Statistical support throughout the development process

We provide support throughout the process of drug and medical device development, including study design, the creation of analysis databases, statistical analysis, and the reporting of study results. We have experience working with guidelines from various regulatory agencies, such as the FDA and EMA, and regularly collaborate with CROs.

With us you’ll receive expert support through every stage of development, covering both phase I-IV clinical rials and real-world evidence studies.

We offer

• Study design and development of protocols and statistical analysis plans (SAP)

• Data requests (e.g. from regulatory agencies) and database construction

• Simulation studies and power analyses

• Management of participant randomisation

• Statistical analysis of clinical trials (phase I-IV) and Real World Evidence studies

• Communication with CROs and regulatory agencies

• Development and validation of clinical prediction models using TRIPOD+AI

• Reporting and visualisation of study results

Who is this for

This service is aimed at pharmaceutical and biotech companies, government agencies, and CROs that require statistical expertise in all phases of development.