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As far back as the late 1800s, when the eclinical landscape was an infant, all of the savvy companies paying for clinical trials agreed on one thing. Every research system for every trial must have its own database. This seemed smart at the time. Randomization data? Its own database. Case report form (CRF) data? Separate database. Monitoring reports? Separate database. Drug safety information? Separate database. The multiple-database approach gave birth to a problem. Suppose a clinical trial manager asked, Is there something that our clinical sites don’t understand about our adverse events? No Answers Such an ostensibly simple question might require heretofore isolated systems to communicate. Which is easier said than done. That apparently simple question could flummox the IT department of a clinical development organization with more revenue than a moderately large Latin American country. Indeed, when the companies paying for clinical trials asked for small databases to communicate, formerly…more...
