INSIGHTS ON CLINICAL TRIAL REGULATORY ISSUES

CLINICAL TRIAL REGULATORY SOLUTIONS

  • Our regulatory affairs experts guide you through the entire drug development and regulatory submission process to help you achieve regulatory success.

  • Delivering safety surveillance before and after regulatory approval for pre-approval and marketed health products.

  • Preparing regulatory marketing applications to their successful conclusions is our focus.

  • IBC review involves the deliberate transfer of engineered genetic materials to human research subjects. Read our latest brochure on IBC review.

  • To mitigate the uncertain clinical trial landscape and make better data-driven decisions, clinical development groups have turned towards real world data (RWD) to augment and inform their understanding of the disease and treatment landscape. Integrated Evidence from Acorn AI provides access to a one of a kind cross-sponsor, regulatory grade, patient-level clinical trial dataset with pre-integrated real world assets to help clinical developers make critical data-driven decisions throughout the product development lifecycle and increase their probability of success.