Biometrics at CliniRx efficiently undertakes the management of clinical trial data. Using internationally approved and validated software platforms, our data management experts offers accurate collection, organization, validation, statistical analysis and reporting of clinical trial data. Our experienced and expert biostatisticians provide excellent statistical services for clinical trial management.
Data Management Services
Biostatistics Services
Medical Writing Services
Software Tools & Platforms
Data Management Services
- Generating data management plans
- Compiling Edit Specifications (edit checks)
- Database creation
- Dictionary processing and coding
- Case report form designing and review
- Import and verification of central and local laboratory data
- Electronic data capture
- Double data entry
- Query generation and resolution
- Data transfer and management
Biostatistics Services
- Statistical consulting
- Sample size calculation
- Protocol and CRF development/review
- Randomization schedules
- Development of statistical analysis plans (SAPs)
- Statistical analysis
- Programming of tables, figures and listings
- Statistical reporting
- Input into the integrated clinical/statistical reports
Medical Writing Services
CliniRx has a team of highly skilled medical writers that can add value to your research program by clearly and accurately writing the medical documents as per the development program requirements. Our commitment to strong medical communications will provide you with consistent medical documents that will stand up to regulatory and industry assessments.
The Services Include:
- Protocol Writing
- IB Compilation
- Informed Consent Documents
- Clinical Study Reports
- Dossier for Regulatory Submissions
Software Tools & Platforms
CliniRx was the FIRST organization in India to implement the entire suite of Oracle Pharmaceutical Application. Our Data Management and Parmacovigilance runs on state of the art, fully validated Oracle Platform which includes:
- Oracle® Clinical
- Oracle® Thesaurus Management System
- Oracle® Remote Data Capture
- Oracle® Adverse Event Reporting System
- Oracle® Trial Minder
- Oracle® Site Minder
For Statistical Analysis, CliniRx uses fully validated SAS® Program.
At CliniRx, the entire IT backbone is 21 CFR (part 11) compliant; and adheres to the highest levels of data security