Biometrics
Biometrics Services
Led by industry experts, Pharmaron provides quality biometrics services ranging from Phase I to Phase IV in a wide variety of therapeutic areas. We are a Medidata-accredited vendor and our team is highly proficient with Rave EDC, Balance RTSM, CTMS and eTMF and CDISC standards including CDASH, SDTM and ADaM.
Data Management
- Case Report Form (CRF, eCRF) design and review
- Randomized trial and drug supply system design
- Database design, build, test, maintain and close-out
- Double data entry and comparison of paper-form data
- Data verification and validation management
- Data transfer
- Medical coding
- SAE and External data reconciliation
- Local lab range management
- Quality assurance and data management audit
- EDC systems
Capabilities
Statistical Analysis and Programming
- Power/sample size calculation
- Protocol development and statistical methodology development
- Adaptive design methodology implementation
- Trial design input and simulation
- Statistical Analysis Plan (SAP) and mock up shells development
- Randomized schedule development and randomization list generation
- Development of study data tabulation model (SDTM) datasets
- Development of analysis datasets (ADaM) and derivation
- Creation of tables, listings, and figures (TLF)
- Support of publication and exploratory analysis
- Interim analysis
- Data Monitoring Committee (DMC) related statistical activities
- Integrated summaries of safety and efficacy (ISS/ISE)
- Annual or periodic safety reporting
- Clinical study report review
- Statistical analysis report
