Clinical trial disclosure is no longer just a checkbox requirement for regulatory teams. It\u2019s a high-stakes mandate that impacts a company\u2019s integrity and speed to market. Even minor delays and data inconsistencies can lead to significant compliance risks, including heavy fines and drug approval delays.\n<\/p>\n
\nBayer\u2019s legacy disclosure solution had to exchange data with other systems and sources, at times leading to fragmented, disconnected processes. With Veeva Disclosures, the team now has a single source of truth that automatically flags data inconsistencies and reduces time spent on registry updates by up to 50%.\n<\/p>\n
\nFor years, Bayer relied on a disclosure system heavily customized to meet specific needs. Although the environment was familiar, the highly tailored system couldn\u2019t easily evolve to meet modern data requirements.\n<\/p>\n
\n\u201cIf you have too much customization, it gets more difficult for your system to grow and change with you,\u201d explains Thomas Loeber, clinical trial posting lead at Bayer.\n<\/p>\n
\nThis custom solution pulled information from many different sources with complex integrations. Staff often had to contact colleagues across the organization to retrieve study information. This manual effort strained internal resources and complicated data auditability.\n<\/p>\n
\nDisclosure compliance is a key part of Bayer\u2019s transparency initiatives to show integrity to patients and healthcare professionals. To support this, Thomas\u2019s team chose a solution that would fit into their existing ecosystem.\n<\/p>\n
\n\u201cWe were looking for the best disclosures application that also fit into our existing clinical landscape,\u201d says Thomas. Implementing Veeva Disclosures helps Bayer minimize the number of complex integrations, lower IT costs, and reduce reconciliation timelines.\n<\/p>\n
\nReducing manual, duplicative entry simplifies registry updates. For example, Thomas recently updated a study start-date on a ClinicalTrials.gov submission. With Veeva Disclosures, he could cut the time on this routine update by half to just a minute or two.\n<\/p>\n
\nInstead of spending time on manual tasks and data reconciliation, the team can now focus on ensuring accurate, compliant disclosures. Thomas notes that \u201cif something works reliably and well, you can focus on the content you\u2019re changing rather than trying to make the system work.\u201d\n<\/p>\n
\nUnder the legacy model, inconsistencies between the source data and disclosures often went unnoticed until late in the process. With a unified platform, teams can update the source of truth in Veeva CTMS to ensure data integrity across the company.\n<\/p>\n
\n\u201cNow that we\u2019re using data directly from our CTMS, Veeva Disclosures highlights missing and inconsistent data that we wouldn\u2019t have noticed so quickly,\u201d says Thomas.\n<\/p>\n
\nWorking within the Vault environment also simplifies how Thomas\u2019 team interacts with clinical and regulatory colleagues. With a single document library, the team no longer needs to manage duplicate files in multiple locations.\n<\/p>\n
\nEstablishing a single source of truth does more than simplify compliance \u2013 it bridges the gap between historically siloed teams. \u201cWhen trying to understand how to connect more closely with our colleagues from a technology and system perspective, disclosures filled that gap,\u201d Thomas explains.\n<\/p>\n
\n\u201cNow that we\u2019re using data directly from our CTMS, Veeva Disclosures highlights missing and inconsistent data that we wouldn\u2019t have noticed so quickly.”
\n– Thomas Loeber, Clinical Trial Posting Lead, Bayer<\/span>\n<\/p><\/blockquote>\nNext steps on Bayer\u2019s disclosures journey<\/h2>\n
\nAfter a successful rollout of United States registrations, Bayer will expand Veeva Disclosures to EU studies. In addition, the team plans to use advanced workflows to automate structured data and improve connectivity across Veeva eTMF, CTMS, and RIM.\n<\/p>\n