Services

Biostatistics & Data Management

Home Biostatistics & Data Management

At ADVITY, we specialise in defining the correct study components and tools to ensure optimal efficiency in your biostatistics and data management needs. Our expert team guides your clinical trial from start to finish, ensuring data integrity and quality. We prioritise seamless execution, guaranteeing that your clinical results align with your goals and regulatory requirements, ultimately contributing to successful outcomes in your research endeavours.

Comprehensive Services

  • Statistical consulting on study design
  • Statistical analysis and reporting
  • Development of the statistical analysis plan
  • Sample size and power calculations
  • Study randomization schedule
  • Writing statistical sections of the protocol & reports
  • ​Tables, listings, figures and annexures
  • Development of CDISC, SDTM, and ADaM datasets with documentation and validation as per the applicable regulatory requirements
  • Electronic case report form (eCRF) design
  • Database design and study setup
  • Medical coding to industry standards
  • Data validation and query resolution
  • Management and reconciliation of third-party data
  • CDISC study data tabulation model mapping and consolidation

Digitalization - eDC

Clinical Site Management
  • Study administration
  • Role based access
  • Central Lab management
  • External Data Loaders
Clinical Monitoring
  • Patient visit scheduler
  • Data capture
  • Audit logs
  • Compliance monitoring
Clinical Project Management
  • Audit logs
  • IP management
Clinical Data Management
  • Data management
  • Report builder
Medical Writing
  • Document management
  • eCRF design
Statistical Analysis Services
  • Data extraction (Inputs to Stats)
Clinical Vigilance Services
  • Case processing
  • Generation of submission ready files

We are here to help you improve trial efficiency in your next project. Connect with our Director Clinical Services

Kalyan Reddy - Director Clinical
+91 40 69089999
bd@advityresearch.com