Real-world evidence services

Overview

Today, the healthcare industry generates about 30% of the world's data.

However, the segregated data is of limited use. Regulatory agencies, such as the US Food and Drug Administration (FDA), the European Commission (EC), and the European Medicines Agency (EMA), are putting in place mechanisms to enhance data interoperability. The goal is to standardize datasets to help organizations collaborate to extract, analyze, and present valued evidence. Along with the health technology assessment (HTA), these agencies also use the data for drug development and emergency, reimbursement and pricing approvals, and marketing authorization.  

Real-world evidence (RWE) is the information derived from real-world data (RWD). Evidence from randomized clinical trials coupled with RWD obtained from electronic health records, patient registries, and smart health apps provide high-quality information. 

Patient input is integral for researchers and healthcare professionals (HCPs). Discovering their symptoms during any ailment enables effective treatment. TCS’ RWE services capture and incorporate patients' inputs throughout the clinical trials in a structured approach, presenting a 360-degree view of patients' health journeys and outcomes in real-world conditions. 

RWE adoption—by pharma companies, researchers, and healthcare professionals—faces numerous challenges. These include scalability, ambiguity in regulatory guidance, regional variations of real-world data accessibility, heterogeneity in RWD sources, adhering to data privacy laws, and using technology to translate these big data sets into meaningful evidence in real time.  

TCS brings together an experienced team of health economists, real-world data scientists, statisticians, and partners, along with integrated technology, standard and compliant processes, to help organizations comply with regulations and generate meaningful insights from available datasets. These aid in understanding drug safety and efficacy and navigate the regulatory approvals process.

Our solution

TCS’ offering helps pharma companies, researchers, and healthcare professionals leverage standardized, globally compliant real-world data.

Key features of the solution are: 

1. Real-world evidence study design and management
   • Study design: We engage with the key stakeholders in an advisory model to design a validated approach for generating decision-grade evidence for a specific research objective.
   • RWE study management: We execute RWE study conduct from protocol and statistical analysis plan to review database setup, data management, statistical analysis and programming, study report, and manuscript publication. We collaborate with third parties to optimize real-world data feeds and site environments.
   • RWE analytics: We generate meaningful insights applying our expertise in SAS (statistical analysis software), programming (R, Python), and relevant statistical analysis.
2. TCS’ HEOR (Health economics and outcomes research) services portfolio offers outcomes research, wherein we synthesize scientific outcomes employing an optimized delivery model for systematic literature reviews, meta-analysis, and network meta-analysis.
3. Our market access services enable life sciences companies with the following –
   • Value dossier development: We help create compelling value stories and develop global value dossiers (GVD) for American Managed Care Pharmacy (AMCP).
   • Advisory services: We utilize our best-in-class advisory model to engage with real-world evidence, health economics, outcomes research, and market access stakeholders. We deliver a long-term transformational roadmap by integrating business objectives with technology and process excellence.

Benefits

TCS’ Real-world evidence services provide evidence of safety and effectiveness in many regulatory decisions. 

We help life sciences and healthcare organizations:

• Support unmet evidence needs and synthesize decision-grade evidence with our comprehensive domain expertise and innovative solutions

• Ensure 30 – 40% cost savings with our right sourcing delivery model and a metrics-driven approach

• Save an additional 10 – 15% through process standardization, custom automation, and transformation 

• Ensure regulatory compliance with a scientific and unbiased rationale