Parties will collaborate in enhancing chronic disease care therapies
Eversana, a provider of global commercial services to the life sciences industry, has reached an agreement with Janssen Research & Development, LLC to transform clinical data into the evolution of chronic disease care through real-word data (RWD), data science analysis and regulatory-grade studies. The partnership between Eversana’s RWD solution team and Janssen’s research & development data science group, the companies say, will help drive evidence-based development of Janssen therapies, treatments and patient support models.
The agreement will offer an understanding and deliver potential improvements to the clinical trial design through regulatory-grade, auditable determination of clinical endpoints, which enables studies that can shorten clinical trial timelines. Combined with its branded technology platform, Eversana’s chronic disease database is expected to cover more than 80 million de-identified patients to conduct regulatory-grade research studies, generate evidence, and provide data-driven insight to characterize baseline patient attributes, disease progression, and treatment-based outcomes for patients in chronic disease.
“We are excited about our agreement with the data science team at Janssen Research & Development to support innovation in chronic diseases,” notes Jim Lang, Eversana's CEO. “Our collaboration is focused on scaled clinical data and a scaled data science capability to accelerate clinical programs.”
Understanding the FDA's Exemption for DSCSA Compliance
November 12th 2024In the quest for achieving full traceability, the exemption applies to certain trading partners under the Act, and postpones enforcement of final compliance requirements while acknowledging progress and ongoing challenges.