Home - Replior AB - Clinical Trial Software and IT Operation Services

Replior is a Swedish IT Operations provider focused on the Life Science- and financial sector.

Our customers share an extensive demand in data integrity, data protection and service availability.

Our business is based on two independent pillars: Quality Assured IT Operations and Software Services for clinical trials with Trial Online EDC and Trial Online ePRO.

News

We have published an article, “eCRF and GDPR Compliance”

Clinical Trial
Software Services

Replior’s Clinical Trial Software Services is operated through Trial Online

Trial Online EDC has been in operation since the beginning of 2000, as a trusted eCRF provider for thousands of clinical studies made over the years, from small Phase I trials to global Phase III/IV trials.

Trial Online ePRO provides Patient diary and questionnaire service to clinical studies.

Quality

Trial Online is a designed, developed, and tested computer system as defined in PIC/S ‘Good Practices for Computerised Systems In Regulated “GxP” Environments’.

And Trial online is of course compliant with FDA 21 CFR Part 11.

Our Quality Management System is built on quality standards in the industry, e.g. guidelines and directives provided by ISPE, FDA and EMA.

Replior and Trial Online are audited regularly by its clients (regulated companies).

Trial Online EDC and Trial Online ePRO is owned, developed and qualified by Replior AB.

Trial Online EDC

Fast and easy data collection

TrialOnline EDC

All Trial Online activities are managed online 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.

Learn more

Trial Online ePro

Better data faster

TrialOnline ePro

Trial Online ePro lets you run the trial you want, and not the trial your system allows you to.

Assign defined user roles for an easier management, and automatic notify user about specific events. Divide questionnaires into time and date defined events, and get better insights faster

Learn more

We provide tailored, quality assured, IT Operations services to the Life Science- and Financial sector with extraordinary data integrity and data protection services.

We are one of few flexible and independent hosting providers in the EU that are fully compliant with the rules and regulations in the pharmaceutical industry and GDPR.

Data Centre

IT-infrastructure elements are placed in a data center facility that is embedded in the Swedish bedrock. This ensures extremely tough physical protection.

Access to the facility is only granted 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.

Server services

We customize the server solution to meet our Customers demand with a service that is secure and easy to scale when the business grows. The production environment is fully redundant with regards to production servers, storage, networking and security.

Backup and Archive

The backup service is configured to provide the most cost efficent and secured backup for the specific task. An application server may have fewer backups done per day and a database may be backed up continously to ensure data continuity.

Data that needs to be securly Archived and not accessed frequently is stored in our long term Archive service.

Encryption, data retention etc is configured together with the Customer.

Monitoring

Replior monitor service performance 24/7 and will initiate troubleshooting if malfunction is suspected or reported. Service performance issues can be reported to Replior by phone or e-mail 24/7.

IT Operations

resources

Replior is a Swedish IT Operations provider focused on the Life Science- and financial sector. Our customers share an extensive demand in data integrity, data protection and service availability.

We have offices in Stockholm-Sweden, Lund-Sweden, Split-Croatia and Singapore.