Northridge Launches 21 CFR Part 11 Compliant SharePoint Solution for Clinical Research Organization

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Built upon the Microsoft SharePoint platform, the custom enterprise application enables clinical adjudication management and supports compliance and reporting, resulting in streamlined business processes and improved efficiency.

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Northridge is pleased to announce its ongoing partnership with the one of the world’s largest academic clinical research organizations (CRO) to develop and deploy an enterprise application built on the Microsoft SharePoint platform with logging and event history that support compliance and customer reporting based on the FDA’s rigorous 21 CFR Part 11. The recently launched custom SharePoint-based solution enables clinical adjudication management and collaboration for the client’s clinical events classification (CEC) group.

The client engaged with Northridge to develop a solution that provides process and technology improvements for the CEC group. The CEC group performs clinical trial event adjudication – the assessment of clinical trial patient events or outcomes – as a key element in providing clinical trial endpoint data. Throughout a clinical trial, the client relies on integrated clinical event and data management processes to provide adjudicated endpoint data on a timely basis. The new SharePoint-based solution tracks and manages documentation, streamlines business processes, and helps with compliance and reporting.

The client chose the SharePoint platform for its workflow management, document management, auditing, reporting, and analytics capabilities. These foundational capabilities facilitate the management of critical clinical processes relating to medical imaging, clinical events classification, and trial master file management.

Northridge engaged with the client to establish a vision for extending SharePoint, examining how the SharePoint platform could and should be used to meet business needs. Northridge then assisted in developing a roadmap for deployment that involved training, governance, and custom development.

With the enterprise solution, Northridge and the client are pushing the limits of SharePoint, extending what it can do and how it can provide business and functional value across the organization. Building upon the base SharePoint platform, Northridge worked with the client to construct applications and processes specific to the business functions of the organization’s intranet, extranet, and internet. To manage the clinical business processes, the solution leverages both out-of-the-box and custom developed SharePoint components.

The recently launched SharePoint solution is proving to be transformational, both internally and externally. The client has demonstrated market differentiation in the clinical trial management industry. The clinical events classification application is the first automated system of its kind and offers capabilities not yet seen in the market. As a result of the application integrations, the client is now able to offer customers an electronically based compliance solution with logging and event history that support compliance and customer reporting based on the FDA’s rigorous 21 CFR Part 11. With business critical processes captured, automated, and standardized, the client’s CEC group also benefits from increased efficiency, a reduction in errors, and lower costs associated with paper, printing, and shipping.

About Northridge
Northridge is a nationally-recognized leader in delivering collaboration solutions to mid-market and enterprise clients throughout North America. By combining vast expertise in the areas of business consulting, user experience, and collaboration technology, Northridge delivers comprehensive collaboration solutions for the Enterprise and Internet that are both highly functional and beautifully creative.

With a focus on delivering a measurable return on investment for each client, Northridge offers a rich portfolio of services including collaboration strategy, portal migration and implementation, dashboards and analytics, user experience and branding, collaborative websites, and custom collaboration solutions. For more information, please visit http://www.northridge.com or call (855) 587-9900.

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Taylor Rhyne
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