Data Monitoring

From query management to electronic signatures, every tool you need to maintain data quality, ensure compliance, and keep your study moving all within your EDC

Take the Complexity Out of Query Management

Manage all queries from one place within the EDC , streamlining communication across sites, monitors, and study teams, with no additional tools required.

Keep Your Data Clean and Reliable

Track data completeness, catch inconsistencies, missing values, and outliers early, and keep your database secure throughout the study with centralized monitoring.


Stay Audit-Ready at Every Stage

Get full traceability of every action and correction through the audit trail, so you can meet regulatory requirements and walk into any audit or inspection with confidence.

Monitoring Features That Work as Hard as You Do

From query management to electronic signatures, every tool you need to maintain data quality, ensure compliance, and keep your study moving all within your EDC
Consolidated view

A single centralized dashboard to monitor your entire study in real time, across all sites and patients.

Inconsistency detection

Automatically flag inconsistent or atypical data using the Data Cleaner and built-in statistics module.

 Query management
Locate and resolve missing or inconsistent data directly within the eCRF, no back-and-forth needed.


Tracking and audit trail

Every monitoring action is logged, ensuring full transparency and data integrity from first entry to database lock.

Real-time dashboards
Clear, actionable dashboards to track study progress and prioritize monitoring efforts at a glance.

Electronic signatures
Sign, verify, and lock patient forms with electronic signatures , ensuring data integrity, traceability, and compliance with FDA 21 CFR Part 11.

Customer success story

“We chose EasyMedStat because we needed software that could manage health data in full compliance with regulatory requirements.”

Rolland Hilsdebrant

QARA Manager 


EasyMedStat adapts to your needs

Choose only the modules you need. Combine them to build a powerful and scalable clinical data software.

Create your eCRF in minutes using a no-code interface. Our clinical EDC meets the highest standards for electronic data capture in clinical research and clinical trials.

eCRF
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patient visit inclusion survey
ePRO
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Gather patient-reported information with ease. Create and implement unique surveys that are completely integrated into your EDC and offer flexible ePRO scheduling.

Patient questionnaire screen asking how the patient is feeling today
Data monitoring
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Centralize data review and monitoring activities.
Open, assign, and resolve queries from a single dashboard to ensure high-quality, reliable clinical data.

EasyMedStat Query Lifecycle
Automated Statistical Analysis
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The only EDC with native statistical tools.
Analyze your data with an integrated sample size calculator, Student’s test calculator, chi-squared tests, and an intelligent data cleaner, no technical expertise required.

Frequently asked questions

  • Do I need advanced statistical knowledge to use EasyMedStat?

    Not at all. The platform offers guided workflows and automated analyses tailored to the most common needs in clinical research. You can run robust analyses without having to master complex statistical methods.

  • How does EasyMedStat handle data traceability?

    Every action taken on the platform is automatically logged: data edits, analyses, and exports alike. 

    Each event is timestamped and tied to an identified user, giving you a complete, reliable audit trail at all times. That trail covers the full history of every project, so you can track every data manipulation step with total transparency and walk into any audit or inspection fully prepared. And because the system is designed to meet the requirements of clinical research environments, you can count on full action history retention and data integrity throughout the entire project lifecycle.

  • Is EasyMedStat built to grow with my research?

    Yes and on every front. 

    The platform scales across project types, from straightforward studies to complex protocols, with modules that can be configured to fit your specific needs. EasyMedStat is regularly updated with new features and performance improvements to keep pace with evolving clinical research practices. And whether you're managing a small dataset or a large, multi-site database, the architecture is built to handle growing data volumes without any drop in performance.

  • GDPR Compliant Platform

    EasyMedStat meets all applicable standards and requirements for both interventional and observational clinical trials: ISO 14155, Good Clinical Practices (GCP), MDR / EU MDR, and GDPR data protection obligations. Data is hosted on an HDS-certified infrastructure, ensuring the highest level of security required by pharma and biotech companies. This built-in compliance reduces regulatory risk and simplifies audits and inspections.

  • How much does it cost?

    EasyMedStat is based on a flexible, modular pricing model designed to adapt to the needs and budgets of medical device manufacturers, whether startups, SMEs, or large groups. You only pay for the modules you actually need (eCRF, ePRO, monitoring, statistics, etc.), reducing costs compared to heavier solutions or full outsourcing. 

    The goal: a comprehensive, accessible solution tailored to the regulatory requirements for your clinical studies