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Integrated Summary Tips

Medical Writing Team


Quanticate's Medical Writing Team have summarized tips for the preparation of comprehensive, well-written, and focused integrated summary documentation.

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Topics: Regulatory Requirements, ISS/ISE, FDA, Integrated Summaries, Integrated Summary of Safety, Integrated Summary of Efficacy

Using CDISC SDTM to Improve Cost and Quality in Integrated Summaries

Clinical Programming Team

 

 

Following on from our previous blog posts on Integrated Summary tips, another aspect that can be considered is the cost and quality of producing integrated summaries and how CDISC and CDASH can aid in reducing costs and improving quality for ISS ISE submissions.

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Topics: Regulatory Requirements, CDISC Guidelines, CDISC SDTM, SDTM Domains, CDISC, ISS/ISE, FDA, Integrated Summaries, Integrated Summary of Safety, Integrated Summary of Efficacy, Standardization

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