Phase I
Early-development support including safety, PK-related and exploratory analyses where in scope.
STUDY EXPERIENCE
Clinical Trial Experience
TUNECT teams and specialists have experience supporting biometrics deliverables across multiple study settings — from early development and pivotal studies to post-market, observational and device programs.
PHASES
Study Phases & Types
The contribution depends on study setting and contracted scope. Exact relevance is confirmed during scoping.
Phase II
Design refinement, endpoint strategy, interim thinking and proof-of-concept analysis.
Phase III
Pivotal-study biometrics, standards implementation, reporting and submission-oriented deliverables.
Phase IV / Post-Market
Post-approval studies and additional evidence generation.
BE / BA
Bioequivalence/bioavailability analysis planning and PK-related support.
Observational / Real-World Evidence
Analysis and reporting workflows for observational and real-world data.
Medical Devices
Pilot, feasibility, pivotal and post-market study settings.
LIFECYCLE
Across the Study Lifecycle
The role of biometrics changes from planning through reporting.
01Design
02Start-Up
03Conduct
04Interim / Review
05DB Lock
06Analysis
07Reporting
Planning a study and need to understand the biometrics scope?
Share the phase, endpoints and expected deliverables.