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