Pre-Clinical studies (Pharmacology & Toxicology studies)
BA/BE (Bioavailability & Bioequivalence ) studies
Phase I - Phase IV clinical studies
Study Designs |
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Sample Size |
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Randomization |
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Statistical Inputs in Protocol |
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Statistical Analysis Plan |
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Dataset and TLF (Table, Listing, Figure) specification |
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CDISC (SDTM/ADAM) Implementation |
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TFL mock-Shell preparation |
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Statistical Analysis |
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Regulatory requirement and Query |
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Statistical Report |