Compliance

Quality & Compliance

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

Our services and products shall always meet our customers’ and users’ expectations and requirements. By understanding our customers’ needs today and, in the future, we deliver competitive services and products with the right quality, on time and according to agreed terms. A cornerstone for our quality work is an engaged and aware staff and the company’s collective knowledge and rules.

All 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 follow these guidelines as well as industry standards to ensure product quality. This includes Software Development Life Cycle, System Qualification, and Quality Assurance Testing.

Trial Online is a designed, developed, and tested computer system as defined in PIC/S ‘Good Practices for Computerised Systems in Regulated “GxP” Environments’. Trial Online is compliant with FDA 21 CFR Part 11, GDPR and HIPAA. Our Quality Management System is built on quality standards in the industry, e.g. guidelines and directives provided by ISPE, FDA, EMA and ICH.

Our independent Group Compliance Officer performs regular internal audits on Replior and Complior. Clients (CROs and Sponsors) regularly perform audits of Replior and Trial Online.

We are dedicated to delivering 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
  • International Council for Harmonisation (ICH)”, E6 Guideline for Good Clinical Practice

For new major releases of the product, step from development, verification, and release include, but is not limited to:

Development projects, (releases) are planned, executed and reported as follows:

  • Project Plan
  • Project Report
  • System Specification
Testing is planned, executed, and reported as follows:
  • Test Plan
  • Test Report
  • Test Results

Following a completed release the following documents are provided:

  • FDA 21 CFR Part 11 Fulfilment Report
  • GDPR Fulfilment Report
  • System User Manuals
  • Installation Qualification
  • Release Notes
  • Release Statement