BioStata: Contract Research Organisation for Clinical Trials
BioStata is a contract research organisation (CRO) specialising in data management, statistics, and DMC monitoring in clinical research.
We assist sponsors of all sizes with the biometric data services required in clinical trials, such as protocol writing, CDISC compliant data mapping , randomisation,
submission, DMC monitoring , Clinical Data Management , biostatistics and reporting
Each client is important to us
At BioStata, you are not just another client. We strive to maintain long-standing collaborations with our clients, and we value the familiarity and trust we share with each of them.
Our experienced data managers, SAS programmers and statisticians work closely with you, making sure that all clinical trial data are collected, mapped and reported correctly.
We have more than 20 years of experience in clinical trial data management and biometrics services.
This means that we know exactly how to ensure full compliance with formal data requirements and facilitate a timely, hassle-free approval process for your medical treatment or device.
Our standard operating procedures
We follow standard operating procedures with clear guidelines to ensure full compliance with all requirements from international medical authorities.
You can always rely on us to ensure that all our employees receive thorough training in our SOPs before working independently on any client project.
We adapt to your project
We have deliberately kept our contract research organisation small to be able to tailor our data management solutions to your needs rather than asking you to conform to a rigid one-size-fits-all procedure.
Our limited size and the cohesiveness and experience of our team of highly skilled specialists enable us to easily adapt to the scope of your clinical research project, be it broad or narrow.
When taking on large-scale projects, we draw on the expertise and manpower of trusted external consultants.
Among our external partners are:
JPEP Consult ApS
Headed by experienced Med.Sc.D. Jørgen Petersen Peen, JPEP Consult ApS advises on pharmaceutical drug development and drug safety.
IBM Watson Health
“As a leader in the Life Sciences industry, Biostata ApS continuously innovates, refines, and invests in accelerating clinical trials and leveraging technology to provide the highest quality of services to its customers. IBM Watson Health is proud to have partnered with Biostata over the past 10 years and we look forward to continuing this relationship in the future.”
Contact us for a quote
BioStata was founded by Bjarne Bodin in 2010. He was soon joined by Peter Lipczak, and together, they created a CRO with the deep expertise normally found in large organisations and the flexibility and unity of a tightly knit team.
BioStata is privately owned by the two founding partners, Bjarne and Peter.
CEO at BioStata Bjarne Bodin worked in biometrics for 18 years before founding BioStata in 2010.
He has an MSc in Statistics and has worked as a biostatistician and manager at various Danish organisations such as Novo, Spadille, Cyncron and BioData.
Prior to joining BioStata in 2011, Peter worked in IT and biometrics for more than 35 years, holding several management positions in various Danish CROs, including Cyncron/Medicon, BioData and Spadille, one of the first Danish CROs. Peter also has an MSc in electronics from DTU.
BioStata’s historical milestones
BioStata was founded by Bjarne Bodin
Peter Lipczak joined BioStata as a partner
BioStata assisted with their 1st DMC project
BioStata expanded and moved to larger offices in Birkerød north of Copenhagen
BioStata expanded again and moved to even larger offices in the same area
BioStata employed 14 employees and 3 freelance consultants
BioStata helped with their 1st FDA submission
BioStata handled their 80th DMC project
BioStata employed 14 employees and 5 freelance consultants