BioStata: Your experienced data partner in clinical trials

We help sponsors worldwide submit fully compliant clinical research data for a speedier approval process. With BioStata as your contract research organisation, your clinical trial submissions are based on more than 20 years of solid experience in protocol writing, data mapping, randomisation, DMC monitoring, clinical data management, biostatistics, submission, and reporting.

Our services


Speed up the FDA approval process with CDISC-compliant data mapped correctly according to SDTM and ADaM.


Ensure full data compliance with the correct database setup and a validated, user-friendly CDM system.


Keep your data management FDA compliant in clinical trials with DMC oversight.


Get valid statistical data from phases I to IV and ensure timely submissions.

3 reasons to choose Biostata

01. Experience matters

With more than 20 years of experience in biometrics, we are well-versed in formal data requirements and ensure that you submit fully compliant trial reports.

02. Teamwork matters

At BioStata, your clinical trial data are safe in the hands of a tightly knit team of experienced specialists who pull together to get your data ready for submission.

03. Flexibility matters

As a flexible organisation with solid relations to trusted collaboration partners and skilled freelance consultants, we can easily adapt to the scope of your project, be it broad or narrow.

Some of our clients say:

I have always been happy with the work performed by BioStata. Their professionalism and dedication towards the assignments ensure timely deliverables of high quality. I have many times used their expertise when it comes to administration and data analysis in relation to Data Monitoring Committees data, and can recommend others to use their skills and profound knowledge in this context.

Tina Maria Greve
Senior Drug Safety Advisor at ALK

BioStata has provided us with statistical advice and data analyses. It has been a pleasure working with the people at BioStata due to the flexibility they have shown, their timely deliveries, and the fact that BioStata have excelled at communicating statistical matters to non-statisticians, enabling us to collaborate efficiently to the benefit of the project.

Henrik Blou
CEO at Aros Pharma ApS, Denmark

Get in touch

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