Clinical Research Phases
The clinical trial process can take many years, and the timeline for readiness to submission for market approval varies with the efficiency of the clinical trial process. Once a product has reached the market, the research on that product can continue, encompassing studies around additional safety and efficacy profiles, new indications and the effects on patient sub-populations.
Trials at each phase have their own requirements and challenges, and the medical and commercial success of a treatment can be determined by the sponsor's ability to navigate through the process safely and speedily, collecting scientific data, analyzing it and reporting it, within real-life resource constraints. Medidata's products have been specifically designed to be configurable for all clinical phases, from clinical development—Phase I, Phase II, Phase III—to peri- and post-approval—Phase IIIb, Phase IV, registries, large observational studies and other studies. In addition, Medidata products can help sponsors create new efficiencies across the process, by creating study configurations once, reusing study elements and creating standards libraries that can speed study start-up in all phases.