Biostatistics plays a vital role in clinical research. From protocol development and clinical trial designs to sample size calculation, data analysis and more, our team of Biostatisticians has the right SME expertise in multiple therapeutic areas to help deliver quality outcomes quickly and efficiently.

You can rely on us to determine and apply the appropriate statistical model, write CSR sections to interact with regulatory authorities, and examine the efficacy of safety data. Innovative and insight-driven statistical methods play a crucial role in every step of the drug development process. At ACL Digital, biostatistics remains an integral part of our services.

Biostatistics Team

 

Helping You Navigate the Complexities 

 

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  • Independent Statistical Services
  • Clinical Trial Design and Protocol Development
  • Adaptive Trial Design
  • Bayesian Model
  • Sample Size Calculation
  • Randomization Schedule
  • Statistical Analysis Plan Development
  • Mock-up Shells Development
  • Support for Data Monitoring Committees (DMC)/Data Safety Monitoring Board (DSMB)
  • Interacting with Regulatory Agencies
  • Integrated Safety and Efficacy Analysis (ISS/ISE)
  • Interim Analyses
  • Writing Statistical Aspects of the Clinical Study Report
  • Hands-on Programming Support