Clinical development is a costly and time-consuming milestone in the complex process to bring new treatments to patients. Developing a clinical trial protocol is a critical step in this process. Poorly conceived protocols create challenges at the study level, the program level and across the full lifecycle of development and commercialization. Study level challenges typically include protocol amendments that can add nearly USD 500,000 in unplanned expenses and 61 days to a trial timeline1 and patient recruitment difficulties.
Decision making during protocol design can often feel like high impact prediction using limited and sometimes biased data. Fortunately, data to inform the trial design process exists — clinical researchers just need easy access to the right information in order to add more patient data and evidence-based insights to the protocol design process.
IBM® Study Advance helps you build quality protocols by providing the power of collaboration, AI and and real-world data to enable efficiency and informed decisions across protocol design and development.