Our client was a biotech company whose clinical pipeline was expanding with teams across clinical operations, biometrics, safety, and translational sciences. All these organizations and departments were drowning in data. Every week, teams stitched together different PowerPoint decks, SAS listings, spreadsheets, and extracts from central labs, CTMS, and warehouses. The problem was not a lack of data but a lack of timely insights. We were constantly asked which sites were falling behind, whether there was any worrying safety drift, or which biomarkers were correlating with response. Analysts would manually rerun scripts or pull static listings, which resulted in delays ranging from two weeks to a month. There were also many inconsistencies in definitions between ORR, PFS censoring rules, and protocol deviation categories, causing confusion and rework. Our client wanted a single analytic environment to serve as a one-stop place where their teams could explore, visualize, and collaborate in real time while maintaining security and regulatory expectations. TIBCO Spotfire became their live analytics workspace. Previously, teams had to collect emailed spreadsheets and various documents. By having one combined place, teams could open dynamic dashboards that were directly governed by curated datasets. The data canvas showed every transformation step, which helped the client maintain traceability for audits. Data functions written in R or Python allowed statisticians to encode and have approved analytic methods that could be used everywhere. Before implementing the tool, we built a framework and strategy. First, we mapped their high-value pain points including trial enrollment forecasting, safety drift monitoring, protocol deviation detection, and biomarker response analysis. Based on these priorities, we defined common language and common rules by aligning calculations with CDISC standards and creating shared data functions for lab shift rules and biomarker classifications. This prevented inconsistent interpretations across studies. We then built the technical foundation by connecting TIBCO Spotfire securely to their EDC, R environment, data lake, and row-level security to ensure adherence to PHI, PII, and regulatory compliances. Clinical operations dashboards provided real-time insights into enrollments and deviations. Safety dashboards were deployed to visualize patterns, biomarker distributions, and tumor burden changes for their cancer-related drug studies. The business validated the dashboards based on GxP principles, and we trained the study teams and built new templates so that trials could launch analytics much faster.
