About

Trial Online 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.

About Trial Online EDC and ePro 
Trial Online EDC has been in operation since 2000.

In early 2016 Trial Online ePRO was launched. Trial Online ePro can be used as an integrated service with Trial Online EDC or as a stand-alone service.

Trial Online is owned by Replior AB, a Swedish IT Operations provider focused on the Life Science sector.

Operational services includes Managed Hosting, Backup Services, Security Services and Communication Services. Replior furthermore provide hosted software services for the Life Science industry.

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. This includes perimeter access, redundant electric power with n+1 diesel generators, redundant cooling, EMP/HPM protection and more.

Fast

  • 100% Web-based EDC and ePRO
  • 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
  • Cost-effective even for small MedTech and BioTech studies
  • Easy construction of Data Sets – adaptable data export
  • E-training

Quality

Quality is the heart of everything we do, and it has to be!

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).

Quality & Compliance

We are dedicated to deliver a service of the highest quality in all aspects of our operation. Furthermore we continually try to meet, or exceed, all expectations of our customers. From development, through general product release, we have a high focus on quality and compliance. We have accomplished this by leveraging the latest technological solutions and regulatory standards such as:

  • US FDA: Title 21 CFR Part 11, Electronic Records and Electronic Signature
  • US FDA: Guidance for Industry for Computerised Systems Used in Clinical Investigations
  • US FDA: Title 21 CFR Good Clinical Practices
  • International Conference on Harmonization(ICH), E6 Guideline for Good Clinical Practice

Product Quality

All systems and processes used to manage a clinical trial are a part of a regulated process that must be validated and needs to meet both FDA regulations and ICH guidelines. All Trial Online’s products follows these guidelines as well as industry standards to ensure product quality. This includes Software Development Life Cycle, System Qualification, and Quality Assurance Testing.

Therapeutic Experience

Trial Online has conducted over five hundred studies in a wide range of therapeutic areas. Our software can accommodate the most complex of clinical trial designs, with an easy and time saving set-up. Conducting a study has never been easier.

  • Allergy
  • Auto-Immune Disorders
  • Bio-defense
  • Cardiovascular Health
  • Dermatology
  • Endocrinology
  • Gastroenterology
  • Hematology
  • Hepatology
  • HIV/Infectious Diseases
  • Immunology
  • Musculoskeletal
  • Neurology
  • Oncology
  • Ophthalmology
  • Orthopedic
  • Pain Management
  • Respiratory

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