Reporting
Clinical Trial Reporting & Sponsor Study Assessment
ClariTria turns fragmented operational information into an independent sponsor-level view of study performance, emerging risk and areas requiring attention. Below: what we review, what you actually receive, a side-by-side example, and a sample illustrative dashboard.
Discuss Your StudyWhat ClariTria Reviews
We look beyond the headline status.
Enrollment
Are actual recruitment trends consistent with expectations?
Site Performance
Which sites are performing, drifting or showing warning signals?
CRO Reporting
Does the information being reported provide a complete picture of study performance?
Timelines
Are emerging operational issues likely to affect milestones?
Data & Quality Signals
Are available signals pointing toward potential operational or quality concerns?
Actions & Follow-Through
Are important issues being addressed and followed through?
That flow — Enrollment → Sites → CRO → Timelines → Data → Actions — is enough to produce a single, comparable number for every engagement: the ClariTria Study Health Assessment™.
We don't replace operational reporting. We make it more useful to the sponsor.
ClariTria turns fragmented operational information into an independent sponsor-level view of study performance, emerging risk and areas requiring attention.
ClariTria Study Health Score
Illustrative example — not based on a specific client study. Category weighting is calibrated to each engagement's protocol and risk profile.
What You Receive
What you actually receive.
Independent Study Assessment
A structured view of current study performance and emerging risk.
Operational Risk Summary
The issues that deserve attention now.
Trend Analysis
Where performance is improving, deteriorating or diverging from expectations.
Sponsor-Level Reporting
Clear findings without unnecessary operational noise.
Recommendations
Questions, areas for investigation and potential actions for sponsor consideration.
Ongoing Oversight
For recurring engagements, periodic independent assessments showing what has changed and what deserves attention.
What Independent Assessment Looks Like
CRO report vs. ClariTria review.
CRO Reports
“Enrollment remains within acceptable trajectory.”
ClariTria Review Identifies
- Recruitment concentrated in a small number of sites
- Several sites showing little or no meaningful recruitment
- Changes in screening-to-enrollment performance
- Delayed recruitment actions
- Increasing dependence on a small number of high-performing sites
Sponsor View
What is happening, why it may matter, what deserves investigation, what questions should be asked, and what actions may warrant consideration.
Illustrative example — not based on a specific client study.
Illustrative Dashboard — Advanced Sponsor Oversight
What a study under watch looks like.
A sample of the kind of picture ClariTria's independent assessment surfaces for a sponsor — reflecting the level of detail included under Advanced Sponsor Oversight.
Study Health
No open items are trending toward escalation. Routine monitoring continues on schedule.
- Site-level risk analysis
- 0 of 18 sites flagged high-risk
- Recruitment-risk analysis
- Enrollment evenly distributed across sites
- CRO action-plan follow-through
- 4 of 4 open items on schedule
- Escalated to sponsor this cycle
- 0 items
- Assessment cadence
- Bi-weekly, Advanced tier
3 open items are trending toward escalation if unaddressed — see flagged sites.
- Site-level risk analysis
- 3 of 18 sites flagged high-risk
- Recruitment-risk analysis
- Top 2 sites carry 61% of enrollment
- CRO action-plan follow-through
- 2 of 5 open items overdue
- Escalated to sponsor this cycle
- 1 item
- Assessment cadence
- Bi-weekly, Advanced tier
2 items have passed the sponsor's escalation threshold and require a decision this cycle.
- Site-level risk analysis
- 6 of 18 sites flagged high-risk
- Recruitment-risk analysis
- Top site carries 44% of enrollment; at risk if it stalls
- CRO action-plan follow-through
- 4 of 6 open items overdue, 2 unacknowledged
- Escalated to sponsor this cycle
- 2 items
- Assessment cadence
- Weekly, escalated review
Flagged for Sponsor Attention
- No sites currently flagged for sponsor attention.
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Site 07Enrollment
Zero enrollment for 3 weeks; IRB renewal still pending.
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Site 12CRO Action Plan
Corrective action from last cycle still open, 14 days past due.
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Site 03Escalation
Monitoring visit report overdue by 9 days — escalated to sponsor.
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Site 07Enrollment
Zero enrollment for 7 weeks; IRB renewal lapsed — recommend site closure review.
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Site 12CRO Action Plan
Two consecutive corrective actions missed; CRO has not acknowledged escalation.
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Site 15Data Quality
Query aging past 21 days on 11 open items across 3 forms.
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Site 03Escalation
Monitoring visit report overdue by 23 days — escalated to sponsor twice.