PRS / ClinicalTrials.gov
Early on in the clinical trial disclosure initiative, many in the pharmaceutical/biotech/medical device industry naively believed that when a legislative bill was signed into law, we could confidently put internal compliance procedures in place without worry that the law would change in the near future. Unfortunately, our innocent views of legislative processes were soon altered when Maine changed its initial clinical trial disclosure requirements. Now, clinical trial disclosure laws and regulations (local, regional, and global) seem to evolve on an almost-daily basis.
Additionally, there are continual changes with the Protocol Registration System (PRS) and ClinicalTrials.gov. We must continually update our platform and data utilities to ensure our clients data is properly posted in a timely manner. We typically post data 1-2 times per week for each client and are also available for emergency uploads.