Digitizing clinical trial documentation for efficient TMF management and risk mitigation
Overview
Industry
Location
Biotech and Healthcare
USA
Technology Used
.NET React Azure functions
Azure DevOps
Azure Service Bus
Azure Storage
Cosmos DB
Docker
K8s
MySQL
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Project overview
The project began by focusing on Electronic Data Capture (EDC) to digitize large volumes of paper-based documentation, which included a rigorous process for cleaning and validating data. The scope then evolved to encompass Trial Master Files (TMFs) and risk management in clinical trials. The developed solution ultimately enabled the client to successfully transition to a Software-as-a-Service (SaaS) model.
Client background
A global pharmaceutical solutions organization that connects manufacturers, providers and patients to ensure access to necessary therapies. The company delivers comprehensive specialist services for all administrative aspects of clinical trial processes across the pharmaceutical, biotechnology, medical device and healthcare industries. They specialize in optimizing Trial Master File (TMF) management, reducing inspection risks and solving a variety of TMF-related challenges.
Goals
The project 's objective was to improve the accessibility and quality of medical data by digitizing all clinical trial documentation. This established a solid foundation for more efficient data analysis and the planning of subsequent trial phases. Additionally, the project supported the development of a platform for managing Trial Master Files (TMFs) in order to enable proactive risk management throughout the clinical trial process.
Results
Increased capacity
Raising our client’s processing power from one million documents per week to five million documents per day through automation.
Revenue opportunities
Supporting business growth by delivering 3,400% more processing potential by empowering our client to process 20+million documents per year.
Improved data accessibility and quality
By digitizing all medical documentation, we established a high-quality, accessible data foundation, which is now ready for in-depth analysis and future research planning.
Transition to SaaS model
Our client successfully transitioned from a service-based operation to a SaaS model, which strengthened their position as a market leader.
Enhanced regulatory compliance
By digitizing data management processes and focusing on TMF and risk management, our client can now offer a more robust and efficient solution for ensuring regulatory compliance.
Mitigated risk
The new platform helps our client avoid costly delays in clinical trials by ensuring all required documentation is complete and verified.
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