Data management & Statistics
Our specialists in the area of data management, statistics and medical informatics guide through the whole course of the clinical study. From the project idea to data capture right to the analyses. We consult and support our clients with our specialist expertise and a comprehensive range of services.
iOMEDICO is a gold member of the Clinical Data Interchange Consortium (CDISC). The proprietary web-based iOstudy office edc 6.0. has been developed with our long-lastingstanding and practical experience in the documentation of oncological study projects and uses CDISC standards (CDASH, SDTM and ADaM) throughout.
- Study concept including selection of suitable study design, appropriate endpoints and statistical methods
- Proposal of hypothesis and sample size calculation based on oncological literature research
- Indication-specific statistical consultation
- eCRF development
- Implementation of automatic data checks
- Testing and validation based on GAMP 5 and according to the specifications of FDA 21 CFR part 11
- Compilation of data management and data validation plans
- Risk-based Monitoring
- Compilation of the statistical analysis plan.
- Compilation of the biometric statistical report
- Development and validation of study specific and overall analysis program (SAS)