Analyzing the Role of Pharmacovigilance Analytics in Germany’s Precision Medicine Market – A Case Study by Quantzig

Mar 10, 2020

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To succeed in today’s precision medicine market, one must overcome the challenges facing the sector by devising appropriate strategies to skilfully tackle unfavorable situations. However, with regulations continuing to emphasize patient safety, pharmacovigilance analytics will continue to play a pivotal role in the drug discovery & development phase.

Pharmacovigilance analytics broadly describes the process of leveraging advanced analytics to collect, analyze, and interpret complex datasets containing drug safety information to identify hidden patterns and unknown correlations that can help companies operating in the precision medicine market to make better decisions.

Considering the growing complexities around drug development and drug safety, pharmacovigilance departments within the precision medicine market must have in place a robust process to identify risks and extract product & indication-specific information from across the organization. However, keeping abreast of the regulatory changes and monitoring drug safety on an on-going basis can be challenging for companies, especially those who lack the expertise and necessary pharmacovigilance analytics tools to do so.

About the Client

The client is a leading player in the German precision medicine market, offering a diverse portfolio of products for both treatment and prevention of diseases, including prescription drugs, generics, and other solutions targeted at both the physician and individual consumer-level.

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The Business Challenge

With pain management and addiction drugs being new focus areas, the client decided to leverage pharmacovigilance analytics by partnering with Quantzig to build a robust pharmacovigilance analytics process. Using a pharmacovigilance analytics framework, the client wanted to analyze drug safety data obtained from various sources to build synergy between traditional analytics and clinical data to provide faster and better insights across the organization.

Additionally, the growing demand for their limited resources and lack of in-house pharmacovigilance and clinical data management systems prompted the pharma company to outsource their pharmacovigilance requirements. Also, the increased regulatory scrutiny and greater emphasis on drug safety within the precision medicine market in Germany, further pressurized the client to accurately monitor and assess the benefit-risk profile of the medicinal products as early as possible in the drug development lifecycle.

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Solution Offered

The pharmacovigilance analytics experts at Quantzig adopted a comprehensive three-phased approached that focused on expanding the drug development and safety monitoring initiative beyond case processing to include the data from aggregated precision medicine market reports.

Phase 1: Data Standardization and Compliance Monitoring

The first phase of this pharmacovigilance analytics engagement focused on data standardization and automation of the compliance monitoring processes. This was achieved through the integration of data using advanced analytics techniques and system interoperability standards, implementation of data management best practices, and technological concepts that revolved around analytics implementation.

Phase 2: Signal Detection and Risk Minimization

The second phase revolved around risk minimization to identify and predict emerging safety signals by implementing data mining techniques to bolster safety analytics, reporting, and investigation. The use of real-time dashboards further enhanced risk minimization by providing real-time drug safety summaries, improving awareness of risks across the portfolio, and timely execution of safety risk minimization activities. This step also helped the client to analyze the role of data mining in pharmacovigilance and make the most of the insights generated.

Phase 3: Benefit-Risk Identification and Analysis

In the final phase, advanced pharmacovigilance solutions were used to repeatedly extract, decode, and process drug safety data to offer real-time insights into safety issues. This not only provided more opportunities to enhance transparency with patients, regulators, and prescribers but also offered detailed insights into how precision medicine market players can use analytics to drive trust, collaboration and ultimately improve drug discovery and development processes.

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Value Delivered

The pharmacovigilance analytics solutions provided a new way to work with pharmacovigilance data, find insights, and drive operational efficiency within the precision medicine market.

Quantzig’s pharmacovigilance analytics solutions also empowered the client to:

  • Reduce preparation time for drug safety reviews from days to hours
  • Understand safety risks earlier in the drug development phase
  • Maintain good relationships with regulators
  • Enhance the protection of patients

Quantzig’s pharmacovigilance analytics solutions have helped leading pharmaceutical, biotech, and life sciences companies worldwide. The solution empowers the broadest spectrum of pharmacovigilance, clinical, and other data management teams within the precision medicine market to easily access and analyze clinical data, identify trends representing risks and opportunities, and empowers them to dig deeper into the data without relying on biostatistics and support from IT teams. This allows companies operating in the precision medicine market to quickly review clinical data and develop targeted drugs by leveraging an improved drug development and safety monitoring process

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