Industry
Life Sciences
Patient-centered Care Models Taking Center Stage in Life Sciences
Highlights
- Although the healthcare industry generates around 30% of the world's data, the segregated data is of limited use.
- Regulatory agencies are working toward enhancing interoperability and standardizing datasets for organizations to collaborate and analyze this data.
- Real-world evidence (RWE)—the information derived from real-world data (RWD)—is of immense value. In 2020, this formed the basis of approvals for drug development for 75% of contagious diseases cases and 90% of oncology cases.
- TCS applies its extensive domain expertise and brings together the healthcare ecosystem to boost RWE adoption.
- Our solutions facilitate real-world evidence study design and management and enable life sciences companies with health economics and outcomes research (HEOR) and market access service portfolios.
In this article
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:
- 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.
- 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.
- 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
The TCS advantage
TCS anchors transformative process excellence-driven RWE engagements for the global life sciences and healthcare community.
TCS offers the following unique advantages:
- Full-service portfolio and a global reach: We have over 50 years of experience creating value for our customers globally. Our best-in-class capabilities help organizations unlock new growth opportunities.
- Expertise in life sciences clinical services: We have more than 7,000 associates dedicated to delivering value and transformation in clinical services worldwide for our life sciences clients. Over 35% of our clinical services associates are PhDs or have a master’s degree in medicine, pharmacy, and life sciences. We benefit from and integrate good clinical practice (GCP) with emerging best practices in regulatory-grade real-world evidence.
- Deep domain knowledge: We have deep domain knowledge, technological expertise, and business process experience of working with the top 15 across pharma companies, the top nine in MedTech, top five in clinical labs, the top six in health payers, the top four in hospital networks, the top three in retail pharmacy chain, and one of the leading third-party administrators (TPAs). This unique experience helps to create and navigate real-world data-synthesizing communities seamlessly.