Clinical trial sponsors are required to register trials and report trial results information to various registries and health authorities around the world. Requirements vary from registry to registry and most sponsors don’t have a global view of their compliance efforts, how they are performing against local laws or their own internal policies. In part, this is due to the fact that large global companies “hand‐off” local disclosure to affiliate organizations. For some organizations, desktop tools like spreadsheets are used to manage disclosure. Maintaining a “master” spreadsheet that everyone can view and edit isn’t easy and often leads to bottle‐necks and delayed updates, resulting in some individuals creating their own versions with inconsistent data.
Disclosure, compliance and transparency have become topics of concern for senior leadership teams as transparency advocates and industry watchdogs start to publish score cards and other content that publicizes and compares disclosure performance across the industry. These efforts toward greater transparency are supported by patient advocates, researchers and the financial community. Because of increased publicity in industry as well as the general press, global disclosure is no longer just a compliance concern. It is now a formal topic of discussion in the Csuite.
The following paper discusses the challenges of tracking global disclosure performance and how clinical trial sponsors can use Atlas Global Compliance to manage track and reduce the risks of non‐compliance.