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Pharmacovigilance in a box
SciVigilance: Pharmacovigilance in a box
Effective safety and risk management is a result of a multi-tiered effort that ensures the safety of a product and mitigates the risks for pharmaceutical companies. While pharmacovigilance depends extensively on human sources for information input and processing of data, the growing volume of data and evolving regulations necessitates robust technology enabled process execution to manage the myriad of risks. Streamlined and agile processes ensure consistent quality, improved efficiencies, adherence to timelines and regulatory compliance. The synergistic combination of process expertise and domain knowledge facilitates swift and effective decisions in all facets of product life cycle.
Technology and process enhancements play a crucial role in effective management of pharmacovigilance. Technology fosters collaboration between disparate teams, enables seamless flow of data, intuitive collection, processing and analysis of data. Cumulatively, effective combination of domain expertise, agile process and robust technology has allowed us to consistently demonstrate time savings, high quality, cost reductions, increased efficiency and absolute compliance. At the project level, technology allows tracking risk-benefit profile in near real time and helps in informed decisions on risk minimization much faster, ultimately leading to more efficacious medicines.
The whitepaper examines the use of scientific expertise, LEAN process and technology to deliver enhanced efficiency and compliance.