Trial Online is dedicated to delivering a service of the highest quality in all aspects of our operation, and to continually meet or exceed the expectations of our customers for quality and performance.
From development through general product release, we have a high focus on quality and compliance, and 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 Computerized Systems Used in Clinical Investigations
US FDA: Title 21 CFR Good Clinical Practices
US FDA Gl: General Principles of Software Validation
International Conference on Harmonization(ICH),E6 Guideline for Good Clinical Practice
Clinical Data Interchange Standards Consortium (CDISC) and Health Level 7 (HL7)
Microsoft Technology Solutions
The systems and processes used to manage a clinical trial are 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 including Software Development Life Cycle, System Validation, and Quality Assurance Testing to ensure product quality.
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SE-120 30 Stockholm