Patient Safety has become a critical component among the many core processes of Life Sciences organisations due to ever increasing Regulatory & Compliance expectations and continuously evolving guidelines. It is also becoming imperative to minimize risks associated with carrying out complex clinical trials involving huge budgets running into more than a decade. Hence, it is important for Life Sciences organizations to implement an effective pharmacovigilance system in order to protect their patients from the adverse events and also can increase the success rate of the clinical trials. In order to get a system successfully deployed to pro-actively manage the pharmacovigilance, it is also important to get the adoption of all key stakeholders from the eco-system such as regulators, pharma companies, physicians and patients for the success.
With increasing regulatory expectations and even greater scrutiny on various aspects of Life Sciences business, this industry face significant pressure to maintain the high degree of quality in their complete eco-system. These organizations, in order to maintain top level of quality, need to design and implement robust Quality Management Processes which eventually delivers a number of critical benefits such as superior quality, regulatory compliance, reduce costs and thereby provide competitive advantage & superior business performance to these organizations.