Uniform standards for AEs to build stronger AE data
Global and regional healthcare institutions like the ICH, WHO, FDA, and European Medicines Agency (EMEA), have clearly defined the standards for identifying and reporting Adverse Drug Events (ADEs). These include AE definitions and guidelines for reporting, collection of AE data in registries, standard nomenclature for event coding, and AE management.
However, even after such comprehensive uniform standards, the level of AE reporting does not remain uniform globally. Therefore, the primary objective of the healthcare systems should be to enhance awareness regarding AE reporting not just among HCPs but also among the general public, with a specific focus on developing countries.
For service providers like Wipro, there is also a major need to adhere to the established uniform standards. Our case processors must have competence to assure correctness and consistency because they are in charge of processing AE data and coding AEs into a standard nomenclature. By using coding conventions such as MedDRA to code the exact terms, we can capture the core data accurately, thoroughly, and in a manner that is as close to "natural" clinical language as feasible. This increases the possibility that safety signals will be picked up.
For a leading multinational pharmaceutical and biotechnology corporation producing the Coronavirus vaccine globally for ages 12+, Wipro ensured the required regulatory compliance and patient safety process for the vaccine.
The client’s challenge involved the backlog of Adverse Events and volume spikes that kept growing as more and more countries began approving their vaccine in a very short period. If unaddressed, this could have resulted in regulatory non-compliance. To tackle this situation, they needed expert healthcare professionals to manage their adverse event reporting. However, a distributed workforce during the pandemic posed a significant roadblock to sourcing and training resources quickly. In addition, the regulatory authorities were constantly releasing updates on conventions for performing case processing. Cases from different countries required in-depth understanding of different country level conventions, adding to the complexity of the process Keeping up with such a high frequency of updates and tracking digital acknowledgments and signoffs required immediate attention as the pandemic continued to ravage the world.
Fortunately, Wipro was ready with our decade plus years of experience for both swift sourcing and training of the right talent. Wipro ramped up hundreds of Health Care Professionals in just few months by deploying an extended panel of interviewers on a rotation basis to fulfill the huge sourcing ask. Wipro alone has processed over 0.7 M reports from 35 countries since December 2020.
How we see technology evolving over the next five years to strengthen patient safety
The life sciences sector is currently undergoing a transformation, with patient safety at the forefront. Automation, innovation, and advancements in digital health, AI, medical devices, and information technology (IT) are boosting collaboration and overall patient safety in both available treatments and those still in research and development (R&D).