Electronic Data Capture (EDC) System
Trial Online EDC fulfils the needs of the most complex clinical trials. Robust, intuitive and secure EDC system accelerating trial set-up and clinical data collection.
Trial Online: More Than Just an EDC System
"Partnering with Replior has always been easy! Over the course of our studies, we have developed a friendly collaboration based on trust."
See our EDC in action.
Frequently asked questions
What are the core functionalities of Trial Online EDC?
Trial Online EDC is designed for the specific needs of complex clinical trials. It is a robust and secure while still intuitive system to accelerate trial setup and data collection. It allows clinical study teams to configure trials effortlessly through an intuitive front-end trial builder, including role-based access, edit check validators, skip/add logic, derived calculations, among other.
Is Trial Online EDC compliant with FDA 21 CFR Part 11, EMA, and other regulatory requirements?
Trial Online is a designed, developed, and tested computer system as defined in PIC/S ‘Good Practices for Computerised Systems in Regulated “GxP” Environments’. Trial Online is compliant with FDA 21 CFR Part 11, GDPR and HIPAA. Our Quality Management System is built on quality standards in the industry, e.g. guidelines and directives provided by ISPE, FDA, EMA and ICH.
Is Trial Online EDC compatible with other devices and operating systems?
Trial Online supports all major web browsers such as Google Chrome, Microsoft Edge, Firefox, Apple Safari etc. The system includes responsive web design and works well on tablets. The system can be used on smartphones, but we do not include that in our testing.
Can the EDC system be customized to meet specific study requirements?
Yes, Trial Online EDC allows effortless configuration of trials according to each specific need from start to finish. The eCRFs in our EDC are created in a construction module, that allows configuration of eCRFs fast and easily, so easily that no prior programming skills are required. Our current version of EDC is capable to manage up to 90-95 percent of all clinical trials, but there are other solutions better suited for the most complex studies requiring multiple treatment arms and randomization steps.
How does Replior ensure the security of sensitive data in Trial Online EDC?
We are fully committed to data security and therefore, we have incorporated multiple layers of protection:
- Strong authentication and 2-factor authentication: Trial Online EDC requires not only a username and password but also a uniquely generated code, offering an additional layer of security. We provide the flexibility to configure password complexity and security according to the specific needs of each trial.
- Dedicated hosting environment from redundant data centres: Our products, EDC included, operate from two geographically separated data centres, ensuring resilience and reliability. Each client or study benefits from a dedicated hosting environment, including exclusive servers, networks, and security protocols. This setup, involving network segmentation and dedicated servers, is crucial for maintaining a secure production environment.
- Encryption of data at rest and in transit: We ensure the safety of your data by encrypting all stored data. Furthermore, all communication with our products is safeguarded by TLS 1.2 and SHA 256 encryption, setting a robust standard for data transfer security.
- Multilayered backup strategy:
- Inter-data centre storage snapshots: Hourly storage snapshots are taken and retained for 24 hours, creating a continuous backup between our two data centres. Additionally, daily snapshots at 12:00 CET are stored for 30 days, providing a rapid recovery solution in case of data centre outages or disasters.
- Agent-based backup system: A daily backup is conducted using professional backup software, with all backup data securely stored at an alternate physical location for 30 days. This system itself is backed up daily, ensuring a comprehensive disaster recovery capability.
What training and support does Replior provide?
Trial Online EDC is designed with user-friendliness in mind, which means that if you have prior experience working as a Clinical Data Manager the process is self explanatory. Our CDM team is ready to assist you in all steps in the way, from co-building your first study to ongoing knowledge transfer and training. We offer ongoing support at any point in the study to ensure a smooth and efficient experience throughout the trial.
What is the average time for implementation and deployment of Trial Online EDC?
The implementation time varies on the complexity of the trial, but from the very beginning, a team is dedicated to your study specifically to ensuring a swift and efficient deployment process. The system setup and initial installation quallification process is performed within 10 days. If you would like the assistance from our Clinical Data Management team to configure the system according to your study protocol the lead-time varies with the study complexity and your review process. Usually a study configuration is ready for your final validation after four to six weeks.
What is the pricing and cost structure for Trial Online EDC?
Our pricing model is transparent and we offer flexible cost structures tailored to each trial needs. There are no current or down the road hidden fees, and we provide detailed pricing information during the consultation process.
Does Trial Online EDC integrate with other vendor’ systems?
Trial Online EDC supports integration with other clinical trial systems and third-party applications, facilitating data exchange and enhancing overall trial interoperability. Some examples are of our partners are S-Clinica, Suvouda and Veeva RTSM.
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