Clinical Trial Translations:
New Requirements for Localization Under the European Union Clinical Trials Regulation (EU-CTR 536/2014)
The new EU-CTR has been crafted to harmonize the submission, assessment, and supervision of clinical trials with new objectives and guidelines. With these massive regulatory changes taking effect now in EU, this white paper highlights some of the specific changes that will dictate how clinical trials are conducted going forward and what applicants can expect from the updated approval process, particularly where support from language service providers (LSPs) will prove essential.
