Ensuring Good Clinical Practice in Clinical Trials through Laboratory Qualification
Colibri Scientific has a range of pre-qualified laboratory partners with differing specialities; however, some analyses may require a niche laboratory or the sponsor’s preferred laboratory.
We apply a risk-based approach to laboratory qualification, depending on the intended use of the resulting data.
Our thorough qualifications ensure that method validations are robust and conform to the FDA and EMA regulation guidelines, staff are adequately trained, instruments are well maintained, the laboratory is well managed and complies with:
If you’re looking for expert support in laboratory qualification to ensure compliance with FDA and EMA guidelines, or if you require assistance in partnering with a specialised lab, contact us today or submit an enquiry at info@colibriscientific.co.uk.