Real Use Case – Prabandhan (Project Management System)
Managing clinical trials is a complex process involving multiple departments from registration to post-regulatory phases. Teams often rely on Excel, resulting in fragmented workflows and version issues. Manual data handling leads to errors, duplication, and inefficiencies. Real-time visibility and coordination are lacking across teams. Traditional methods no longer meet the demands of modern clinical operations in terms of accuracy, traceability, and efficiency.
Tracks changes and maintains historical records for accountability.
Helps meet legal and industry standards through controlled documentation.
Minimizes errors and standardizes processes.
Fosters seamless collaboration across teams with shared access to up-to-date documents.
Automates tasks, freeing up time for more critical work and reduces operational delays.
Centralizes documents for easy access and retrieval.
This project involves developing an application to facilitate collaboration and track study statuses for Clinical Research Organizations (CROs). The application will include the following key features:
A robust module enabling seamless onboarding and management of multiple stakeholders such as CROs (Clinical Research Organizations), Sponsor Divisions, and third-party vendors. It ensures quick registration, profile management, and centralized documentation for all vendors, streamlining collaboration across projects.
Comprehensive handling of the entire lifecycle of studies, including Bioavailability / Bioequivalence (BABE), Patient-based, and In-Vitro studies. The module covers every phase—study registration, execution, post-study record maintenance, and financial tracking—ensuring complete visibility and control throughout.
Detailed tracking of all user activities for enhanced security, accountability, and compliance. The module maintains a chronological log of every action, ensuring traceability for audits and adherence to regulatory standards (e.g., 21 CFR Part 11).
An advanced analytics engine that transforms raw study data into actionable insights. It facilitates decision-making, empowering stakeholders with real-time dashboards and customizable reports.
Built-in capabilities for cross-study comparison to optimize outcomes. This feature allows researchers to review historical data, identify patterns, leading to evidence-based enhancements.
An intuitive homepage offering quick summary statistics and key study metrics, enabling users to gain instant insights into ongoing activities, pending tasks, and overall study progress at a glance.
A smart notification system delivering timely alerts for crucial milestones, deadlines, and events.
A centralized system to manage user profiles and ensure secure access control, supporting authentication mechanisms for various stakeholder groups.
Role-based access control, allowing administrators to define specific permissions and responsibilities for different user types, ensuring data security and functional segregation.
