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

In the clinical trials industry, the EDC system plays a crucial role. Choosing the right EDC system is not just about improving operational efficiency—it's about streamlining the entire research process, from initial planning to execution and reporting. With the increasing demand for seamless EDC and electronic Patient-Reported Outcome (ePRO) integration, it's crucial to select systems with proven interoperability.

Trial Online EDC empowers clinical study teams to effortlessly configure their trials from start to finish, all through an intuitive front-end trial builder.

Every configuration includes:

Role-based access

Edit check validators

Skip/add logic

Derived calculations

And more

Trusted by

"Partnering with Replior has always been easy! Over the course of our studies, we have developed a friendly collaboration based on trust."
Cécile Paquet Luzy
MSc Head of Clinical Science
Azafaros

Trusted by

See our EDC in action.

Features

Platform Agnostic

Trial Online EDC System has fully responsive design and works perfect on a desktop computer, laptop, tablet or on a smartphone.

Simple User interface

Enable your site staff to enter data rapidly and accurately with logical user flow and form rules like edit checks. Calculated variables ensure that figures (BMI, imperial to metric, etc.) are always reliable.

User Roles

All roles have access to Trial Online with defined permissions and when logged on, the system provides a clear project overview, specific To Do list and email alerts. The system offers a possibility to connect eTraining to each role, to enforce user-training prior access to the production environment and to have a consolidated view of training records.

Data is saved automatically

Store each value automatically once it is entered. No risk of losing data due to inactivity. Edit checks triggered directly for cleaner data. More effective monitoring and cleaning process.

Construction of eCRFs

The eCRFs are created in a construction module that is a stand-alone software This module offers a fast and easy way to build eCRFs and edit checks, with flexibility and format, where no prior programming skills are required. The module includes a library function where you can store and reuse standard forms.

Edit checks

Trial Online ensures the validation of data entry through edit checks that can be set to trigger directly when an “incorrect” entry has been entered, or in batches at regular intervals. Edit checks are easily specified in the Construction Module.

Queries

CRAs, Data Managers and Medical Coders can create queries and forward them to the investigator/coordinator who will be alerted within the system or via a system-generated email.

File import

Laboratory files can be imported into Trial Online. It is possible to upload images, videos and other binary files in Trial Online. Files may be assessed by an independent investigator in the system.

Reports & Exports

Trial Online includes several types of reports to simplify the overview, monitoring and security of the trial. In Trial Online the user can also create and customize additional reports. The Status Report Summary gives the user insight to work flow navigation and a visual overview of patient status. Trial Online supports the export of data to the following formats: SAS, ASCII, Excel and PDF.

Audit trail

A complete audit trail is maintained from data entry through all changes in the system. The Trial Online system supports the audit trail review by providing reports and exports for both the eCRF and system settings audit trails.

Frequently asked questions

What are the core functionalities of Trial Online EDC?
Trial Online EDC is designed specifically for the needs of extensive clinical trials. It is a robust and secure while still intuitive system that accelerates clinical study 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?
Yes. Trial Online EDC 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?
Yes. Our EDC supports all major web browsers such as Google Chrome, Microsoft Edge, Firefox, Apple Safari etc. The system includes responsive web design and works perfectly well on tablets, as well. The system can be used on smartphones; however, we do not include that in our testing.
Can the EDC system be customized to meet specific study requirements?

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.  

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 to be easy to use, which means that you don’t need any prior experience as a Clinical Data Manager to set up your trial as the full process is self-explanatory. Our Data Management team can also assist you throughout your study journey, from co-building your first study to providing ongoing knowledge transfer and training. We offer continuous support throughout your study to ensure a smooth and efficient experience.
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 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.

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?
Yes, 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, Suvoda and Veeva RTSM.

Regulatory Submissions

From ICH/GCP and 21 CFR Part 11 to GDPR and HIPAA, we provide you with complete confidence that your data is compliant with our tools, so you can focus on the trial. To ensure data security over the internet, Trial Online features 256-bit HTTPS data encryption.

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Seamless Compatibility:

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Business Development

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