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Design and Protocol Development

Study Design and Protocol Development

The Department of Biostatistics has the experience to craft optimal study designs, develop new protocols that include safety and efficacy trials, large sample-size registration trials.

The following is a summary of our study design and protocol development services:

  • Study Design
    • Phase I/II safety and dose finding studies
    • Phase II exploratory efficacy trials
    • Randomized controlled phase III trials
    • Phase III and IV trials
    • Bio-equivalence and therapeutic equivalence trials
    • Pharmacovigilance and pharmacoeconomic trials
  • Protocol Development
    • Statistical planning (sample size estimation, randomization, and approach in the statistical methods)
    • Complete protocol development
    • Case Report Form design
    • Literature review and meta-analysis
    • CRF completion guidelines

Clinical Trial and Site Management

The Department of Biostatistics offers management services by maintaining complete monitoring that commences from the site initiation till the site closure.

  • Site Initiation
    • Personnel training
    • Training for Electronic Data Capture (EDC)
  • Site Monitoring
    • Checking internal consistency of CRF data
    • Data query management
  • Project Management
    • Progress and status reports
    • Tracking CRFs and DCFs
    • On-site support and Help-desk for EDC