Biometrics
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.
- 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
