Leveraging abundance of information available from internal and external
sources, the industry needs a transformational strategy by making a move from a retrospective modus operandi to a more predictable and proactive action oriented clinical research and development model; wherein key stakeholders can proactively plan and act in time rather than analyzing the outdated information on what happened in the past. Knowing the unknowns is important for an accurate and informed decision to be made , be it in a timely manner with an optimal use of resources will help to maintain integrity of decisions and balance the desired benefits. Industry has either looked into this aspect or started to adopt manual solutions or has just realized the need for one unified solution. Some of the evolving business scenarios center around either the planning, operational, or clinical activities but not one is integrated. Operations performance indicators including but not limited to study start-up, enrollment, data acquisition rate, site close-out, etc are large variables on the competence of the executing CRO/s and provide primitive information based on hybrid approaches. Quality management and regulatory information management are equally vulnerable. Areas that get the most attention are the clinical performance indicators where there is maximum levy due to its key performance indicators, being safety and efficacy. Industry is quickly transitioning from traditional conduct of clinical trials to more agile and adaptive designs. Learning the effects of study design early in the trial phases and identifying what works and what doesn't can save huge time and costs as well as allow sponsors to conduct trials with minimum patients using the dosage that will work. So there are enough motivations to pursue the adaptive designs but industry still remains at the stage of not having the right infrastructure that can support such information management and the decision-making process in an integrated fashion. Find more information.. http://www.maxisit.com/