Biological medicines (biologics) have made substantial contributions to the treatment of many chronic and serious diseases such as cancers, chronic inﬂammatory diseases and some rare genetic disorders, and are expected to provide signiﬁcant therapeutic beneﬁts to many patients who would otherwise have had limited treatment options.
We are all aware that what we know of Pharmacovigilance today will radically transform in the future with the use of automation and technology tools. Companies that implement these tools in their PV operations can experience greatly improved efficiency, compliance and quality.
Pharmaceutical customers today are challenging pharmacovigilance service providers to deliver greater value for the funding they provide. Not surprisingly, service providers are addressing this need by investing in technology and automation tools that are poised to increase both the efficiency and quality of pharmacovigilance operations.
Over the last 10 years, clinical trials have changed substantially in response to increasing globalization and study complexity, along with new technological capabilities and industry guidelines,7. With these noticeable transformations, sponsors are increasingly revisiting their monitoring methods to uncover new efficiencies and develop more robust risk management processes that can enhance …