Frequently Asked Questions
Indeed. Trial Online EDC allows easy configuration of trials according to each specific need from start to finish. The eCRFs in our EDC are created in a construction module, which allows for speedy and easy configuration, so easy that no prior programming skills are required. Our current version of EDC is capable to manage up to 90-95%of all clinical trials, but when it comes to most complex studies requiring multiple treatment arms and randomization steps, there are other solutions better suited, and we will gladly help you find yours.
- 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.
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 qualification 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 on the study complexity and your specific review process. Usually, a study configuration is ready for your final validation after 4 to 6 weeks.
The ePRO native app for Android and IOS is designed to suit all age groups and we have received 94% compliance and 93% patient retention in a study with participants of 69 years old average.
Trial Online ePRO employs gamification to engage patients, with features such as customizable awards, reminders and notifications, and progress tracking. The ePRO app can be used on patient’s own device (BYOD) but also on a device provisioned by Replior, whenever required.
The ePRO app includes a tailored functionality through which it communicates directly with the external device and sends continuous data in real-time to the database. The relevant data can be visualized in the ePRO app by the patient through specific study widgets.
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Yes. We are most excited when we receive requests. We exercise client-driven innovation for universal system enhancements. We are happy to discuss your special requirement and use our agile approach to provide a solution. We have multiple examples where a client-feature request has been developed and added to our systems in a general, configurable manner, available for all clients. This means that we share the special development cost with you when adding new special features.
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