Cloud-based Clinical Trial Management Software

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 Our software platform is fully validated under FDA regulation 21 CFR Part 11, ensuring compliance with rigorous standards for electronic records and electronic signatures.  This validation is critical for maintaining data integrity, traceability, and security—key requirements for FDA audits and regulatory submissions in clinical research.  

 Each user in the our software platform can only view or modify information appropriate to their role, such as investigator, monitor, or data manager.  This approach enhances data security, supports regulatory compliance, and minimizes the risk of unauthorized access or accidental data changes—critical factors in maintaining the integrity of clinical trials.  

 Our Electronic Data Capture (EDC) technology allows clinical trial data to be collected and stored digitally, replacing traditional paper-based methods.  EDC is essential for improving data accuracy, streamlining workflows, and enabling real-time access to trial information—critical for faster decision-making and regulatory compliance.  

 Electronic Patient-Reported Outcomes (ePRO) allow participants to conveniently submit health data using mobile devices, making it easier to capture timely and accurate participant input from anywhere.  Mobile-enabled ePRO improves participant engagement, reduces delays in data collection, and supports compliance with regulatory standards by ensuring consistent, real-time reporting throughout the trial. 

The Medical Internet of Things (mIOT) refers to connected medical devices, such as wearables and products under investigation that collect and transmit real-time health data from trial participants.  Integrating mIOT into our software platform enhances participant monitoring, enables earlier detection of adverse events, and supports decentralized trials by allowing data collection from participants in their own homes. 

 Our Logistics module streamlines the tracking of investigational products and related hardware, providing real-time inventory visibility and full traceability across clinical sites.   By automating packing slip creation and shipment tracking, it ensures accurate delivery, reduces manual errors, and supports compliance with regulatory standards for clinical trial materials.  

 Our reporting functionality provides real-time insights into trial progress, participant data, and operational metrics, enabling faster, data-driven decision-making.  Robust reporting is essential for maintaining transparency, meeting regulatory requirements, and ensuring stakeholders have access to accurate, up-to-date information throughout the trial lifecycle.