We closely collaborate with federal, state and local regulatory agencies to obtain an approval of study documents within an expected time frame. We provide regulatory supervision during study conduct which is essential to implement amendments and additions to the study protocol while meeting the most current regulatory requirements.
Our flexible and responsive Regulatory Affairs team ensures that the projects for which the responsibility is transferred always comply with the regulations and laws pertaining to clinical research. We support our customers in all central and local application activities, including the identification of suitable trial sites, the preparation of trial-specific essential documents, the submission of study protocols and related documents, regulatory maintenance during the study conduct and end of trial notification.
