Real World Evidence Solutions for Pharma & Biotech

Real World Evidence Market size

The healthcare and pharmaceutical landscape is changing at an unprecedented pace. Traditional randomized controlled trials (RCTs), while the gold standard, are not always enough to answer today’s complex clinical questions. This is where real world evidence (RWE), generated from real world data (RWD) such as patient registries, electronic health records (EHRs), claims data, and wearable devices, steps in as a transformative force.

The market for real world evidence solutions itself is expanding rapidly. According to a recent analysis by Data Insights Market (2025), the sector is projected to surpass USD 1 billion in value by 2025 and sustain a 12% compound annual growth rate (CAGR) through 2033. This growth is being driven by the adoption of digital health technologies, regulatory acceptance of RWE for approvals and surveillance, and the urgent need for cost-effective healthcare solutions amid rising chronic disease prevalence.

Against this backdrop, pharma companies need robust real world evidence strategies that deliver regulatory grade, actionable insights. At Navitas Life Sciences, we combine deep scientific expertise, global regulatory experience, and advanced data analytics to help sponsors turn real world data into meaningful evidence that informs decisions across the product lifecycle.

The Growing Role of Real World Evidence in FDA Decisions

The FDA’s real world evidence framework has accelerated the acceptance of RWE in drug development and regulatory submissions. In guidance documents and pilot programs, the agency has emphasized how well-designed RWE studies can complement clinical trial findings, support label expansions, and strengthen post-marketing safety monitoring.

This shift represents a significant opportunity for real world evidence companies, but it also raises the stakes: regulators expect high-quality data, carefully chosen methodologies, and transparent reporting.

Navitas Life Sciences works closely with sponsors to ensure that their real world evidence strategy is aligned with regulatory expectations. Our consulting teams bring hands-on knowledge of FDA, EMA, and other global authority requirements, helping companies build defensible evidence packages that accelerate approval and market access.

Why Patient Registries Are the Cornerstone of RWE

One of the most powerful tools in generating RWE is the patient registry. Registries provide longitudinal data that capture disease progression, treatment patterns, and real-world outcomes. They are particularly vital in rare diseases, where small patient populations and limited clinical trial data make post-marketing evidence essential.

At Navitas Life Sciences, we design and manage patient registries that go beyond data collection. Our approach ensures:

• Rigorous governance and compliance standards
• Standardized data models and interoperability
• Engagement with patients, investigators, and advocacy groups
• Analytics-driven insights that inform clinical, regulatory, and market strategies

By combining scientific rigor with patient-centered design, our registries deliver evidence that is credible to regulators, actionable for sponsors, and meaningful to patients.

This holistic approach positions Navitas Life Sciences as a strategic partner for pharma and biotech companies seeking high-quality real world evidence.

Partnering for Real World Evidence Success

Real world evidence solutions are a strategic asset that can redefine drug development and commercialization.

By partnering with Navitas Life Sciences, sponsors gain access to:

• Trusted expertise and global regulatory networks
• Innovative analytics and AI/ML-driven modeling
• Patient registries designed for compliance and impact

Whether designing a registry, preparing a submission, or building a long-term RWE strategy, Navitas Life Sciences ensures success at every stage.

Learn more about our services and solutions by reaching out to us at This email address is being protected from spambots. You need JavaScript enabled to view it..