Overcoming confidential information challenges faced by study sponsors today

Abstract

As health authorities aim to increase clinical trial transparency and visibility to the public, pharmaceutical manufacturers are facing new pressure points. New regulations require the disclosure of clinical trial application data, many of which contain sensitive and confidential information about company intellectual property including, but not limited to, its manufacturing methods, drug composition, names of suppliers, and future development plans. Many manufacturers are examining their processes to minimise references to this confidential data during the document authoring process and how they track and identify confidential information throughout the study lifecycle. This has created a catalyst for medical writing, transparency, legal, and regulatory teams to collaborate and enhance their processes to minimise disruption to the trial approval process while embracing the opportunities to share more with the public.