Quality standards for the performance of clinical studies have progressed enormously in the past 20 years. Step by step, MEDIDATA has kept pace with this development. Continuous updating of our SOPs guarantees that new guidelines or legal regulations are promptly implemented in practice. Close cooperation with the QA departments of large internationally operating clients has been helpful for SOP development in many instances.

When working for large client companies, we typically use their templates. Our expertise and habitual observance of high quality standards allow us to adapt them fast and flexibly to particular study requirements.

For investigator-initiated studies, we offer formal and legal advice in planning, preparation, and coordination. We currently manage several such projects, overseeing GCP and AMG compliance.