Biostatistics Services

Start early and strong with robust statistical evidence

Leveraging Biostatistics to make informed decisions

In early-stage development, poor scientific planning can result in overlooking critical safety signals, and faulty estimations of drug candidate potential, resulting in very expensive late phase failures. This not only impacts the cost of development but also leads to loss of time to market and reduced valuation of the product. Algorics biostatistics centre of excellence is a team of statistical experts with extensive experience in optimizing early phase development, PK/PD analysis and supporting large global programs.

End-to-end biostatistics support from
protocol to clinical study report

PK/PD analysis across drug types

FSP model for dedicated statisticians and support statisticians

Team of 10+ expert biostatisticians

Write and review statistical section of study synopsis and protocol

PK/PD analysis

Sample size estimation

Creating specification document for CSR preparation

Develop and review SAP and mock shells

Write and review statistical sections of CSR

Safety analysis and statistical report preparation for dose escalation meetings

Post-submission regulatory query resolution

Study types

  • First in human studies

  • Dose escalation studies

  • Single and multiple ascending dose

  • Bioequivalence and bioavailability

  • QT/QTc studies

Study designs

  • BOIN (Bayesian Optimal Interval)

  • Traditional 3+3

  • Crossover

  • Parallel

  • Adaptive trials

Product types

  • New chemical and biological entities

  • Biosimilars

  • Complex generics

  • Global generics


Learn how we support our clients gain statistical insights early on to maximize late phase outcomes


Book a free consultation with our statistics experts today

Why Algorics?