Monitoring you can actually trust
Risk-Based Monitoring, Built Around Your Protocol.
Effective monitoring gives a sponsor an accurate view of what is happening at the site — not simply a record that a visit occurred.
Our monitoring approach is risk-based, documented and focused on the processes and data that matter most to participant safety and trial reliability.
On-site. Remote. Hybrid. Your call.
Monitoring services
- Site qualification and initiation support where included in scope
- On-site, remote and hybrid monitoring approaches
- Risk-based monitoring plans and protocol-specific monitoring tools
- Source-data review and verification levels defined by sponsor requirements and study risk
- Essential-document and investigator-site-file review
- Protocol deviation identification, documentation and escalation
- Clear monitoring reports with assigned follow-up and closure tracking
- CAPA support and effectiveness follow-up where applicable
Monitoring capacity
Monitoring resource is scoped per study rather than assumed. At feasibility we confirm the number of sites, expected visit frequency and travel requirements against available monitoring capacity, and we will say so if a study requires more coverage than we can responsibly commit. Where a program needs additional capacity, we scale through qualified contract monitors working to our monitoring plan, procedures and oversight.
Affiliated sites are not a lower-control environment
When MDTrials CRO monitors a site managed by MDTrials Sites, the affiliation is disclosed and the monitoring plan is not reduced because of the relationship. Findings follow the same documented escalation and closure process used elsewhere. Study responsibilities are assigned so that CRO oversight and site operations are not performed by the same individual on the same study.
A sponsor may require independent third-party monitoring at an affiliated site. Where that arrangement is selected, MDTrials will support the handoff and provide the access needed for the independent monitor to perform the assigned work.
Frequent Questions
- What does risk-based monitoring mean under ICH E6(R3)?It means concentrating monitoring effort where the risk to participant safety and data reliability is greatest, rather than applying the same intensity everywhere. In practice that means identifying factors critical to quality at study design, setting source data verification levels accordingly, and adjusting as the study generates information.
- Do you offer functional monitoring alongside our existing CRO?Yes. Monitoring can be contracted as standalone functional support alongside your existing CRO or internal clinical-operations team. The monitoring plan, site coverage and reporting model are agreed with the sponsor or prime CRO before work begins.
- Can we require third-party monitoring at your affiliated sites?Yes, at your sole election. We will support the handoff and provide the access the independent monitor needs.
CONTACT US
A published capability map removes the guesswork, so feasibility conversations start from an accurate scope, not assumptions.