How Venova Medical Automated Study Progress Tracking and Data Review for Its Device Study

Miracle is partnering with Venova Medical to support data oversight and clinical execution for a study evaluating the safety and effectiveness of the Velocity Percutaneous Arteriovenous Fistula (pAVF) System in patients with advanced chronic kidney disease (CKD) or end-stage renal disease (ESRD) who require dialysis access.

The study collects measurements across multiple visits and modalities, so close oversight of study status and workflows is critical. Because the data lived in separate systems, the team had to manually compile it, calculate metrics, track imaging review status, and maintain source data verification records.

Miracle worked with Venova to automate these workflows, giving the team a continuously updated view of subjects’ statuses, imaging review, and data quality across the study.

‍The Challenge: Turning Fragmented Study Data into an Actionable Picture

To understand both subject status and study execution, Venova’s team had to combine clinical, imaging, and operational data. Because that data was spread across multiple systems, key questions were hard to answer:

• Are the required images available and reviewed?
• Do dates and review statuses agree across systems?
• Which subjects and visits have completed SDV and data management review?
• Where are there outstanding queries or incomplete reviews?

Answering them required more than displaying EDC data. The data had to be reconciled, evaluated against protocol-defined logic, and translated into actionable study metrics.

Automating Subject Status Tracking. Venova previously calculated each subject’s protocol-defined clinical status by hand, using measurements from multiple visits and timepoints. Miracle automated both of the assessments involved.

Ultrasound-based status. The team had to review ultrasound measurements across follow-up visits, compare them over time, identify the earliest date each subject met the protocol criteria, and calculate the time from procedure to that date. Miracle now pulls the relevant measurements together and applies the protocol logic automatically, updating each subject’s status as new data arrives.

Dialysis-based status. This assessment required reviewing hemodialysis session outcomes over time and determining whether dialysis was delivered as required within a rolling assessment window. Applying these rules across sessions and subjects meant repeated manual calculations. Miracle automates the assessment and displays each subject’s status alongside key protocol-defined milestones.

At the study level, the team sees continuously updated counts and percentages of subjects meeting each tracked status, without the manual work previously needed to keep that view current.

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‍Reconciling Imaging Review Across Three Systems

Imaging information for the study spans three systems: the EDC, the image management portal, and internal review trackers. Keeping them aligned meant cross-checking records to see what had been uploaded, reviewed, or left outstanding.

Miracle brings these records into a single reconciliation view for each enrolled subject, across visit and event types. The view flags:

• Date mismatches between systems
• Missing image uploads
• Partial dates
• Missing or inconsistent review statuses

This lets Venova spot discrepancies and incomplete records quickly, focus follow-up where it’s needed, and move through imaging review faster.

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‍Replacing a Manual SDV and Data Review Tracker

Venova tracked SDV and data management review in spreadsheets, by subject, visit, and expected case report form. Keeping those spreadsheets in sync with the latest study data required constant manual updates, taking time away from actual data review and issue follow-up.

Miracle automated the tracker, calculating consolidated SDV and data management review statuses across all expected forms. A color-coded view distinguishes full from partial verification and review and highlights subjects and visits with open queries.

With the tracker updating itself, the data management team spends less time maintaining spreadsheets and more time resolving incomplete reviews and open queries.

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“For more than 15 years, I’ve relied on manually maintained spreadsheets for study operational oversight. With Miracle, the tracker updates automatically, and I can quickly see what’s done and what still needs attention. It saves me time and lets me focus on reviewing the data and following up on issues.”

— Eva Marszalek, MD, Director of Clinical Affairs, Venova Medical

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‍From Data Aggregation to Study-Specific Automation

Venova’s experience highlights an important distinction in clinical trial technology. Centralizing data is useful, but putting several systems on one screen doesn’t eliminate the work teams do with that data. The bigger opportunity is using connected data to automate the study-specific logic that sits on top of those systems.

Instead of assembling and reconciling information, Venova’s team can focus on reviewing results and acting on issues.

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‍Looking Ahead

As the study progresses, Miracle’s automated workflows will keep Venova’s view of study progress, imaging review, and data quality current as new data comes in. We’re excited to continue supporting Venova Medical as it advances the study and works to improve dialysis access for patients.

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‍About Miracle

Miracle is the control room for clinical trials. Our platform brings together data from clinical systems to automate reporting and give sponsors visibility into study progress, data quality, and operational issues.

For more information, visit miracleml.com or contact sales@miracleml.com.

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