Clinical Data Management- Experience with working remotely on customer CDM systems
- Customised database design according to CDISC SDTM or customer specification
- Paper-based (Framemaker, Acrobat) and electronic CRFs
- Full range of CRF printing and configuration possibilities
- Complete printing administration and CRF shipment and tracking
- CRF annotation, definition of data handling manual and data validation plan
- CRF tracking and secure storage of CRF originals
- Double data entry
- Data validation and query processing
- Medical and data management quality review of CRF and external data
- Database and data entry quality control prior to database lock
- Medical coding and review expertise (e.g. MedDRA, WHO Drug Dictionary, WHO ART, COSTART)
- SAE and external data reconciliation
- CDISC SDTM supported
- Definition and implementation of integrated data structure across clinical studies
- Maintaining database
- Providing continuous import of generated data
- Data review and reporting tasks including customised reports
- Overall-, subgroup- and meta-analyses
Biostatistics- Statistical planning of clinical trials with sample size calculation in accordance with ICH E9 and other ICH, CPMP or FDA guideline
- Providing random codes (e.g. envelops, randomisation lists)
- Statistical Analysis Plan
- Production of mock-up tables and listings
- Conducting statistical analysis
- Production of statistical or integrated reports
- Attending meetings with regulatory bodies
- Deploying SAS, StatXact, Addplan and NQuery Advisor
- Support of CDISC SDTM and ADaM standards
Medical Writing and Clinical Study Reports- Expert reports
- Integrated clinical study reports according to ICH E3 guideline
- Writing and reviewing by physicians and statisticians
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