eCRF

EasyMedStat's e-CRF (Electronic Case Report Form) is an electronic data capture (EDC) tool designed for clinical studies. It is intended for medical device manufacturers, hospital-based researchers, and academic investigators who need to collect, store, and manage patient data in a structured, compliant, and collaborative environment. The platform is built to reduce friction in data collection and lower monitoring overhead.

The tool allows users to build patient forms directly within the application without requiring advanced technical skills or programming knowledge. Forms can be constructed by creating variables, visits, and categories, or by importing an existing Excel file, which automatically generates an eCRF from previously collected data.

Core Features

• Form builder that supports creating variables, visits, and categories directly within the application, with no complex training required.
• Excel import functionality that converts existing spreadsheet data into a structured eCRF automatically.
• Automatic data saving during form completion, preserving entries even during poor internet connectivity.
• Support for adding images to patient forms to provide additional context.
• Granular permission controls for sharing studies with other researchers or research assistants, allowing defined access levels per participant.
• Built-in data validation checks to detect errors and inconsistencies at the point of entry, reducing human error.

Monitoring and Compliance Tools

• Audit trail that records all modifications, additions, and deletions made by users, supporting full data traceability.
• Inclusion reports and completion progress tracking to monitor study status in real time.
• Query management tools for identifying and resolving data issues.
• Electronic signature support.
• Monitoring report generation to support regulatory compliance requirements.
• Data storage on HDS (Health Data Host) certified servers, ensuring secure storage in accordance with applicable regulations.
• Support for ISO 14155 compliance for medical device manufacturers conducting clinical investigations.
• Facilitation of post-market clinical follow-up (PMCF) studies and similar post-market surveillance activities.

Benefits for Medical Device Manufacturers

• Structured data collection and traceability features that support compliance with regulatory standards such as ISO 14155.
• Simplified data collection and analysis for post-market studies (PMCF/SCAC), enabling continuous product monitoring.
• User-friendly interface designed to improve physician adherence and reduce data entry errors.
• Native integration of statistical analysis within the platform, allowing investigators to derive value from their data collection work directly.

Benefits for Hospitals and Academic Researchers

• Accessible implementation that does not require advanced programming skills, enabling quick study start-up.
• Import of existing data from Excel files or databases to avoid manual re-entry and associated errors.
• Real-time data collection enabling researchers to track study progress, identify trends, and make timely decisions.
• Support for decentralized studies by enabling remote data collection, reducing the need for on-site monitoring and lowering travel-related costs.
• Full audit trail and data change management to meet regulatory traceability requirements throughout the research process.

Training Options

1. Online self-training module available through the EasyMedStat Academy, including explanatory videos, tutorials, and practical examples. Users can complete training at their own pace, and a certificate is issued upon completion.
2. Live video training sessions facilitated by EasyMedStat experts, covering eCRF creation in approximately two hours. These sessions are interactive and allow participants to ask questions and receive live assistance.

Integration and Support Services

• A dedicated integration service is available for users who prefer not to configure their eCRF independently. EasyMedStat's team works directly with users to design and set up the eCRF according to their specific study requirements.

EasyMedStat's e-CRF is a cloud-based platform with data hosted on HDS-certified servers. It is suitable for both regulated clinical investigations and academic research studies, and includes native statistical analysis capabilities alongside its data capture functionality.