When a study slips, the first instinct is to blame the vendor or add more reporting. Neither tells you why. A short diagnostic can separate the causes before you change anything expensive.
Governance
Who decides what, and how long does a consequential decision take? Look at the last several escalations: when they were raised, who owned them and when they closed. Slow or circular decisions point to unclear decision rights, and they are as often on the sponsor side as the vendor side.
People and continuity
Compare the staff you were promised with the staff you have. Turnover, thin coverage of key roles and uneven review quality show up in the work before they show up in a status report. Ask the people doing the work, not only the account lead.
Sponsor inputs
Count the open items waiting for the sponsor: unresolved protocol questions, late approvals, shifting timelines and changed assumptions. A vendor cannot deliver against a moving target, and some of what looks like vendor delay is waiting.
Quality and data flow
Look at how clinical and data issues move from a site, through monitoring and data management, to a person who can decide. Are the same queries and deviations recurring? If so, the protocol, the CRF or the training may be the cause rather than the people.
Proportionate oversight
ICH E6(R3) emphasizes risk-based, proportionate quality management and the sponsor’s continuing responsibility for activities it delegates. That points toward a small set of indicators tied to the risks that matter for this study, reviewed regularly by someone able to act on them.
Public reference points
Related service: CRO & sponsor oversight.