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Biostatistics Services
Start early and strong with robust statistical evidence
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
Brochure
Learn how we support our clients gain statistical insights early on to maximize late phase outcomes
Consultation
Book a free consultation with our statistics experts today
Global team of expert statisticians
Strong project management and escalation framework
Well-designed SAS macros environment
Continuous support for ad-hoc analysis and quick turnaround