Biometrics
Improve the efficiency of your trials and reduce the risk of failure
From database build and quality checks to statistical analysis and programming, our team ensures accurate and reliable handling of your trial data. D2V Clinical specializes in CDISC data standardization and electronic submission packages, providing seamless compliance with industry regulations. With early insight into emerging trends and proactive interim data review, we help you make informed decisions and minimize risks.
Data Management
- Case report form (CRF, eCRF) development acrossmultiple platforms
- Randomized trial and drug supply system design
- Database design, build, test, and maintenance
- DMP development
- Data visualization support
- Double data entryand comparison of paper-formdata
- Data review and query management
- Standard & Customized Reports for Data Review &Metrics
- Medical coding, SAE reconciliation, external datamanagement
- Quality assurance and data management audit
Statistical Analysis and Programming Services
- Clinical trial design
- Sample size calculation
- Clinical trial protocol drafting
- Statistical analysis plan and shells
- Randomization and blinding
- Creation of CDiSC compliant SDTM/ADaMdatasets
- SAS programming
- Sensitivity and exploratory analysis
- Standardized data coding according to MedDRAand WHO Drug
- Interim analysis
- Data Monitoring Committee (DMC) related statistical activities
- ISS/ISE plan and analysis
- Scheduled provision of medical data review listing and data visualization reports
- Creation of submission support documentation,to include aCRF, SDTM/ADaM Reviewer's Guides,Define.xml and BlMo listings
- Regulatory interactions
- Clinical outcome assessment (i.e.instrument) validation
- Safety updates and medical affairs
Technology Standards
- CDISC clinical trial data standardization and electronic submission package
- Early insight into early signs of clinical trials
- Electronic data capture (EDC) system implementation and support
- Metadata management and standardization
- Regulatory compliance and submission support