Regulatory Strategy for Clinical Trials in the European Union

Setting up a clinical trial in the European Union has always been a time-consuming business. Necessitating country-specific reviews and approvals for each of the 27 member states, it has very often been a daunting mission.

However, with the implementation of the new Clinical Trial Regulation, change is now underway. In addition to the drafting of core documents, a review of local legislation is required.

The Principal Investigator’s CV, the Participant Information Sheet (PIS) and the Informed Consent Form (ICF) may need to be provided in each member state’s local language, and some local forms and documents may also be required

We help our life science clients to navigate these language requirements and maintain regulatory compliance. Knowledge of both the language and the subject matter are vital to ensure there is no confusion about major concepts, which can otherwise result in significant delays and even rejection by regulators.