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Tag: 证据和准入

EMPLOYING REAL-WORLD EVIDENCE TO IMPROVE CLINICAL TRIAL STRATEGIES

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By: Sumeet Bakshi, Vice President, Real World Data Solutions, Certara’s Evidence, Value & Access groupRichard Tao, Associate Principal Regulatory Writer and Submission Leads Member, Synchrogenix, Certara’s regulatory science company Employing real-world evidence allows for the study of many aspects of diseases, such as natural history, patient populations, and outcomes, under everyday conditions. Therefore, real-world evidence has many … Continued

Commercial and Regulatory Success in Accelerated Gene Therapy Development

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Thanks to regulatory frameworks and driven by high unmet patient needs, the pace for clinical development of gene therapies (GT) is often greatly accelerated. This presents GT innovators with the opportunity to reach their patients faster, but it also raises the bar for critical decision points such as around trial design, endpoint selection and population … Continued

为患者提供基因疗法

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This blog discusses the challenges that drug developers face in getting patients access to cell and gene therapies as well as some potential solutions.

Getting Real with RWE

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By Taren Grom Real-world evidence, important for regulatory decision-making, is beginning to touch all areas of the healthcare value chain.

SNDS: Strengths, Limitations and Perspectives for the Largest and Richest Real-World Database in EU

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In this webinar, our experts provided an overview of the SNDS and the key working practices to access the database and ongoing SNDS developments, explained the similarities and differences between SNDS and other claims databases, used case studies to illustrate its strengths and opportunities, and provided stakeholder perspectives on current and potential benefits to patients, … Continued

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