{ Study Design and Protocol Development }
The best clinical study and protocol designs are those that are formulated from the very beginning with the requirements and preferences of regulatory agencies in mind. DaVita Clinical Research (DCR) scientists are thoroughly knowledgeable in the regulations, requirements, and report formats of the FDA and other regulatory agencies and can help design studies with the best chance of approval.
DaVita Clinical Research can help evaluate alternative study designs, calculate sample sizes and sampling times, recommend randomization and blinding techniques, and advise on formulation of PK/PD parameters.
The studies we perform:
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First-in-man
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Radiolabeled
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Interactions
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QTc
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Bioavailability/bioequivalence
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Single/multiple ascending dose
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Pharmacokinetics/pharmacodynamics
