Clinical trial monitoring services
Risk-based, centralised and on-site monitoring by experienced CRAs, in full or partial service models.
The problem we solve
Source data verification on everything is neither affordable nor what regulators ask for.
Since ICH E6(R2) the expectation is a risk-based approach: identify what could hurt patient safety or data integrity, monitor that closely, and stop spending visits on low-risk fields. Many studies still run the old way because nobody has time to redesign the plan.
Vakula provides the monitoring plan, the central monitoring analytics and the CRAs to execute it, as a full monitoring service or to supplement your team.
Tell us what you need
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What we do
Trial Monitoring capabilities
Risk-based monitoring
Risk assessment, key risk indicators, thresholds and a monitoring plan that targets what matters.
Centralised monitoring
Remote data review, statistical outlier detection and site performance dashboards.
On-site monitoring
Experienced CRAs for initiation, interim and close-out visits with timely, complete reports.
Adaptive monitoring
Visit frequency and scope adjusted as site risk changes, with documented rationale.
Patient-centric monitoring
Approaches that reduce site and patient burden while protecting data quality.
Monitoring oversight
Report review, CAPA tracking and sponsor oversight documentation.
How an engagement runs
What happens after you contact us
Intake call
A consultant who works in this function takes the brief: scope, systems, regulatory context, timeline and budget band. Same day where possible.
Proposal and people
Within a few business days you get a written scope or a shortlist of named consultants with availability and rates. No generic CVs.
Kick-off under a clear SOW
Deliverables, acceptance criteria, reporting cadence and escalation path are agreed in writing before work starts.
Delivery with oversight
A Vakula engagement lead stays accountable for quality and continuity, including cover if a consultant rolls off.
Questions
Before the first call
Can you take over monitoring mid-study?
Yes, with a documented transition plan covering site hand-over, open actions and report backlog.
Where are your CRAs?
Primarily US-based, regionally assigned to limit travel time and cost.
Do you provide the central monitoring tooling?
We work in the sponsor's or CRO's platform where one exists and can propose options where it does not.
How do you report?
A monthly monitoring dashboard and visit-report metrics agreed in the statement of work.
Related
Adjacent services
Start with one requirement.
Send us a role, a scope or a problem. We come back with a plan and a named consultant, not a sales deck.