EDC that Powers
Clinical Trial Success
Electronic Data Capture System, which is trusted by clinical teams worldwide for decades.
Maintaining the highest standards for our clients
the EDC system you can trust
Trust your clinical trial data to a proven EDC system. Replior Trial Online EDC’s automated edit checks and real-time validation ensure the highest standards of data integrity and regulatory compliance. Our intuitive front-end builder accelerates trial setup and simplifies data collection. For over 20 years, clinical trial teams have relied on Trial Online EDC for accurate, trustworthy data to drive clinical trial success.
Replior Trial Online EDC
Replior Trial Online EDC offers a range of benefits that set us apart. Here’s why clinical trial teams trust Trial Online EDC.
Fast Trial Setup
Get up and running quickly with an intuitive front-end builder.
Protect Patient Data
Meet all regulatory requirements and preserve data integrity with our stringent data protection measures.
Improve Team Efficiency
Keep your team focused with our comprehensive dashboard featuring clear project overviews and actionable to-do lists.
Gain Actionable Insights
Make informed decisions with customizable reports tailored to your study's needs.
Maintain Accurate Data
Rely on automatic data saving and comprehensive audit trails.
Need assistance with your trial setup? Replior’s team of data experts can guide you through a complete configuration for quick study start-up.
Comprehensive Trial Management
Trial Online EDC easy-to-use trial builder allows clinical study teams to assign roles and configure trials without any coding.
Role-Based Access
Define permissions for various roles, including investigator, CRA/monitor, sponsor, trial/system administrator, assessor, coordinator, data manager, and medical coder.
Role-Specific Training
Deliver detailed, role-specific training modules before users access the system and maintain consolidated training records.
Effortless eCRF Creation
Design and manage eCRFs using a user-friendly construction module that requires no prior programming skills.
Simple Trial Configuration
Configure trials with features such as edit check validators, skip/add logic, derived calculations, and more.
Flexible Data Collection
Trial Online EDC supports all types of data requirements collected from patient visits and imported from other data sources.
ePRO Integration
Seamlessly integrate with Trial Online ePRO and third-party ePRO systems for precise patient-reported outcomes.
File Import and Export
Import lab files, images, videos, and other binary files. Export data to SAS, ASCII, Excel, and PDF formats.
Virtual Visit Integration
Collect data during site visits, between visits, and through remote Trial Online Virtual Visits with real-time video supervision.
Edit Checks and Queries
Automatically trigger edit checks and enable CRAs, data managers, and medical coders to create and forward queries.
Stringent Data Security and Compliance
Trial Online EDC maintains the highest standards of data security and regulatory compliance.
Regulatory Compliance
Meet global regulatory obligations, including FDA 21 CFR Part 11, GDPR, and HIPAA.
Data Security
Protect sensitive data with 256-bit HTTPS encryption and automatic logout after periods of inactivity.
Audit Trails
Ensure complete traceability from data entry through all changes, facilitating audit trail reviews with comprehensive reports and exports.
Related Products by Replior
Device Provisioning
Provide secure, preconfigured devices together with Trial Online ePRO.
Device Provisioning
Provide secure, preconfigured devices together with Trial Online ePRO.
FAQ
Is Trial Online EDC compliant with FDA 21 CFR Part 11, EMA, and other regulatory requirements?
Yes, Trial Online EDC is compliant with FDA 21 CFR Part 11, GDPR, and HIPAA, ensuring data security and regulatory compliance.
Can the EDC system be customized to meet specific study requirements?
Yes, Trial Online EDC allows easy configuration through an intuitive front-end trial builder, supporting complex studies with multiple treatment arms and randomization steps.
How does the system ensure data integrity and audit trails?
Trial Online EDC maintains a complete audit trail from data entry through all changes, supporting data integrity and audit trail reviews with comprehensive reports and exports.
What training and support does Replior provide?
We offer comprehensive training modules, continuous support, and a dedicated team to assist throughout your study journey.
What is the average time to implement and deploy Trial Online EDC?
Implementation time varies with trial complexity, but the initial setup and qualification process is performed within 10 days. Study configuration is typically ready for validation in 4 to 6 weeks.
Does Trial Online EDC integrate with other vendor systems?
Is Trial Online EDC compatible with other devices and operating systems?
Yes, our EDC supports all major web browsers and is fully responsive, working on desktops, laptops, tablets, and smartphones.
Does the system support multi-language capabilities for global studies?
Yes, study-specific configurations such as visits and eCRFs can be made in different languages to support global studies. The Trial Online EDC application interface is English only. Supported languages include:
Western and Northern European Languages:
- English (UK)
- Spanish
- German
- German (Austria)
- German (Switzerland)
- French
- French (Switzerland)
- Belgian French
- French (Italy)
- Portuguese
- Italian
- Dutch
- Flemish
- Swedish
- Danish
- Norwegian
- Finnish
North American Languages:
- English (US)
- Spanish (US)
Eastern and Central European Languages:
- Czech
- Hungarian
- Polish
- Romanian
- Russian
- Ukrainian
South and Southeast Asian Languages:
- Hindi
- Marathi
- Gujarati
- Bengali
- Telugu
- Tamil
- Kannada
- Malayalam
- Malay
- Chinese
Additional languages can be added upon request, making it suitable for global clinical trials so participants can interact in their preferred language.
How does the system handle data from wearable technology or remote monitoring devices?
While Trial Online EDC has APIs for data injection into CRF fields, Trial Online ePRO is better suited for handling data from wearable technology and remote monitoring devices.