The OnlineCRF system is developed in full compliance with CFR21 Part 11, making it an ideal electronic data capture (EDC) solution for clinical trials conducted in the European Union and North America. Our platform is validated according to the principles of GAMP5 and GCDMP, ensuring that every project is individually configured to meet the specific requirements outlined in the clinical trial protocol. At Pharmaxi, we have established a comprehensive set of standard operating procedures—comprising 17 SOPs (SOP-DM-01 through SOP-DM-17)—that govern the configuration, validation, and verification of the system. Once these processes are completed, the Sponsor receives a complete documentation package confirming that all necessary procedures for the study have been successfully executed.
Access to the OnlineCRF system is secured by a robust authentication mechanism. Only users with a valid account can log in by completing an authentication form that requires a unique username and password. To maintain security, if a user remains inactive for 15 minutes, the system automatically prompts for re-authentication.
Our system is designed to support a variety of user roles, including project managers, remote monitors, on-site monitors, investigators, and observers. This role-based access control ensures that every user sees only the information relevant to their responsibilities, enhancing both security and data integrity.
OnlineCRF is capable of managing data collection across several countries. The platform allows for the segmentation of users and monitors by country, enabling independent data management tailored to each region’s regulatory and operational needs.
The visit and form configurator module enables you to set up any sequence of visits and create an unlimited number of electronic case report forms (eCRFs). This flexibility allows you to design data collection instruments that precisely match your study protocol and visit matrix. Additionally, you can specify the minimum and maximum allowable intervals between visits, ensuring adherence to study schedules.
Our system includes a dedicated module for randomization and stratification, configured according to the study protocol requirements. It supports both simple and block randomization techniques, and allows the definition of up to four stratification factors to ensure balanced and unbiased patient allocation.
OnlineCRF performs real-time pre-validation of data before it is saved to the database. Each field in the eCRF is configured with predefined acceptable ranges. If an investigator enters a value outside these limits, the data is not saved, and an alert is generated. This automatic “on-the-fly” validation significantly enhances data accuracy and reduces the need for subsequent data cleaning.
Data quality is further ensured through an eCRF verification process, whereby remote monitors or coordinators review the entered information. Once the data has been verified, a special flag can be applied to the eCRF, facilitating the evaluation of data completeness and quality.
The system features an integrated module for generating clarifying queries. If a monitor identifies discrepancies or needs additional information, they can generate a query that is forwarded to the investigator. The investigator can then either amend the data after cross-checking with the source documents or provide justification for the original entry.
After ensuring that an eCRF is accurately completed, only the Principal Investigator (PI) has the authority to sign the document using a digital signature. This step is crucial for final data approval and regulatory compliance.
Every modification made to the eCRF is recorded in a detailed audit trail. The system logs previous values, timestamps, and the reasons for any changes, ensuring full transparency and traceability throughout the data lifecycle.
The OnlineCRF system enables investigators to register adverse events and reactions directly. Upon data entry, an automatic email notification is sent to the person responsible for pharmacovigilance, ensuring prompt attention to safety issues.
For statistical analysis, the system supports exporting collected data in formats that are compatible with various analytical tools. This seamless integration simplifies downstream data processing and research analysis.
The interface of the OnlineCRF platform is fully configurable, with support for all major languages. This feature facilitates ease of use for global clinical trials and enhances communication across diverse user groups.
A dedicated study monitoring module aggregates and displays key metrics in real time. Users can access statistics related to site activity, including the number of enrolled patients, exclusions, and signed eCRFs. This module provides a comprehensive overview of study progress, aiding in efficient project management.
Every user login is logged with the exact date and time, and this information is accessible to the project manager. These logs are immutable, ensuring that no user can edit the authentication records, which bolsters the system’s overall security.
Additional modules and custom components can be integrated into the OnlineCRF system upon request. This ensures that our EDC solution can be tailored even further to meet the evolving needs of your clinical research.
If you have any questions regarding the features and capabilities of the OnlineCRF electronic data capture system, please call us at +48 739-108-217 or fill out our contact form. We also offer a free 30-minute consultation on any clinical research topics, helping you leverage our advanced EDC solution for successful, compliant clinical trials.
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