Services

eClinical Suite - CIMS

Brightech’s Clinical Information Management Suite (CIMS) is a comprehensive, fully validated, 21CFR11 compliant and fully customizable web-based clinical trial platform. This integrated proprietary system provides significant time and cost savings by sharing clinical trial information and data across all functional components during the course of the clinical trial process.

Brightech’s CIMS enables users to intelligently and intuitively manage the complexities of clinical trials by sharing consistent trial data across the entire trial process. This allows the sponsor to seamlessly manage trial processes, effectively deploy critical resources, proactively address performance issues and streamline operational workflows. It enables the sponsor to submit traceable, reliable and standardized data and allows regulatory agencies to easily and thoroughly audit study conduct and compliance. Brightech provides technical assistance, helpdesk and training to support your clinical program utilizing CIMS.

For more information, please visit the CIMS homepage.

Solutions

CIMS is an integrated system with the ability to utilize each module as a stand-alone clinical trial management application.

The key components of CIMS include:

• Clinical Trial Management System (CTMS)

Manage and support operational, reporting and administrative activities.

• Central Randomization System (CRS)

Subject randomization through web (IWRS), or text messaging (ITRV) or mobile (IMRS). Support static,

dynamic and adaptive randomization schemes.

• Clinical Supply Management System (CSS)

Comprehensive clinical supply and automated inventory management system.

• Clinical Data Management System (CDMS)

Comprehensive data management (DM) system to support site, DM and risk-based monitoring tasks.

• Document Management System (DOCS)

Storage, version control and routing of all study related files.

• Coding System (CS)

Manages and supports Medical Coding activities.

• Electronic Patient-Reported Outcome (ePRO) / eSource

Remotely capture patient reported data and source data via web or mobile.

• IRB Portal (IRB)

Platform for IRB to collaboratively and efficiently review and approve your clinical trials.

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