Introducing Clinical Trials 2.0: An Integrated Solution To Support The Clinical Trials Of The Future
Most scientific discovery begins with a simple question: “What if...?” Indeed, the question has been the genesis of pharmaceutical breakthroughs ranging from the discovery of Aspirin, the introduction of Good Clinical Practices (GCP) to the invention of Electronic Data Capture Systems (EDCs).
Yet “What if?” is not asked often enough in clinical operations. “What if we had today’s technologies 25 years ago when GCP guidelines were adopted? Would we do things differently today?” “What if our resistance to change isn’t rooted in regulations, but in our own reluctance to challenge the status quo?” “What if we design our processes around what technology can do, rather than the other way around?” And lastly, “What if we calculate the cost of not doing something as opposed to the cost of doing it?”
Here we explore the value of taking a fresh approach to clinical data management and its associated systems – and ultimately the processes and roles that surround them. With the right technologies in place, companies can re-invent the traditional roles of Clinical Research Associates (CRAs) and Data Managers to reduce trial costs and timelines.
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