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
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.
Hammarby Kaj 18
SE-120 30 Stockholm