Biometrics
Biotrial’s Biometrics Group provides support for the collection, management, analysis, and reporting of data from Preclinical to Phase I-IV clinical trials.
More about our Biometrics Services
Our Biometrics Unit has gathered a great deal of experience applicable on the following types of projects:
- Preclinical Studies
- Phase I / Clinical Pharmacology
- Phase II / III / IIIb Trials
- Phase IV Observational/NIS
- Retrospective Trials
- Early Access / Expanded Access
- Meta-Analyses and Pooled Projects
Tools and Standards
Data standards
- CDISC compliant (SDTM, ADaM, SEND)
- Define.xml, ADRG, cSDRG, nSDRG
- Deliverables for FDA and PMDA submissions
- ICH
- FDA 21 CFR Part 11
Biotrial Tools
- SAS® for deliverables programming
- EDC: Medidata Rave® and Clincase®
- ePRO: Medidata® and Clincase®
- Randomization (IRT, IWRS), Drug Supply, Coding, PV modules
- Phoenix WinNonlin®
Added values
Methodology and Solutions Consulting
Experts that help sponsors design successful trials
Solutions tailored to project needs
Tools and project teams that bring value to a sponsor project
CDISC Expertise
Providing CDISC deliverables to sponsors since 2009
Therapeutic Area expertise
Expertise in the collection and analysis of various specific endpoints
Our team
Our team includes experienced, dedicated and highly skilled Data Managers, Biostatisticians, Study Builders, Programmers, Medical Coders, CDISC Experts, Pharmacokineticists and Medical Writers.
Our Biometrics Team can help you at any stage of your project and provide a personalized service with an organization adapted to your needs.
