical solution and study specific data management requirements

SAS Data Extract & Delivery Management

Deep experience in SAS data extract and delivery management to meet all statistical analysis requirements throughout the life of the clinical trial

CDISC-compliant ODM and SDTM

CDISC-compliant ODM and SDTM formatting to meet client T&L submission requirements

Project Management

Bracket’s senior leadership team offers both technical and project management services.

Our experienced team approach is designed to optimize our ability to best serve clients. Bracket’s goal is to continue building a highly-scalable resource model while leveraging each team’s expertise, allowing us to better serve our clients. We provide a dedicated cross-functional team from the time of project kickoff through solution implementation. Our ongoing support includes:

Experienced Managers & Staff

Experienced project managers and support staff to execute on a comprehensive project life cycle (PLC)

Solution-Oriented PLC

Solution-oriented PLC, integrating a proven project management methodology overseeing software development lifecycle systems development life cycle (SDLC) controls

Integrated Validation Framework

Integrated validation framework, facilitated by Bracket’s Total Quality Management organization to manage systems development life cycle (SDLC) gates throughout the entire project lifecycle

End User Support

Bracket’s End User Support is a seamless experience which supports our clients’ clinical needs.

Bracket provides direct support across our entire portfolio of solutions, providing a seamless end user experience unique to the technology and service implemented in support of our clients’ clinical needs.

24x7x365

24x7x365 end user support to meet the requirements of global clinical trials

Global Support

Multilingual capabilities to support global end user requirements

Trained Bracket Personnel

Dedicated and trained Bracket personnel, supporting unique needs of each clinical solution and study-specific implementation

Regulatory-trained Support

Regulatory-trained support personnel to ensure 21 CFR Part 11, HIPAA, and Safe Harbor Compliance throughout the support process

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