Statistical Services
From analytical data to informed decisions.
At Quality Assistance, we turn your analytical data into reliable, compliant and actionable insights. We offer specialised statistical and data management services for the pharmaceutical industry. These are available either as an extension of our analytical expertise or as independent solutions.
In today’s data-driven landscape, your analytical results must be findable, accessible, interoperable and re-usable (FAIR). Our statisticians and data specialists work closely with your teams to ensure your analytical results are scientifically sound, compliant and ready to support confident decision throughout your product development and lifecycle.
Our services
Analytical Data Management
We capture and structure analytical data in digital, standardised formats. We design fit-for-purpose data outputs and ensure (upon request) smooth data exchange between systems.
Our services include:
- Data management plan creation
- Data model development
- Data exchange and reconciliation
- Data cleansing and anonymisation
- Data exploration and analysis
You get clean, compliant and ready-to-use data that accelerate your development.
Statistical analysis and reporting
We perform regulatory compliant statistical analyses to support your analytical studies. Our statisticians can assist you in extracting the best value of your data. Therefore, they use validated tools and methods to ensure robust results.
We typically support you with:
- Design of Experiments (DoE) and method optimisation
- Data interpretation, control charts and trending
- Method validation with strong statistical power
- Stability studies for chemical and biological products
- Method lifecycle management: transfer, bridging and equivalence
- Advanced modelling
We deliver clear, reliable and regulatory-aligned results that support your scientific conclusions.
Regulatory framework
All activities are performed in accordance with ICH and USP guidelines. At Quality Assistance, our statistical services directly support the implementation of analytical method by providing validated methodologies, data analysis and regulatory justification fully aligned with these standards.
Tools and compliance
We use validated tools to deliver accurate and compliant statistical analyses. Our toolbox includes:
- MS Excel to manage, exchange and present analytical data efficiently
- E-Noval / Seelva to support validation of analytical methods based on total error approaches
- PLA to perform relative potency analysis (e.g. potency assays, ELISA, Biacore)
- JMP / R / Python to support all types of (bio)statistical analysis with flexibility
Other validated or client-requested software solutions may be considered upon request.
Get the most of your analytical data
Our statistical experts help you design studies, analyse data, validate and monitor methods with precision.
Let's discuss your project
We apply advanced statistical tools, including Design of Experiments (DoE), across the entire method lifecycle, from development and robustness assessment to validation, transfer and routine testing.
We perform statistical modelling, parallelism testing and potency, ensuring reliable and interpretable bioassay results.
We ensure proper data treatment, presentation and interpretation in compliance with statistical best practices.
