How FDA Real-World Evidence Analytics Helped to Understand the Drug Effects for a Pharmaceutical Company?

Jul 27, 2022

Highlights of the Case Study: 

Particulars Description 
Client A renowned pharmaceutical company sought to produce real-world evidence (RWE) to track and assess drug products. 
Business Challenge The client examined multiple data sources to analyze the applications of drugs and biologics and assess safety concerns. More importantly, our client wanted to test the effects of FDA-approved interventions on specific patient populations, particularly those with unmet medical requirements. 
Impact Quantzig helped the client with real-world evidence analytics solutions that allowed the pharmaceutical client to manage its constantly evolving patient data. 

Game-Changing Solutions for the Pharmaceutical Industry 

Real-world data (RWD) and real-world evidence (RWE) play a critical role in drug development and making mission-critical regulatory decisions. Drug Regulatory Authorities (DRA) leverage RWE to assess the therapeutic approaches of various manufacturers and keep track of post-market safety. Pharma companies can further augment RWE using data analytics to provide clinical evidence on a particular medical therapy’s potential benefits and hazards. The inability of RWE to demonstrate the efficacy of treatment at a level comparable to randomized controlled trials (RCTs) poses significant difficulties.    

Quantzig’s real-world evidence analytic solutions determine a disease’s progression, a patient’s response to medicine, and the probability of occurrence of health events. These solutions can effectively assess patient traits and behaviors that impact patient health. Additionally, advanced RWE analytics utilizes predictive models, machine learning, causal models, and unsupervised algorithms to extract deeper insights from large data sets. Pharma companies can use thousands of patient characteristics to understand clinical factors affecting trial outcomes and gain insights into drug performance and differentiation. Companies can also run precise scenarios with predictive models and generate hypotheses at scale for various therapies, comparisons, and endpoints.   

The Challenges of the Client 

Quantzig collaborated with a renowned pharmaceutical company to produce RWE to track and assess drug products. The client examined multiple data sources to analyze the applications of drugs and biologics and assess safety concerns. More importantly, our client wanted to test the effects of FDA-approved interventions on specific patient populations, particularly those with unmet medical requirements. The client intended to identify best practices for both current and novel therapies through this method and sought to address the following issues.    

  • Potentially inappropriate medications (PIMs)   
  • Unstructured data    
  • Inability to distinguish between lower and higher quality RWE    
  • Lack of apparent regulatory system for RWE-based methods   
  • Skepticism about findings obtained outside of conventional randomized controlled trials (RCTs)   
  • Inadequate knowledge of non-interventional research techniques   

The client approached Quantzig to explore real-world evidence analytics solutions that gathered evidence from real-world data. This real-world evidence sheds light on the pros and cons of a drug, which is essential to understanding patient outcomes and ensuring successful treatment. The client also planned to develop a new platform to enable users to assess the effectiveness of novel pharmacological treatments or other products using real-world data.   

Quantzig’s Real-World Evidence Analytic Solutions  

Quantzig offered RWE-based analytics solutions that helped the pharmaceutical client to manage its constantly evolving patient data. The solution also provided the client with knowledge about the product’s advantages, simplifying inclusion in the reimbursement policy. Quantzig’s RWE delivers clinical data on the progress of trials daily. Additionally, Quantzig’s software included a variety of capabilities that would aid clients in analyzing and comprehending various patient data, patterns of disease progression, and populations to provide in-depth clinical insights. Additionally, the FDA monitors post-market safety and adverse health events using real-world data and RWE.   

Our analytics system analyzed and predicted the following attributes:   

  • Generate insights on treatments performed among specific patient sub-groups   
  • Analyze the effectiveness of medication therapies and other interventions while considering additional elements and variables   
  • Provide insightful data on a range of subjects, including the natural history of an illness, the most recent treatment plan, and the status of existing service structures   
  • Develop theories for upcoming trials   
  • Monitor safety, particularly for unusual or infrequent adverse responses   

FDA REAL-WORLD Analytics Solution
  • Generate insights on treatments of specific patient sub-groups 100% 100%
  • Measure effectiveness of medication therapies 100% 100%
  • Provide insightful data on a range of subjects 100% 100%
  • Develop theories for upcoming trials 100% 100%
  • Monitor unusual or infrequent adverse responses 100% 100%

Impact Analysis of Quantzig’s RWE Analytics Solutions 

Our real-world evidence analytic solutions helped our client achieve the following benefits:  

  • Reduced costs and time of clinical trials   
  • Precise conclusion about medications   
  • Increase ROI for pharma businesses    
  • Offer comprehensive insights about the course of treatment and its results.   
  • Facilitate scientific collaboration with essential stakeholders and experts   
  • Extrapolate results from a more extensive dataset   


The pharmaceutical client created a robust platform using real-world evidence insights, which helped it achieve a competitive edge in the performance of the products. It also gathered enormous amounts of information from a diverse patient population, making it feasible for the client to determine the efficacy of drugs or products using RWE. Using this data, the client could evaluate the performance of drugs outside the purview of clinical trials. Additionally, RWE analytics assisted the client in interpreting information from clinical trials, drug usage trends, and patient treatment outcomes. Analyzing and evaluating such data was impossible for the client, but the RWE analytics solution made the data management process efficient, seamless, and transparent.   

Key Outcomes 

The overall result of Quantzig’s RWE analytics solution was that it enabled the pharmaceutical client to manage and evaluate its products in terms of efficacy and suitability across different patient populations. The solutions thus facilitated a better understanding of the medicines, which would lead to the development of new and supplementary products. Our analytics solution also helped the client collaborate with stakeholders and experts in the industry and leverage results from a larger dataset.    

Broad Perspective on RWE Analytics Solutions for Pharmaceuticals Business 

Pharmaceutical companies can effectively understand patient journeys and market dynamics by methodically linking various datasets. Companies can create new marketing and sales strategies by focusing on the patient journey and developing a deeper awareness of latent sales potential. Data analytics also improves physician-patient segmentation, targeting, tactics, and promotional spending using patient-centered analytics with RWE. As a result, their detailing efficacy has grown by 15%, and their promotional effectiveness has increased significantly.   

Key Takeaways 

The use of RWE Analytics Solutions:  

  • Help expedite clinical trials and reduce costs  
  • Enable precise, data-based evaluation of drugs and medicines  
  • Facilitate new product development based on critical findings on drug efficacy across diverse patient pools 
  • Improve ROI for pharmaceutical companies 
  • Enhance interaction among stakeholders within the pharmaceutical industry

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