eCRF and RTSM

Chronicles eCRF and RTSM is an electronic data capture (EDC) system designed for clinical data collection in drug development and medical device research. The platform is built for research and development teams conducting interventional and non-interventional clinical trials, and covers the full study lifecycle from case report form design through data collection, randomization, and reporting.

The system was developed by clinical research experts with experience in organizing, conducting, and processing clinical trial data. Chronicles eCRF is built to meet ICH requirements across all stages of the software lifecycle, and is designed to reduce time and cost associated with study setup, monitoring, and statistical analysis preparation. The platform supports data integrity and validation standards aligned with modern international requirements.

eCRF Features

• Built-in forms and visits designer for rapid study configuration
• Normal ranges module for data validation
• Integrated MedDRA and ATX dictionaries
• Customizable role-based access model
• Support for one-sided and double-blind study designs
• Randomization with stratification
• Predefined reports and data listings
• Suitable for both interventional and non-interventional studies
• Applicable to clinical investigations of medical devices

Randomization and Trial Supply Management (RTSM/IWRS)

• Stratification by any defined criteria
• Unblinding procedures in accordance with the E2B guide
• Integrated supply management
• Flexible dispensing rules
• Available as a standalone product or integrated directly within the eCRF

Data Security and Infrastructure

• Data centers certified to ISO 27001
• TIER III infrastructure
• GDPR compliant
• 99.5% system availability
• Regular data backups

Professional Consulting and Implementation Support

• Automation services for quality management systems, including SOP development and staff training
• Systems integration and business process adaptation
• Personnel with GxP expertise and experience in research organization audits and software development
• Full documentation package, training, and ongoing technical support included with system purchase

Chronicles eCRF and RTSM is delivered as a cloud-hosted solution using ISO 27001-certified data centers with TIER III infrastructure. The vendor follows an agile development methodology and incorporates client feedback throughout the product lifecycle. The broader Chronicles platform also includes modules for eTMF, eDMS, CTMS, and logistics, making it applicable across multiple functions within clinical research organizations.