(phases I-IV of clinical studies and scientific studies).
we have experience in both small projects (bioequivalence studies)
and large multicenter studies. We have worked with Polish
companies and foreign entities located all over the world. The
largest study we have dealt with involved more than 6,000 patients.
- Planning the design and sample size of a study
- Selection of statistical methods
- Development of a randomization list and overseeing the
process of randomization
- Planning and overseeing data management
- Development of a CRF template based on the protocol
- Establishment of an electronic database (eCRF)
- Data quality control
- Development of a Statistical Analysis Plan (SAP)
- Computations and statistic reports
We work in strict accordance with regularly updated Standard
Operating Procedures (SOP).