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Development of a Secure Document Management System for Clinical Trials
  1. case
  2. Development of a Secure Document Management System for Clinical Trials

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Development of a Secure Document Management System for Clinical Trials

effectivesoft.com
Medical
Healthcare

Challenges with Clinical Trial Documentation and Collaboration

Sentral Clinical Research Services faced challenges managing the increasing volume of documentation required for clinical trials. The process required seamless collaboration between numerous medical specialists located in research facilities and private practices, leading to inefficiencies in document exchange, version control, and approval workflows. Lack of mobility for participants accessing documents across different devices also contributed to challenges.

About the Client

A U.S.-based company specializing in medical research for new drugs and medical devices, facilitating physician and patient participation in clinical trials.

Project Goals

  • Develop a secure and centralized document management system for clinical trials.
  • Improve collaboration among medical specialists involved in clinical research.
  • Streamline document exchange (Word and PDF formats).
  • Ensure version control and approval workflows for all documents.
  • Provide mobile access to documents via PCs and iPads.
  • Enhance document organization and search capabilities.
  • Automate workflows for document review, approval, and signing.

System Functionality

  • Secure document repository
  • User identity and permission control
  • Document version control and history tracking
  • Automated approval workflows
  • Electronic signature functionality
  • Search functionality across projects and folders
  • Notifications for assignments and document updates
  • Comment and annotation features (QcNotes)
  • Mobile accessibility (PC and iPad)

Technology Stack

.NET
C#
AngularJS
MSSQL
WebDAVSharp
Microsoft Office Interop
iTextSharp
Spire PDF

Non-Functional Requirements

  • Scalability to accommodate growing data volumes
  • High performance and responsiveness
  • Robust security to protect sensitive clinical trial data
  • Reliability and availability

Expected Business Impact

The implementation of SentralBinders is expected to significantly improve the efficiency of clinical trials by streamlining document management, enhancing collaboration, and reducing the time required for document-related tasks. This will lead to faster drug development cycles, improved data integrity, and better patient outcomes. Improved version control and audit trails will also ensure compliance with regulatory requirements.

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