Article
How automation increases efficiency and accuracy of local PV monitoring and KPI tracking
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Iain Barnden
In today’s data-intensive and complex global pharmacovigilance landscape, monitoring multi-country local affiliate pharmacovigilance (PV) activity is posing an increasing challenge –and major resource burden – for biopharmaceutical companies. Country-specific regulations are diverse and evolving, and local PV systems and requirements are similarly varied and dynamic. For this reason, safety managers today often view harmonizing practices while allowing for local complexities as a top concern.
Challenges in managing local PV activities
Intensifying regulatory oversight of local pharmacovigilance is leading to more demanding audits. In tandem, biopharmaceutical companies are requiring tighter Service Level Agreement (SLA) adherence from outsourced service providers. However, stringent monitoring of local PV compliance – both at the compliance and operational level – is highly resource-intensive, and specialized expertise and experience is typically required to effectively oversee local activities. From local literature screening and PV intelligence to local Individual Case Safety Report (ICSR) management and submissions, the need to efficiently and accurately track and report on all local PV activities is therefore a common and pressing concern for businesses marketing products internationally.
Given these pressures, the opportunity to introduce a greater level of automation into high-touch and overhead-heavy local pharmacovigilance tracking activities is compelling. Increasing the efficiency of collecting key metrics, monitoring Key Performance Indicators (KPIs) and tracking SLAs offers myriad benefits for biopharmaceutical companies – most prominently the ability to reduce internal workloads and costs while boosting oversight and control.
Strategic benefits of automation
For busy safety teams, minimizing the manual tracking component of managing local PV activities can significantly improve data quality and consistency which, in turn, enhances overall audit-readiness and compliance. Implementing secure global systems and processes can usher in a new level of centralized coordination, coupled with the country-specific adaptability and agility needed for optimal management across geographies.
Crucially, the benefits of automation are not simply tactical but strategic. Streamlined technology solutions for managing local PV activities allow instant data and quality checking, improving visibility of compliance benchmarks and offering valuable trend insights to inform resource-planning and management decision-making. Freeing safety teams from burdensome manual effort allows a much-needed refocus on business-critical safety strategies and value-added activities, plus further aligns companies with the industry shift towards patient-centric PV and a proactive approach to meeting regulatory obligations.
Crucially, the benefits of automation are not simply tactical but strategic. Streamlined technology solutions for managing local PV activities allow instant data and quality checking, improving visibility of compliance benchmarks and offering valuable trend insights to inform resource-planning and management decision-making. Freeing safety teams from burdensome manual effort allows a much-needed refocus on business-critical safety strategies and value-added activities, plus further aligns companies with the industry shift towards patient-centric PV and a proactive approach to meeting regulatory obligations.
Proven impact:
Digital innovation in local PV management
For tech-forward organizations, the results that can be achieved through local PV management automation are striking. For example, we worked with one global biopharmaceutical company to implement fully validated tracking and reporting system harmonized with delivery of local pharmacovigilance services. The project scope was extensive – encompassing more than ninety countries and supported by over 150 of our subject matter experts in-country or in hub locations.
The outcomes for the customer were compelling. They can now conduct consolidated and comprehensive tracking for all local PV activities, configurable to their evolving business requirements as well as constantly evolving local safety obligations. Multiple KPIs can be measured over any time period, available globally, by region or by country. The customer is now successfully improving tracking consistency and coordination for regional programs, which span hundreds of ICSRs and thousands of literature and PV intelligence screenings per year for more than 850 products in multiple therapeutic areas.
The outcomes for the customer were compelling. They can now conduct consolidated and comprehensive tracking for all local PV activities, configurable to their evolving business requirements as well as constantly evolving local safety obligations. Multiple KPIs can be measured over any time period, available globally, by region or by country. The customer is now successfully improving tracking consistency and coordination for regional programs, which span hundreds of ICSRs and thousands of literature and PV intelligence screenings per year for more than 850 products in multiple therapeutic areas.
Business-driven innovation by pharmacovigilance experts
Results like these are not an accident, but are produced by a thoughtful approach to digital innovation around four core principles:
By combining deep safety expertise with innovation encompassing proven and emerging digital technologies, companies can obtain the right balance of pragmatic innovation with measurable outcomes. Key examples of this methodology at work for local PV operations include:
With confidentiality and data protection assured through access on a per-role and per-country basis, the safety team can automatically aggregate and calculate KPI data and SLA metrics – eliminating for the need for manual tracking and maintaining complex spreadsheets and consolidation formulas.
Automated trackers are instantly available for ICSR activity, literature surveillance and PV intelligence, supported by volumetric reporting viewable by time period and country, headline metrics, counts over time, projections and top ‘n’. This holistic tracking enables the activation of new features such as automated invoice creation, trend analysis and capacity planning plus advanced customer reporting.
For quality reporting, the customer can now also configure processing SLAs (for example, reporting ICSRs to the customer in a set number of days) and highlight key areas of concerns on a country basis, including ICSR submission delays and performance trends over time.
To facilitate KPI tracking, the company has gained a clear and consistent overview of the crucial metrics per activity – such as the time taken to report ICSRs to the Marketing Authorization Holder; when PV Intelligence results and impact assessments have been sent; and whether local literature has been screened on time. KPIs can be easily analyzed per country, and compliance reports for each activity can be readily generated on a per country basis for management review.
A further, crucial capability for the customer’s safety teams is the ability to easily extract custom tracking reports for cross-checking and reconciliation with internal safety databases.
- Discussions about digital innovation are often driven by hype – but hype is not a strategy
- Digital innovation is not about technology, it’s a human-focused transformation process
- The desired outcome should drive innovation – not the other way around
- Successful outcomes require broad and deep understanding of your business
By combining deep safety expertise with innovation encompassing proven and emerging digital technologies, companies can obtain the right balance of pragmatic innovation with measurable outcomes. Key examples of this methodology at work for local PV operations include:
With confidentiality and data protection assured through access on a per-role and per-country basis, the safety team can automatically aggregate and calculate KPI data and SLA metrics – eliminating for the need for manual tracking and maintaining complex spreadsheets and consolidation formulas.
Automated trackers are instantly available for ICSR activity, literature surveillance and PV intelligence, supported by volumetric reporting viewable by time period and country, headline metrics, counts over time, projections and top ‘n’. This holistic tracking enables the activation of new features such as automated invoice creation, trend analysis and capacity planning plus advanced customer reporting.
For quality reporting, the customer can now also configure processing SLAs (for example, reporting ICSRs to the customer in a set number of days) and highlight key areas of concerns on a country basis, including ICSR submission delays and performance trends over time.
To facilitate KPI tracking, the company has gained a clear and consistent overview of the crucial metrics per activity – such as the time taken to report ICSRs to the Marketing Authorization Holder; when PV Intelligence results and impact assessments have been sent; and whether local literature has been screened on time. KPIs can be easily analyzed per country, and compliance reports for each activity can be readily generated on a per country basis for management review.
A further, crucial capability for the customer’s safety teams is the ability to easily extract custom tracking reports for cross-checking and reconciliation with internal safety databases.
Summary
While close monitoring of local pharmacovigilance activities is essential for compliance in today’s complex and diverse regulatory environment, it demands significant resources that are increasingly unsustainable – and unscalable – for many biopharmaceutical businesses. To address this growing challenge, organizations are turning to tech-forward outsourcing partners and validated tracking systems that can streamline operations.
By delivering centralized coordination and visibility, with full flexibility for specific local needs, automated solutions are proving to be effective for improving efficiency and accuracy of PV operations.
By delivering centralized coordination and visibility, with full flexibility for specific local needs, automated solutions are proving to be effective for improving efficiency and accuracy of PV operations.
About the author:
Iain Barnden is PV Business Partner and Digital Innovation Director at Cencora, with more than 20 years of experience in pharmacovigilance and advanced technologies.
Disclaimer:
The information provided in this article does not constitute legal advice. Cencora, Inc., strongly encourages readers to review available information related to the topics discussed and to rely on their own experience and expertise in making decisions related thereto.
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