bio
statistics

Answers from data.

Biostatistics

your study within 4 steps

Adaptive methods, Precise Execution
2

study set-up

Data collection tools review as part of a cross-functional team to ensure that data is collected:
  • In a clear and concise manner for the investigator
  • Efficiently for Data Management processing
  • Optimally for statistical analysis
Complete Data Management documentation creation, review and distribution
  • Data Management Plan (DMP)
  • Completion guidelines
  • Data Validation Plan (DVP)
  • SAE Reconciliation Plan
  • Specific reports
  • Data transfer protocol
Computerized system
  • Design: Annotatation, Development specifications creation and validation
  • Extensive testing and validation experience
  • Documentation
  • Training
3

in life study progress

Data life cycle
  • Cleaning, validation and discrepancies management
  • Holistic review for data quality and data acceptance
  • Data transfer
  • Interim database lock
Computerized system
  • User account creation and management
  • Change control management
  • Change control management
  • Refresher training
Reported terms management
  • Advers Events coding
  • Serious Adverse Events reconciliation
Data Management documentation
  • Update and maintenance
Study follow-up
  • Standard and custom reports
  • Standard and custom dashboards
4

Study End

Data end point
  • Final discrepanties management
  • Final quality control
  • Final accuracy audit
  • Final database transfer
Data Management documentation
  • Final database lock request form completion and validation
  • Final Database lock form completion and validation
  • Final Data Management Report
  • Archiving
Computerized system
  • Final database lock request form completion and validation
Reported terms management
  • Final Advers Events Coding
  • Final Serious Adverse Events reconciliation
Database final lock

revelancy from compliancy

We guarantee the validity of your answers

Answers are useless unless extracted through a compliant process. Our compliancy is your guarantee.

This is why we ensure 100% norms compliancy

  • ICH - GxP
  • E9 statistical principles for clinical trials
  • E3 sructure and content of clinIcal study reports

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