Finding the answers in your observations

We pave the path from data points to actionable results.

Statistics & data management

pharma
biotech
devices

Our experience

Your solid partner

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

Statistics

1

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

SAS programming

2

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

Data management

3

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

CDISC

4

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 information

5

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 and support for Data and Safety Monitoring Board (DSMB)

6

Interim analysis for open-label and blinded studies

DSMB: complete management organizational and technical

Preparation of materials for open and closed sessions of DSMB

Work with us

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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