Capabilities

Core Capabilities

Clinical trial operational support

Study startup and regulatory coordination

Monitoring support (remote and on-site)

Documentation review and quality control

Sponsor and CRO communication support

Compliance & Standards

ICH-GCP compliance

FDA regulatory awareness

IRB coordination support

TMF support and document management

Operating Model

ModeI functions as an extension of sponsor and CRO teams, supporting efficient execution while maintaining regulatory and quality expectations.