Fully compliant clinical research data for a faster approval process
Are you looking for assistance with the data handling of your clinical trials? At BioStata, we help sponsors keep their clinical trials on track by assisting throughout the process – from structuring the study design to delivering submission-ready data. Are you interested in learning more about our biometric expertise and how our services can help you – please fill out the form and let us have a preliminary talk.
Let us discuss your clinical trial
Fill out the form and we will get back to you to schedule a meeting regarding your clinical trial.
Biometric services –
adapted to your requirements.
With extensive industry knowledge, we know that every clinical trial is different.
Therefore, we always begin every new project by mapping out the priorities and objectives of the trial as well as time frame and budget. These are important to us in order to tailor our services to your scope.
A deep understanding of your trial gives us the necessary insights to challenge your study design and setup to ensure you valid results and avoid you spending unnecessary resources.
Would you like to discuss your current or next clinical trial?
Fill out the form, and we will reach out to you as soon as possible to discuss how to protect your clinical trial from avoidable mistakes and setbacks using valid and submission-ready clinical data.
Our services include:
- Protocol input, including advice on trial designs,
sample sizes calculations, etc. - Randomization, e.g., code lists, envelope handling or via IWRS
- CDISC data mapping
- eCRF setup
- Clinical data management (CDM)
- Statistical planning, including statistical analysis plans,
table-figures and listing shells - Statistical reporting, including key result meetings
- Integrated clinical statistical trial reports and statistical reports
- MW via partner
- Statistical CTD support
Are you curious about one or more of our services?
We are more than happy to help you with anything – big or small matters –
so please don’t hesitate to reach out.