PubMed Journals Articles About "Therapure Biopharma Inc." RSS

20:12 EDT 20th August 2018 | BioPortfolio

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Showing "Therapure Biopharma" PubMed Articles, all 2

Rethinking the Clinically Based Thresholds of TransCelerate BioPharma for Risk-Based Monitoring.

The quality of data from clinical trials has received a great deal of attention in recent years. Of central importance is the need to protect the well-being of study participants and maintain the integrity of final analysis results. However, traditional approaches to assess data quality have come under increased scrutiny as providing little benefit for the substantial cost. Numerous regulatory guidance documents and industry position papers have described risk-based approaches to identify quality and safety...

The positive impacts of Real-World Data on the challenges facing the evolution of biopharma.

Demand for healthcare services is unprecedented. Society is struggling to afford the cost. Pricing of biopharmaceutical products is under scrutiny, especially by payers and Health Technology Assessment agencies. As we discuss here, rapidly advancing technologies, such Real-World Data (RWD), are being utilized to increase understanding of disease. RWD, when captured and analyzed, produces the Real-World Evidence (RWE) that underpins the economic case for innovative medicines. Furthermore, RWD can inform the ...

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