Statistical services

Beyond analytical services, Quality Assistance provides advanced statistical consulting and analytical data management services. We regularly support clients in order to comply with recommendations of ICH, USP, and other regulatory bodies. For more specific needs, our team can also develop individual solutions to assist in extracting the maximum value of the generated data.

Analytical data is captured in a standardised digital format for all statistical analysis requests. More comprehensive data models can be developed when needed to fulfil client expectations more precisely, support data exchange and transfer, etc. 

For data analysis purposes, Quality Assistance statisticians employ a full range of statistical tools in order to provide the best response to any client request in full compliance with the cGxP regulations. Moreover, Quality Assistance can develop specific analytical or modelling services, based on less common or emerging approaches (e.g. Bayesian analysis), in order to address your specific innovative research and development needs.

Quality Assistance Statistical services

Our expertise

Data Management

  • Data management plan elaboration

  • Data model development

  • Data exchange (import/export) & reconciliation

  • Data cleansing & anonymisation

  • Data exploration & analysis

Full access to the following tool box

  • MS Excel expert & advanced tools

  • e.noval
    Other similar solutions may be considered upon request

  • PLA

  • JMP
    R, Python

Statistial analysis and reporting

Our highly skilled team performs analyses upon request and provides the appropriate expertise to support clients in maximising the generated data.

Our statisticians are here to assist you with the following approaches: 

  • Design of experiments for study of NBEs, NCEs, CBMPs, GTMPs, etc.

  • Analysis and interpretation

  • Validation

  • Stability assays

  • Analytical procedures

  • Analytical procedure lifecycling 

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