Real world Evidence Solutions for Foundations

Real-world evidence (RWE) is emerging as a cornerstone of modern clinical development and regulatory strategy for patient-centric innovation.

How is real-world evidence transforming clinical trials in Asia-Pacific?

In her latest article published in PharmaFocus Asia, Yun Lu, Chief Science and Innovation Officer at Navitas Life Sciences, explores this transformation and its growing momentum across the Asia-Pacific region. Titled “From Real World to Real Impact: Transforming Trials in the Era of RWE in Asia-Pacific,” the article highlights how evolving regulatory acceptance, increasing digitization of healthcare, and access to diverse patient populations are positioning the region as a global leader in RWE adoption.

The article highlights that RWE it is becoming central to how organizations generate evidence, support regulatory submissions and demonstrate real-world value. This naturally leads to another critical question: “What role does real-world evidence play in regulatory approvals and market access?”

Across Asia-Pacific, regulators are increasingly recognizing the importance of real-world data (RWD) in supporting label expansions, post-marketing commitments and long-term safety monitoring. At the same time, innovations in data capture, from electronic health records to genomics and wearable devices, are enabling continuous and more patient-centric insights.

Building a Future-Ready RWE Strategy

How can we design and implement an effective real-world evidence strategy?

Successful RWE initiatives require a seamless integration of strategy, operations, data and technology. Our approach is designed to help organizations move from fragmented datasets to decision-grade evidence that can drive both clinical and commercial outcomes.

We support end-to-end RWE lifecycle management, from study design and protocol development to data harmonization, analytics and regulatory alignment. By combining deep therapeutic expertise with advanced data capabilities, we enable organizations to generate evidence that is not only scientifically robust but also aligned with global and regional regulatory expectations.

What are the benefits of real-world evidence in clinical development and outcomes research?

The answer lies in RWE’s ability to complement clinical trials, reduce uncertainty and provide insights into how therapies perform in real-world settings across diverse populations.

Patient Registries: The Backbone of Real-World Evidence

A critical enabler of high-quality RWE is the development and management of patient registries, which provide longitudinal, real-world insights into disease progression and treatment patterns.

What are the best practices for setting up patient registries in healthcare and pharma?

Registries are strategic assets that support research, regulatory decision-making and clinical practice. They enable long-term tracking of patient outcomes, support post-marketing surveillance and create opportunities for stakeholder collaboration.

Designing scalable registries requires careful planning. Organizations must define clear research objectives, identify target patient populations, establish governance frameworks and ensure interoperability across data systems. Long-term sustainability, regulatory compliance and stakeholder engagement are equally critical to success.

Proven Execution: Advancing Genetic Research Through Registry Excellence

Navitas Life Sciences’ expertise in registry operations and data coordination is exemplified through its support for the Parkinson’s Foundation’s PD GENEration Registry—a large-scale genetic registry program aimed at advancing research and improving care for people living with Parkinson’s disease.

The Parkinson’s Foundation is committed to accelerating research and improving outcomes for individuals with Parkinson’s disease (PD) and those at risk. Through its Global Care Network, the Foundation enables genetic testing and builds a robust repository of genetic and clinical data to support ongoing research efforts. As part of this initiative, the Foundation required an experienced partner to serve as the Registry Coordinating Center for the PD GENEration program.

What does it take to successfully manage a large-scale genetic registry program while ensuring data quality, regulatory compliance and seamless site coordination?

Navitas Life Sciences was selected to provide comprehensive support across registry operations, regulatory oversight, data management, data insights, and eSolution enablement. A key priority was to develop a user-friendly registry system that ensured efficient data capture while minimizing burden on participating sites. At the same time, Navitas supported submissions to local and central ethics committees, enabled ongoing communication with sites regarding participant progress, and tracked site-level metrics to identify performance gaps and share best practices.

A central component of this engagement was the ability to support data harmonization and interoperability across multiple systems and data sources. Navitas ensured that data from clinical sites, genetic testing laboratories, and counseling centers could be integrated effectively, enabling a unified and usable dataset for researchers and stakeholders. This also supported broader collaboration, including data sharing with the Parkinson’s Foundation’s partners and the wider Parkinson’s research community.

Leveraging its deep experience in registry operations and technology enablement, Navitas implemented a full-service coordinating center model. This included operational and regulatory support, site management, monitoring, and advanced data management capabilities. Tailored solutions were designed to meet the unique needs of the program, ensuring flexibility while maintaining consistency and quality.

The impact of this approach is reflected in the scale and effectiveness of execution. Navitas supported the management of 110 sites, including super sites, local sites, and referral sites, while also working toward expanding the registry to additional domestic and international locations. The team conducted site initiation visits, supported ethics and regulatory submissions, and provided training on protocol procedures and data entry.

To enhance system performance and interoperability, Navitas developed APIs that enabled seamless integration across multiple registry and genetic databases. In a notable example of agility, the team also developed a temporary REDCap system within two weeks to support the Foundation and participating sites.

From a data perspective, Navitas ensured balanced, efficient, and risk-based data management processes, including hierarchical data quality review. The team successfully integrated clinical data from nearly 2,000 patients across multiple sources—each with different data definitions—with genetic data from laboratories and counseling centers.

This effort enabled the generation of high-quality datasets that were shared with leading research initiatives, including The Global Parkinson’s Genetics Program (GP2) and The National Institute on Aging (NIA).

The results demonstrate not only operational excellence but also meaningful scientific contribution. Navitas streamlined processes across more than 90 sites, ensured efficient data management and quality control and enabled successful integration of clinical and genetic data at scale.

This ongoing collaboration reinforces Navitas Life Sciences’ position as a trusted partner in delivering complex registry programs and data coordinating center support, helping organizations transform real-world data into actionable insights that advance research and improve patient outcomes.

Advancing Registries for Long-Term Impact

Beyond individual programs, Navitas brings a structured and scalable approach to registry design and execution. This includes integrated clinical research capabilities, robust data infrastructure, and centralized coordination models that ensure consistency and quality across global sites.

What does it take to build a sustainable, scalable patient registry?

The answer lies in a combination of scientific, operational and technological capabilities. From protocol development and data model design to compliance oversight and risk-based monitoring, every component must be aligned to ensure long-term success.

Navitas supports registry programs with secure technology platforms, real-time dashboards, and advanced analytics capabilities powered by AI and machine learning. At the same time, our site engagement strategies, including patient tracking, multilingual support and referral networks, ensure strong participation and data completeness.

Enabling Foundations Through Data-Driven Innovation

Navitas also works closely with foundations and nonprofit organizations, particularly in the rare disease space, where registries play a critical role in advancing research and improving patient outcomes.

How can foundations use real-world data for rare disease research and patient impact?

Our work with large-scale registry programs, including support for global initiatives like Parkinson’s disease registries, demonstrates our ability to integrate clinical and genetic data, enable data sharing with global research programs and generate meaningful insights that support scientific discovery.

By combining operational excellence with advanced data capabilities, Navitas empowers foundations to transform data into evidence that can influence research and patient care.

30 Minutes with an Expert: Take the Next Step

As RWE continues to reshape the life sciences landscape, organizations are increasingly seeking expert guidance to navigate complexity and unlock value.

If you are asking:
“What are the key steps to building a successful RWE program?”
or
“How can we leverage real-world data to improve clinical and commercial outcomes?”
We invite you to take the next step.

Navitas Life Sciences is offering a complimentary 30-minute consultation with Yun Lu, providing tailored insights into your RWE strategy, registry design, and data capabilities.

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..