One of our main differentiating factors is our Biometrics department. We are delighted to position ourselves as a biometrics-oriented company heavily focused on developing cutting edge technology such as our state-of-the-art EDC platform.

Our biometrics unit comprises of highly skilled data management, statistical analysis and software development teams each uniquely fitting into the one common path: efficient processes and reliable study data.

It is through our in-house technology and technical expertise of our people that we can offer complete flexibility to the client and deliver this highly promised and talked about level of quality.

a cloud with one arrow pointing up and one pointing down, biometrics page
  • From CRF design to legacy database integration
  • Development and execution of study specific Data Management Plan
  • Development and execution of study specific Data Validation Plan
  • Coding accuracy and consistency. Support all dictionaries
  • Metrics of clinical activities and support to clinical project management
  • Queries Resolution and management
  • Merging and Consolidation of Safety and Clinical databases
  • CDISC: Development of SDTM/ADaM datasets. Data preparation for regulatory submissions
  • In house developed eCRF platform supporting all functions (SDV, drug management, eSAE, ePQC ePregnancy, notifications etc)
  • Complete customization throughout the project to suit client needs, changes implemented ASAP
  • Comprehensive audit trail logs of all user activity
  • 21 CFR part 11 compliance
  • GDPR compliance
  • Validated library of SAS© programs
  • Statistical Design of all aspects of a clinical trials / Endpoint selection and validation
  • Statistical Analysis Plan (SAP)
  • Sample Size / Interim Analysis Plan
  • Tabulations, Listings and Graphical Presentations
  • Statistical Reports
  • Statistical input and review of clinical study reports and publications

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