Managing an eTMF (electronic trial master file) is difficult. Some organizations, however, impose burdens on themselves by employing practices that are inconsistent with Health Authority guidance. In this blog,  we examine common myths and provide specific agency guidance that debunks these “myths.” So without further ado, let’s get to it! Myth 1: We must do […]

Even though it costs over $40 million (roughly 50% of the typical trial budget) to reach phase three of research, as many as five out of ten clinical trials fail. Yet trial complexity is increasing, with the number of procedures per protocol increasing dramatically in recent years. Regulations on trial data quality supervision continue to […]

Life sciences companies are facing increasingly difficult times. Consumers and policymakers are putting increasing pressure on the pharmaceutical industry to slash medicine prices, reduce time-to-market for new drugs, and comply with increasingly onerous regulations. As a result, the clinical research ecosystem is attempting to improve trial outcomes and patient experience while lowering trial costs, better […]