Phase III oncology
Adaptive design for a multi-center oncology trial
Sample size re-estimation and interim analysis reduced total enrollment by 22% while preserving statistical power.
View caseStatistics & data management
Finding the answers in your observations.
We pave the path from data points to actionable results. A Czech CRO with 15+ years of experience for pharma, biotech and medical devices.
- 15+
- years experience
- 100+
- delivered studies
- 3
- sectors served
Your solid partner
Serving pharma, biotech and medical devices.
Leading Czech company for statistical and data management services for the pharmaceutical and biotech industry. Working models range from end-to-end study delivery to contract staffing. With over 15 years of experience and many successful projects, we are the solid partner for your research.
pharmabiotechdevices
Case studies
Selected work, anonymized.
A glimpse of the studies we've supported — from adaptive trial designs to regulatory-ready CDISC packages.
Rare disease
Survival analysis for a rare-disease registry
Kaplan–Meier and Cox modeling across 8 European sites, delivered SDTM/ADaM package ready for regulatory submission.
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Meta-analysis
Pooled meta-analysis across 14 studies
Harmonized heterogeneous endpoints and produced a forest plot and sensitivity analyses for a biotech sponsor.
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Data management
eCRF & CDISC conversion for a medical device study
End-to-end database build, edit-check programming and CDISC SDTM conversion delivered inside a 12-week window.
View caseExpertise
Six disciplines, one team.
A focused set of services that cover a clinical trial from first protocol draft to final database lock.
- Statistics01
- Study design selection
- Sample size calculation / Power analysis
- Statistical part of study synopsis and protocol writing
- Statistical Analysis Plan (SAP) and SIAP writing
- SAS programming02
- Summary tables, data listings, graphs and derived datasets
- Generation of Tables, Figures and Listings (TFLs)
- Conversion of data to CDISC SDTM and ADaM format
- Creating, validating and executing SAS programs and macros
- Data management03
- Development of protocol specific eCRFs
- Clinical database setup and validation
- QA / QC checks and data clarifications
- Database lock
- CDISC04
- CDASH followed in CRF design
- SDTM domains preparation and datasets programming
- ADaM datasets programming
- Define.xml creation
- Medical information05
- Medical coding using MedDRA and WHO DD dictionaries
- Medical review — audits on records for safety and consistency
- Customized approach based on indication and trial phase
- Interim analysis & DSMB06
- Interim analysis for open-label and blinded studies
- DSMB: complete organizational and technical management
- Preparation of materials for open and closed DSMB sessions
What clients say
Trusted by sponsors across Europe.
“ANOVA delivered a clean, auditable SDTM package on a tight timeline. Their statisticians pushed back on the right assumptions — exactly what we needed.”
Dr. M. Kessler
Head of Biometrics, mid-size EU biotech
“Precise, responsive and quietly meticulous. The interim analysis was airtight and the DSMB materials required almost no rework.”
S. Vermeulen
Clinical Operations Director, specialty pharma
“A rare partner that treats data management as a discipline, not a checkbox. Fifteen years of experience shows.”
Prof. J. Havel
Principal Investigator, academic consortium
Work with us.
Have us dig through your data and make sense of it. We will bring you the clarity you need to achieve your goals.
Contact us