Overview

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.

Services

Services

Data Management

  • 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

Software Development

  • 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

Statistical programming and analysis

  • 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

Contact Us

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