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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.
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:
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 and trained Bracket personnel, supporting unique needs of each clinical solution and study specific data management requirements
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 formatting to meet client T&L submission requirements
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 project managers and support staff to execute on a comprehensive project life cycle (PLC)
Solution-oriented PLC, integrating a proven project management methodology overseeing software development lifecycle systems development life cycle (SDLC) controls
Integrated validation framework, facilitated by Bracket’s Total Quality Management organization to manage systems development life cycle (SDLC) gates throughout the entire project lifecycle
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 end user support to meet the requirements of global clinical trials
Multilingual capabilities to support global end user requirements
Dedicated and trained Bracket personnel, supporting unique needs of each clinical solution and study-specific implementation
Regulatory-trained support personnel to ensure 21 CFR Part 11, HIPAA, and Safe Harbor Compliance throughout the support process