Secure, Powerful, and Cost effective ePRO and EDC service
There is a growing need for easy to use, cost effective and trustworthy
Electronic Data Capture, EDC systems.
Trial Online is an EDC system that meets all three criteria.
Appreciated for its ease of use and cost effectiveness.
Trial Online is fully compliant with industry & regulatory standards and
provides features to ensure data security and accuracy.
Medical coding: MedDRA and WHO-DD
Flexible and fast eCRF design
Facilitates networking with specialists and partners
Efficient and cost-effective even for small trials
Easy construction of Data Sets – adaptable data export
All Trial Online activities are managed on the Internet and offer a modern and easily accessible platform for all involved in a study. No special hardware or software is required to run the service, which utilizes standard internet browsers. Since the start-up time and creation of electronic Case Report Forms is very short, Trial Online can be used for all trials, regardless of size.
Construction of eCRFs and edit checks
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 in design and format. The module includes a library function where you can store and reuse standard forms. The eCRFs are easy uploaded in the Trial Online interface. Changes in the eCRFs during an ongoing trial is also possible and easy to handle.
Functions in Trial Online
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. Trial Online offers a paperless query tool to generate, resolve and track queries online. 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.
Laboratory files can be imported into Trial Online. Excel, SAS, ASCII and PDF are standard export formats in 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.
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
Replior AB manages the IT Operations of the Trial Online service. IT-infrastructure elements is placed in a data center facility that is ensconced in Swedish mountain bedrock, with extremely tough physical protection. Access to the facility is granted only after registration and authorization on site. Power is provided with redundant UPS backup and diesel generator backup (n+1 in accordance with TIA 942 Tier 2). The physical environment within the facility has regulated temperature (22 degrees C +- 5 degrees) and humidity (50% +- 10%) with redundancy. Every technical space is a separate fire cell.
Trial Online is supplied on a dedicated virtual server to the client. The virtual servers are run on a redundant layer of production servers utilizing VmWare to build the virtual servers. Storage is redundant with IBM SAN. Each delivery of Trial Online is protected by a redundant firewall cluster.The servers performance is easily upgraded if needed.
Trial Online is hosted in Sweden and governed by Swedish law.
Replior is a Swedish IT Operations provider focused on the Life Science sector. Operational services includes, Managed Hosting, Backup Services, Security Services and Communication Services.
Replior provide hosted software services for the Life Science industry. One is Trial Online EDC, a Web-based EDC service, fully compliant with 21 CFR part 11 and GxP. Replior own, maintain and continuously develop and test Trial Online.
In early 2016 Trial Online ePRO is launched as an integrated service with Trial Online EDC or as a stand-alone service.
Abiocess is a tailored Web-based service for collaboration and document management constructed in accordance with the eCTD file structure.
All production equipment is hosted in a high security Data Center providing extremely secure environment for IT-operations, including perimeter access, redundant electric power with n+1 diesel generators, redundant cooling, EMP/HPM protection etc.
Hammarby Kajgata 12
SE-120 30 Stockholm, Sweden
Malmö, Västkustvägen 7
Stockholm, Hammarby Kajgata 12
Phone: +46(0)8 – 601 13 30
Web: http://www.replior.se (currently only in Swedish)