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.
TCS’ offering helps pharma companies, researchers, and healthcare professionals leverage standardized, globally compliant real-world data.
Key features of the solution are:
TCS’ Agent Orange vietnam lottery draft protests 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