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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.

Contact us and Schedule a Demo!

Don't hesitate to contact  us with any question or to schedule a Trial Online demo!

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Trial Online EDC 5.0 in the making. Smarter, more efficient. Release in 2016! All new, state of the art, ePRO service launches in April 2016! Trial Online ePRO will be integrated with EDC or Stand alone!

Since 2000

Trial Online is owned by Replior AB and have been serving clinical trials with EDC, hosting and backup since 2000.
Replior provide three to four new, customer driven, releases annually.

Fully compliant

Trial Online is a designed, developed, and tested computer system as defined in PIC/S ‘Good Practices for Computerized Systems In Regulated “GxP” Environments’ and is compliant with FDA CFR 21 Part 11.
The 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.

Hosting and backup included

Trial Online is provided as Software as a Service, SaaS solution on a server dedicated to the client. The server is managed and hosted by Replior and is easily upgraded with more power if needed. Backup is done once every 24h with IBM TSM and include a Disaster Recovery image.

  • FAST FACTS

  •  100% Web-based EDC
  • Clients may perform all activities themselves
  • Easy and fast set up of the complete system
  • Fully compliant with 21 CFR part 11 and GCP
  • Hosted on secure dedicated server
  • User-friendly
  • 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
  • E-training
  • SERVICE DESCRIPTION

Web based

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.

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.

User Roles

All roles have access to Trial Online with defined permissions and passwords. When logged on, the system provides a clear project overview, specific To Do list and email alerts.

  • Investigator
  • CRA/Monitor
  • Sponsor
  • Trial/System Administrator
  • Assessor
  • Coordinator
  • Data Manager
  • Medical Coder (MedDRA and WHO-DDE coding)

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.

Reports

Trial Online includes several types of reports, which 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.

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

Audit trail

A complete audit trail is maintained from data entry through all changes in the system. The Trial Online  system includes many types of reports that simplify the overview, monitoring and security of the trial and additional, customized reports are readily available.

Security / Regulatory

Trial Online is compliant with FDA 21 CFR part 11. Trial-on-Line also corresponds to GCP and FDA’s Guidance of Computerized Systems Used in Clinical Trials. To ensure data security over the internet, Trial Online features 256-bit https data encryption. The user is automatically logged out if no activity has been noticed during a predefined time.

  • IT Operations

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.

Server Hosting

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.

Backup

Backup is made on the entire Trial Online server once every 24 hours to Repliors main backup system, running IBM Tivoli Storage Manager. A secondary backup system, the Disaster Recovery system, maintains a copy of the primary backup system and is situated in a different fire cell from the primary backup system. Backup scope and retention policy can be tailored upon agreement with the client.  Backup restore is made by Replior and can be tested regularly if agreed upon.

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.


  • ABOUT US


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.

Postal Address:
Replior AB
Hammarby Kajgata 12
SE-120 30 Stockholm, Sweden

Visiting addresses:
Malmö, Västkustvägen 7
Stockholm, Hammarby Kajgata 12

Phone: +46(0)8 – 601 13 30

E-mail: info@replior.se

Web: http://www.replior.se (currently only in Swedish)


  • CONTACT US


Don't hesitate to contact  us with any question or to schedule a Trial Online demo!

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Country

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