We pave the path from data points to actionable results.
Our experience
Leading Czech company for statistical and data management services for pharmaceutical and biotech industry. Offering working models from end-to-end to contract staffing. With over than 15 years of experience and many successful projects, we are the solid partner for your research.
expertise
Study design selection
Sample size calculation / Power analysis
Statistical part of study synopsis and protocol writing
Statistical Analysis Plan (SAP) and Statistical Interim Analysis Plan (SIAP) writing
expertise
Programming of 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
Creating and executing SAS edit check programs
expertise
Development of protocol specific electronic Case Report Forms (eCRF)
Clinical database setup and validation
Quality assurance (QA) and Quality control (QC) including data quality control checks and data clarifications
Database lock
expertise
CDASH (Cllinical Data Acquisition Standards Harmonization) followed in CRF design
SDTM (Study Data Tabulation Model) domains preparation adn datasets programming
ADaM (Analysis Data Model) datasets programming
Define.xml creation
expertise
Medical coding using standard dictionaries (MedDRA and WHO DD)
Medical review - professional audits on medical records to identify safety issues and ensure data consistency
Customized approach based on the indication and phase of the clinical trial
expertise
Interim analysis for open-label and blinded studies
DSMB: complete management organizational and technical
Preparation of materials for open and closed sessions of DSMB
Have us dig through your data and make a sense of it. We will bring you the clarity you need to achieve your goals.
ANOVA CRO s.r.o.
Zelená 2002/21a,
160 00, Praha 6 Dejvice
Id. Nr.: 09380779
Registered at the Municipal Court in Prague, Section C, File 335451
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