The FDA‘s recent guidance on using real-world evidence (RWE) in observational research has opened new pathways for innovation in healthcare research. As we embrace these changes, it’s crucial to consider how we can further enhance the utility of #RWE. Here are three pivotal areas where expanded FDA guidance could significantly impact the future of healthcare and lifesciences:
🔸Expanding Real-World Data (RWD) Definitions: Broadening the scope of what constitutes RWD will enable more comprehensive data collection and utilization, driving richer, more diverse studies.
🔸Incorporating Novel Data Sources: Addressing and integrating emerging data sources into RWE research can capture a wider spectrum of patient outcomes.
🔸Harmonizing with Global Standards: Establishing consistency with international guidelines ensures global applicability and relevance of RWE, facilitating lifesciences.

These enhancements also open a significant opportunity for integrating AI and Machine Learning to enhance the analytical capabilities of RWE studies, providing deeper insights and more robust outcomes.

Clinakos Inc. spearheads the integration of key technological and strategic solutions to redefine lifesciences excellence. Discover how our core offerings are making a significant impact with:
🔷Integrated Patient Data™ : Clinakos’ proprietary platform curates vast amounts of historical and real-time patient-level data, including unstructured data from primary sources.
🔷Medically Smart AI™ : By integrating AI and machine learning, Clinakos can analyze complex datasets to uncover deeper insights and more robust outcomes.
🔷Rare Disease & Oncology Focus: Clinakos unique partnerships give us access to 1300+ Disease Panels, 3000+ Advocacy Groups, Registries & Referral Partners and 750k HCPs focused on such diseases.

Our proactive approach not only complies with evolving regulatory standards but also leads the way in delivering smarter, more impactful solutions in life sciences. Link to the FDA guidance and Clinakos’ capabilities is provided below.

FDA Guidance

Clinakos capabilities