Regulatory Compliance

ClinSource is the solution provider for the life science industry, supporting medical device-, pharmaceutical-, and biotechnology companies to increase efficiency in clinical development.

ClinSource TrialXS can be used in full compliance with the standards, directives and legislations that apply to Clinical Investigations.

Our EDC managers are dedicated to support the customer in becoming and remaining compliant with 21 CFR Part 11 for electronic records and electronic signatures, ICH-GCP and ISO 14155-1.

 

Easy

ClinSource ™ - Data Capture Made Easy

ClinSource is the solution provider to the life science industry, supporting medical device-, pharmaceutical-, and biotechnology companies to increase efficiency in clinical development. We do so by focusing on 'ease of use' in the confirmatory stage (late phase, post-regulatory) and operational integrity in the exploratory stage. By ensuring happy users in TrialXS Confirm and regulatory compliance in TrialXS Explore!

 

TrialXS ™ Confirm and TrialXS ™ Explore

Smooth data collection starts with our intuitive and user friendly Electronic Data Capture
solution TrialXS /EDC.

  • User friendly

Medical practitioners like our electronic Case Report Form.

  • Proven

Used in 55 countries in over 200 projects.

  • Reliable

Operational integrity through continuous performance monitoring and a redundant hosting
infrastructure.

  • Scalable

Start a single project or scale up to multiple projects on the same platform.
With TrialXS Confirm and TrialXS Explore we adapt to your needs.

And...our experienced staff will assist you during the implementation and conduct phase
to make Electronic Data Capture easy, and to assure that your experience with TrialXS will be a positive one.