Modern technology solutions for Pharmacovigilance are required to solve the emerging needs in the area
Global health trends indicate a greater need for patient-centric strategies that involve patients at all levels throughout the healthcare continuum. Currently, health risks to patients are evolving due to changing nature of diseases, increasing complexity in product portfolios and therapeutic areas (ICSR volumes are increasing year over year). Keeping up with these global health trends requires proactive monitoring.
Regulatory bodies are responding to these changes
Regulatory agencies around the globe are closely scrutinizing products before they are introduced to the market. As regulations evolve, they implement processes and standards to discuss real-world evidence for product safety. With this, new PV capabilities with appropriate technology have become the need of the hour.
PV to become more efficient to drive value from big data
Pharmaceutical companies that are aiming to register their products must develop robust PV capabilities in order to fulfil PV obligations, despite rising pressure to reduce/minimize costs. With new sources of information – wearables, social media, claims data, and EHRs – PV must become more efficient to drive value out of endless amounts of data to transform pharmacovigilance into a learning system to improve a drug’s risk-benefit profile.
With growing complexity of the PV landscape, there is a need for new methods to communicate safety signals, learn from them, and understand their impact on the drugs market.
The main PV challenges for the next 5 years will be:
• The complexity of the PV system will only grow with the number of drugs and new drugs entering the market.
• The challenge will be to create a learning system that can learn from signals, make decisions, and improve the safety profile of drugs.
• With the new sources of information, PV will transform into a science of learning and data analytic
Global pharma and CRO’s are looking for modern PV solutions that can help them face these rising challenges.
At Datafoundry, we understand the importance of having a modern pharmacovigilance system that can accommodate the changing world of life sciences.
Modern pharmacovigilance is an umbrella term which includes the following three sub-areas:
a. Adverse event reporting
b. Safety monitoring
c. Reporting and analysis of post-marketing data.
We built an integrated solution that brings all these three together powered by the latest tech stack with advanced machine learning and deep learning capabilities that enable pharma companies and CROs (Contract Research Organizations) overcome the challenges they face with legacy PV systems. We brought together multiple AI/ML technologies such as NLP, OCR and NER to build a comprehensive safety system that ensures more gets done with least human intervention.