Biostatistics

Biostatistics is an essential component of clinical research, playing a pivotal role in the setup, conduct and reporting of trials. It ensures studies are well-designed, data is accurately collected and analysed, and results are interpreted correctly.

Setup

Biostatistical input into the setup of clinical trials is key, ensuring the right trial design and statistical methods are selected so the effect of your therapy can be detected, and the trial be efficiently delivered .

Conduct

Throughout the delivery of the trial, Biostatisticians support with a wide range of activities. This includes interim analysis as part of safety and efficacy monitoring assessments and helping to implement adaptive trial design gating decisions.

Reporting

Finally, Biostatisticians are pivotal in the reporting of trials, conducting the final analysis to interpret the efficacy and safety of your therapy, often augmenting trial data with meta-analysis and systematic review.

Smart, Streamlined Trial Design

Physiomics’ combined expertise in Modelling & Simulation and Biostatistics means that you can benefit from an integrated approach to trial design and analysis, with greater efficiency and continuity between phases of drug development. With an established understanding of your drugs preclinical and translational data, we can help set up your trial, derive relevant endpoints and inform dosing decisions in real time, within a deeper context of your drugs behaviour.

We have experience in the design and delivery of clinical trials from Phase 1 (e.g. bioequivalence, dose-escalation and dose proportionality) to phase II, through to phase III.

Our solutions include, but are not limited to:

Trial Setup

Clinical Trial Design (early to late phase)

Effective endpoint identification

Sample size and power calculations using standard and simulation approaches

Protocol and Statistical Analysis Plan (SAP) development

Data Capture Design (CRF)

Regulatory Trial Submission Support

Trial Conduct and Reporting

Interim Analysis

Adaptive trial design gating decisions

Final Analysis and Reporting (TFLs Post-hoc analysis)

Performing analysis validation

Statistical Analysis Report interpretation

Clinical Study Report (CSR) Development

Advice and Support

Biostatistics oversight of CRO/Vendor

Biostatistical Advice

Regulatory Meeting Support

Innovative Modelling and Simulation

Meta analysis and Bayesian analysis

Data Driven decision making

Interested in speaking with a consultant?

We’ll arrange a brief consultation for you with a specialist in our team.

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