Integrated Clinical Site Management and Risk-Based Monitoring
We don’t just check boxes. Our oversight starts with a routinely updated risk assessment register and a monitoring plan that scales with the complexity of your protocol. Then, leveraging deep GI expertise and long-standing site relationships, we accelerate activation and drive recruitment momentum:
Rapid activation
We run workstreams in parallel to accelerate site activation, ensuring investigators and coordinators have practical training and quick reference guides from day one
Relationship-driven recruitment
Leveraging our knowledge of and relationships with sites, our Site Engagement team engages with them to identify recruitment barriers and implement mitigation strategies early
GI-specialized CRAs
Our monitors are trained specifically in GI indications, so they understand the complexity of the protocol and provide meaningful guidance to site staff
RBQM for Smarter, Data-Driven Trials
Our site management moves beyond 100% source data verification (SDV) with imbedded risk-based quality management (RBQM), using a study-specific risk register to drive action, not just paperwork:
Targeted verification
Source data verification and review (SDV/SDR) levels are set by risk and adjusted as the study evolves
Data signals
We utilize centralized reviews to catch outliers, missing data, and protocol drift early, allowing for remote intervention before issues escalate
Action over status
Every finding is tracked with a clear owner, due date, and proof of closure
Imaging Coordination and Central Reading
In GI trials, imaging is often the primary endpoint. We integrate imaging oversight directly into our site management plan to ensure:
Synchronized scheduling
We coordinate site monitoring visits with central reading requirements to ensure data flow remains uninterrupted
Technical quality
Acquisition standards, reader workflows, and re-read rules are established before the first patient is screened
