We're analytical, adaptive, and dedicated to data science for continuous improvement.

Data Management, data analysis and statistical computations play a large part in the clinical trial process and health technology assessments. From the analysis of existing data to predict outcomes, to the ongoing analysis required to adapt trials and avoid risk, data is everywhere. It’s used to provide input to early development. It’s used to predict adverse events. Used to measure the quality of work from partners. The list goes on.

Biometrics is an essential component of all areas of clinical trials. Metrics help to identify a strong target profile, monitor plans that reduce risk and prove efficacy and safety. So PSNResearch has developed a special team to use statistical modelling and analysis for everything from improving study design to determining endpoints to writing submissions for maximum effect and adherence to regulations.

The way we use data helps estimate, define and prove patient outcomes. We use the latest data capture technology and collect and control data from multiple sources. Our two data storage facilities, one in the US and one in EU, provide redundancy. Like the rest of our services, our biometrics capabilities can be purchased on a consulting or full-service basis.

Strategic Consulting

  • Data monitoring processes including a Risk Based Monitoring approach
  • Data monitoring boards

Data Management

  • EDC
  • ePRO
  • IWRS
  • External Data Management from central lab or all other external data sources
  • Continuous Data Review / Final Data Review
  • Soft Lock / Hard Lock
  • CDISC or Sponsor format Datasets for submission purposes

Statistical Consulting

  • Study design
  • Endpoints
  • Sample size
  • Study protocol

Statistics

  • Creation of SAPs
  • Creation of TLFs
  • Interim planning and reporting
  • DSMB support

Data Analytics

  • Adaptive study implementation
  • Artificial Intelligence
  • Algorithms

PHARMACOVIGILANCE >