A Guide to Integrated Summaries of Safety & Effectiveness (ISS & ISE)
This guide demonstrates how to plan, review, produce successful integrated summaries of safety and effectiveness (ISS & ISE) for regulatory submissions
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ACR Response Criteria in Rheumatoid Arthritis Clinical Trials
ACR response criteria measures the effectiveness of various medications in Rheumatoid Arthritis (RA) clinical trials. This blog also reviews techniques to assess equivalence across time points and compare treatment response curves in RA tri...
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The Advantages of Parallel Processing Clinical Data in SAS/Connect
This blog post reviews the Advantages of Parallel Processing on the reporting and analysis of clinical trial data using SAS/Connect. Learn more with Quanticate's programming experts.
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Re-Randomization Tests in Equivalence Trials: Can We Still Use Them?
This blog post reviews re-randomization tests in equivalence trials and superiority trials and if, when and how to use them.
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FDA Guidance for Human Gene Therapy for Hemophilia A & B
This blog post reviews the FDA's guidance for Human Gene Therapy (GT) for Hemophilia A & B clinical trials and what is needed to support an accelerated approval approach. Learn More
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A Guide to Phase 1 Clinical Trial Designs
Different designs used in Phase 1 Clinical Trials suit certain study types to determine the safety, tolerability and pharmacokinetics (PK) of new compounds
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Electronic Data Capture Systems In Clinical Data Management: The myths and the reality
This blog explores myths of electronic data capture (EDC) systems in clinical data management and how it is not always expensive or time-consuming to set up
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The Different Phases of Clinical Trials
Quanticate blogs on the different phases of clinical trials that are classified into 4 phases, with each potentially lasting for several years.
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