Prioritizing Safety and Pharmacovigilance in the Age of Innovation
Apr 22, 2024 |
Sumi Kim, Director, Asia Clinical Operations and Safety Strategy
Over the years, the life sciences industry has evolved rapidly, as a result of massive advancements in the understanding of various disease areas, and a relentless focus on innovation. With significant developments in the space, the life sciences industry’s approach to pharmacovigilance has also shifted in tandem.
A robust pharmacovigilance and safety strategy is crucial, regardless of a company’s scale. There are a number of safety challenges and considerations facing biotech and life sciences companies as they scale up, as well as larger pharmaceutical companies who outsource pharmacovigilance to external partners, which could result in reduced accountability and granularity when it comes to managing safety issues.
Solutions like Veeva Vault Safety enable life sciences companies to bring management of safety processes in-house, with global end-to-end adverse event management on a unified platform, enabling access to real-time information.
Changes in the pharmacovigilance landscape
Pharmacovigilance has traditionally been focused on reporting safety data and adverse events to relevant authorities. However, safety in the life sciences has always been a continuous and dynamic space, especially as the industry adapts to demand and changing norms. As more innovative therapies, drugs and products come to the fore, pharmacovigilance should also evolve to meet the needs of accelerated pathway approvals.
Over the years, there has been significant shifts in the approach to pharmacovigilance – from using siloed data to encouraging secure collaboration. Secure collaboration is now a foundational aspect of pharmacovigilance today, as the advent of cloud computing has fuelled shifts to more de-siloed ways of working. Safe data sharing, real-time analysis, and scalable resources have all played a critical role in fostering a more efficient and data-driven approach to drug safety.
At Veeva, we see a growing trend of customers in Asia prioritizing collaboration internally and with relevant external vendors, and applying it holistically to their business processes. There has been a fundamental shift to the safety strategy in the industry, with more companies making the switch to in-house R&D, as is the case for many biopharmas in Korea. This has posed a challenge for well-established pharmacovigilance processes, which were well suited to more generic development and production.
Companies now have to navigate a landscape with a greater number of diverse stakeholders, which has rendered fragmented pharmacovigilance processes obsolete due to difficulties in coordinating internal and external stakeholders in the safety process. A fast-paced industry has necessitated greater collaboration and more streamlined, standardized reporting procedures. By creating shared data repositories, or even dedicated teams, a more collaborative approach can create clearer pharmacovigilance processes, improving data quality and ultimately enhancing patient safety. In parallel, we’ve also witnessed a growing demand for solutions that can support these new ways of working, as the industry continues to evolve.
What does a good pharmacovigilance strategy look like
Pharmacovigilance often involves cross-functional teams working together, which includes Regulatory, Clinical, and Medical Affairs. Having a platform that eliminates data silos, and streamlines communications between teams to enable a more efficient and collaborative safety process, is key in a good pharmacovigilance strategy.
Life sciences companies can also leverage cloud-based technology, to foster a single source of truth for safety data, ensuring everyone has access to the most current and accurate information. Cloud-based systems are designed for continuous updates and innovation, allowing the safety strategy to adapt to evolving regulations and scientific advancements. Finally, the efficiency gains from cloud technology free up valuable resources for in-depth safety analysis and proactive risk management.
As the life sciences industry undergoes rapid transformation, traditional pharmacovigilance methods, with outdated processes and ways of working, will soon struggle to keep pace. By prioritizing secure collaboration, leveraging cloud-based technology, and adopting data-driven approaches, companies can develop a more robust and adaptable pharmacovigilance strategy. This shift is crucial not only for ensuring regulatory compliance but also fostering continued innovation in the development of life-saving therapies.
What Vault Safety offers
Companies that employ Vault Safety can access and monitor safety cases anytime, ensuring compliance and avoiding delays from data transfer requests. An easy-to-use system like Veeva Vault Safety further streamlines collaboration with CROs while keeping control in-house.
Beyond offering a unified safety approach and real-time data access, Vault Safety shines in its ever-evolving capabilities, particularly its focus on seamless connections between various Veeva Vault applications.
As life sciences companies in Asia expand globally, their safety databases require re-configuration as they grow rapidly. Cloud-based solutions like Vault Safety can help, as the platform allows teams across borders and partners and CROs to work together seamlessly, sharing data and collaborating in real-time. Furthermore, Vault Safety is adaptable to each company’s needs, growing with them and complying with local regulations. It is a one-stop shop for ensuring patient safety in a region with varying needs.
Learn more about Vault Safety here.
A robust pharmacovigilance and safety strategy is crucial, regardless of a company’s scale. There are a number of safety challenges and considerations facing biotech and life sciences companies as they scale up, as well as larger pharmaceutical companies who outsource pharmacovigilance to external partners, which could result in reduced accountability and granularity when it comes to managing safety issues.
Solutions like Veeva Vault Safety enable life sciences companies to bring management of safety processes in-house, with global end-to-end adverse event management on a unified platform, enabling access to real-time information.
Changes in the pharmacovigilance landscape
Pharmacovigilance has traditionally been focused on reporting safety data and adverse events to relevant authorities. However, safety in the life sciences has always been a continuous and dynamic space, especially as the industry adapts to demand and changing norms. As more innovative therapies, drugs and products come to the fore, pharmacovigilance should also evolve to meet the needs of accelerated pathway approvals.
Over the years, there has been significant shifts in the approach to pharmacovigilance – from using siloed data to encouraging secure collaboration. Secure collaboration is now a foundational aspect of pharmacovigilance today, as the advent of cloud computing has fuelled shifts to more de-siloed ways of working. Safe data sharing, real-time analysis, and scalable resources have all played a critical role in fostering a more efficient and data-driven approach to drug safety.
At Veeva, we see a growing trend of customers in Asia prioritizing collaboration internally and with relevant external vendors, and applying it holistically to their business processes. There has been a fundamental shift to the safety strategy in the industry, with more companies making the switch to in-house R&D, as is the case for many biopharmas in Korea. This has posed a challenge for well-established pharmacovigilance processes, which were well suited to more generic development and production.
Companies now have to navigate a landscape with a greater number of diverse stakeholders, which has rendered fragmented pharmacovigilance processes obsolete due to difficulties in coordinating internal and external stakeholders in the safety process. A fast-paced industry has necessitated greater collaboration and more streamlined, standardized reporting procedures. By creating shared data repositories, or even dedicated teams, a more collaborative approach can create clearer pharmacovigilance processes, improving data quality and ultimately enhancing patient safety. In parallel, we’ve also witnessed a growing demand for solutions that can support these new ways of working, as the industry continues to evolve.
What does a good pharmacovigilance strategy look like
Pharmacovigilance often involves cross-functional teams working together, which includes Regulatory, Clinical, and Medical Affairs. Having a platform that eliminates data silos, and streamlines communications between teams to enable a more efficient and collaborative safety process, is key in a good pharmacovigilance strategy.
Life sciences companies can also leverage cloud-based technology, to foster a single source of truth for safety data, ensuring everyone has access to the most current and accurate information. Cloud-based systems are designed for continuous updates and innovation, allowing the safety strategy to adapt to evolving regulations and scientific advancements. Finally, the efficiency gains from cloud technology free up valuable resources for in-depth safety analysis and proactive risk management.
As the life sciences industry undergoes rapid transformation, traditional pharmacovigilance methods, with outdated processes and ways of working, will soon struggle to keep pace. By prioritizing secure collaboration, leveraging cloud-based technology, and adopting data-driven approaches, companies can develop a more robust and adaptable pharmacovigilance strategy. This shift is crucial not only for ensuring regulatory compliance but also fostering continued innovation in the development of life-saving therapies.
What Vault Safety offers
Companies that employ Vault Safety can access and monitor safety cases anytime, ensuring compliance and avoiding delays from data transfer requests. An easy-to-use system like Veeva Vault Safety further streamlines collaboration with CROs while keeping control in-house.
Beyond offering a unified safety approach and real-time data access, Vault Safety shines in its ever-evolving capabilities, particularly its focus on seamless connections between various Veeva Vault applications.
As life sciences companies in Asia expand globally, their safety databases require re-configuration as they grow rapidly. Cloud-based solutions like Vault Safety can help, as the platform allows teams across borders and partners and CROs to work together seamlessly, sharing data and collaborating in real-time. Furthermore, Vault Safety is adaptable to each company’s needs, growing with them and complying with local regulations. It is a one-stop shop for ensuring patient safety in a region with varying needs.
Learn more about Vault Safety here.