Client Background
Driving Efficiency in Clinical Trials
A global clinical research organization managing multiple therapeutic trials relied on diverse Electronic Data Capture (EDC) systems, each with unique data structures and access protocols. Manual processes such as logging into multiple systems, exporting and reconciling patient data, preparing CRF updates, and storing reports consumed significant time and resources. This approach created inconsistencies in data quality, delayed reconciliation cycles, and posed risks to compliance, ultimately increasing costs and operational burden.
Challenge
Difficulty in Managing Manual Data Workflows
Clinical operations teams faced inefficiencies from fragmented manual workflows—logging into multiple EDC systems, reconciling data manually, and reviewing discrepancies through time-intensive checks. CRF updates caused further delays, while reports lacked standardized audit trails. This led to heavy workloads, delayed reconciliation cycles, inconsistent data quality, higher monitoring costs, and elevated regulatory risks, ultimately slowing trial execution and undermining compliance readiness.
Healthark’s role
Automating Data Operations with Power Platform
Healthark designed and deployed the EDC Connector, a cloud-enabled, low-code solution leveraging Microsoft Power Apps, Power Automate, and Azure services to streamline trial operations.
- Configurable API Integration Unified access to multiple EDC APIs with secure credential management through Azure Key Vault.
- Automated Data Reconciliation Power Automate flows compared mapped fields, flagged discrepancies, and generated Excel-based reports with notifications.
- Controlled Patient Data Updates A two-bot process validated and executed updates with rollback and real-time alerts.
- Audit-Ready Data Extraction Automated workflows generated standardized PDF reports with metadata and secure Azure storage for compliance.
Empowering Tomorrow's Healthcare
This case study highlights how process automation with Power Platform transformed clinical trial operations from manual, reactive tasks into proactive, scalable, and compliance-ready workflows. By embedding audit readiness, error handling, and user empowerment into the design, the EDC Connector set a new benchmark for automation in regulated healthcare. This solution demonstrates how healthcare organizations can reduce costs, improve accuracy, and accelerate trial execution – paving the way for more efficient and patient-centric innovation.
