We perform discrete tasks or lead comprehensive programs for your regulatory, quality and clinical requirements. We collaborate with your team to troubleshoot and achieve cost-effective and time-efficient solutions.

High quality data is essential.

We understand that a properly designed data management system is critical for the conduct of well-controlled clinical trials and timely regulatory submissions. Our staff is highly skilled at designing Statistical Analysis Plans, performing data management and analyzing data in pursuit of commercial approvals and market adoption.

Experien Group biostatistics

Our data management services include:

  • Data Management SOPs
  • Database development and validation
  • Case Report Form annotation
  • Data listings
  • Data
    • Data entry
    • Data verification
    • Data auditing (including source documents)
    • Data quality checks

  • Data summaries
  • Report tables
  • Adverse event coding and reporting
  • Data analysis for clinical reports
  • Database management:
    • Case Report Form tracking
    • Data correction
    • Database lock

Our biostatistics services include:

  • Statistical Analysis Plan
  • Statistical support for protocol development
  • Randomization

  • Analysis and summary of results
  • Analysis and tables

Experien Group Quality Systems Medical Device Consulting

We need people who can become a part of the company in order to guide us through commercialization

Client quote