The problem
Exhaustive source data verification is expensive and finds the wrong things.
Verifying every field against source is the most costly activity in a study and one of the least productive. It reliably catches transcription errors and reliably misses the failures that matter: a site interpreting eligibility loosely, a consent process drifting, a device stored outside range.
Regulators moved away from that model years ago toward risk-based oversight. Many sponsors follow the guidance on paper and still run the old model in practice, because it is what the budget was built on.
Our model was built for risk-based from the start. Monitors with therapeutic depth work alongside a central function watching the data continuously between visits.
Talk to a specialist
Tell us the problem. A specialist replies, not a form robot.
What we do
How we monitor.
Central monitoring
Continuous review of the data between visits, flagging trends and outliers in near real time.
Risk-based site visits
Frequency and depth driven by site risk rather than a fixed calendar.
Targeted SDV
Critical data and safety endpoints verified properly; everything else sampled.
Protocol deviation trends
Patterns identified across sites rather than logged individually.
Site coaching
Findings turned into corrective behaviour rather than a report.
Inspection support
Evidence that the monitoring plan was followed, not just written.
For consultants
Roles we place in monitoring.
Monitoring is where we place most often. Contract CRAs move frequently and we would rather know you before the next move.
- CRA I, II and Senior CRAs
- In-house and Remote CRAs
- Central Monitoring Specialists
- Lead and Regional CRAs
- Risk-based monitoring specialists
- Site management associates
Proof
Between visits
When most real signals appear, and when nobody is usually looking.
Client testimonials for this discipline are being collected and will appear here once approved in writing by the clients concerned.
Questions
Questions we get asked.
Do you provide monitors or run the whole function?
Both. Individual CRAs are the most common request; some clients hand us the function with a lead and central monitoring behind it.
Is risk-based monitoring accepted by regulators?
It is the expectation rather than a concession, provided the risk assessment is documented and the plan is actually followed.
Can you monitor studies you did not start?
Yes. Taking over mid-study is normal and starts with a review of what the previous monitoring actually covered.
How much travel is involved for consultants?
Varies by role. In-house and central monitoring roles involve little or none, which matters to a lot of experienced CRAs.
Do you cover sites outside the United States?
Our placements are US-based. For multinational programmes we work with sponsor and partner arrangements for other regions.
Related
Where to go next.
Talk to someone who has done this.
Hiring for it, or looking for the work. Either conversation is welcome.