Using a Quality Management System and Risk-based Approach in Observational Studies to Obtain Robust Real-World Evidence.

The results of observational studies using real-world data, known as real-world evidence, have gradually started to be used in drug development and decision-making by policymakers. A good quality management system—a comprehensive system of process, data, and documentation to ensure quality—is import...

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Publicado en:	Therapeutic Innovation & Regulatory Science Vol. 58; no. 6; pp. 1006 - 1014
Autores principales:	Tanoshima, Reo, Inagaki, Naoko, Nitta, Manabu, Sue, Soichiro, Shimizu, Sayuri, Haze, Tatsuya, Senuki, Kotaro, Sano, Chihiro, Takase, Hajime, Kaneko, Makoto, Nozaki, Akito, Okada, Kozo, Ohyama, Kohei, Kawaguchi, Atsushi, Kobayashi, Yusuke, Oi, Hideki, Maeda, Shin, Yano, Yuichiro, Kumagai, Yuji, Miyagi, Etsuko
Formato:	research tables/charts Journal Article
Publicado:	Springer Nature Nov2024
Acceso en línea:	Ver este registro en EBSCOhost