Ultragenic implements the Webform module of its UltraINGEST suite to standardize and automate the data ingest process for a leading US based BioPharma company.
The Challenge
A US based BioPharma company required an efficient and automated method to report data for adverse events, product complaints, and clinical queries, going beyond the traditional paper-based form. The digital form alternative developed by their team presented several limitations impacting the overall efficiency, accuracy, and scalability of the system.
The key challenges were:
• The manual paper-based form system is an error-prone process that led to inefficiencies, delays in processing, and difficulties in tracking and managing reports.
• The digital form system had limitations with respect to integration with other systems, long development cycles, heavy processing and implementation costs, scalability, repeated testing and validation needs, and customization.
• In addition to data being received from diverse sources and in varied formats, it was also received for different purposes – from adverse event reporting to product quality complaints. They also needed multiple distribution rules.
• The client wanted a single solution, which would be robust, stable, time and cost efficient, secure, scalable, and future-ready using modern technology and automation.
Key Deliverables
• Built-in automation to eliminate the inefficiencies of a manual system
• Reduced development and validation cycle in configuring custom forms as needed
• Capacity and capabilities in the system to ensure long term stability, scalability, and security
• System intelligence to streamline data processing based on its purpose and destination
The Ultragenic Approach (Solution)
Based on the client’s challenges and our understanding of the key deliverables, we implemented our webform module of the UltraINGEST suite.
• The Webform module has pre-validated fields which can be added to configure custom forms, without the need to write additional code.
• The solution streamlines the data ingest process with its integration capabilities across multiple systems (email, ftp, safety system).
• The solution incorporates out-of-the-box intelligence to determine the type of form and purpose of the data, channeling it to the intended destination.
• It has efficient reconciliation capability, ensuring accurate distribution and tracking of information to support the multi-system framework and regulatory compliance efforts.
• The in-built compliance functionality in the solution provides regular reminders to ensure the information stored in the ingest system is processed timely and does not miss any compliance protocols.
• GDPR compliant safety protocols have been provided in the solution to ensure complete data safety and privacy through encryption, single sign-on (SSO) and other intelligent safeguards.
Key Takeaways
The Webform module has delivered significant productivity, process, and data protection gains, that include:
• Upto 90% time saving on configuration of new and amendments to existing forms
• Quick turnaround in configuring custom forms by client team through out-of-the box validated forms functionality
• Significant cost saving through low implementation costs and no maintenance overheads
• Greater process efficiency and accuracy through in-built automation and eliminating human-error specifically for distribution and reconciliation
• Unified workflows and monitoring
• Non-compliance reports
• Centralized Tracking
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