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Study Design and Protocol Development SciAn Services has acquired the experience to create optimal study designs and develop protocols for research programs that extend from dose-finding safety and efficacy studies to large sample-size registration trials and pharmacoeconomic evaluations. Our personnel have the experience and the knowledge in all areas of clinical research, biostatistics, and regulatory issues to provide consultative recommendations or lead the design of your study as required. The following is a summary of our study design and protocol development services: |
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• Study Design - Phase I/II safety and dose finding studies - Phase II exploratory efficacy trials - Randomized controlled phase III trials - Phase IIIb and IV trials - Pharmacokinetic and dynamic studies - Bio-equivalence and therapeutic equivalence trials - Pharmacovigilance and pharmacoeconomic trials • Protocol Development - Statistical planning (sample size estimation, randomization, and power calculations) - Complete protocol development - Case Report Form design - Literature review and meta-analysis - CRF completion guidelines - Client representation or support at regulatory meetings (INDs NDAs) |
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