Independent subject-level data review for Sponsors.

When CRO reports, trackers, dashboards, and query metrics do not fully answer the question, TrialAssess helps Sponsor teams understand what is really happening inside the subject data.

A focused review layer — without adding noise.

Not an audit.
Not CRO replacement.
Not another dashboard.
Not blame.

A focused, Sponsor-side review that turns subject-level data concerns into structured evidence for action.

Book a Call

Confidential. No obligations.

When the trial feels “mostly under control” — but you still need clarity.

TrialAssess is designed for moments when your team needs evidence, not just status.

Sponsor teams often have reports, trackers, and status updates.

But the uncomfortable questions remain:

  • Are protocol deviations isolated or becoming a pattern?
  • Do subject journeys still make clinical sense?
  • Are endpoint data points credible in context?
  • Are safety follow-ups documented consistently?
  • Are closed queries actually resolving the issue?
  • Do we have enough evidence before escalating with the CRO?

TrialAssess reviews subject-level eCRF and non-eCRF data from an independent Sponsor-side perspective.

The goal is not to create blame.

The goal is to help you see whether the data supports confidence.

You receive a structured, practical output that helps your team:

  • Understand the current state of trial data integrity.
  • Identify risks to protocol adherence & GCP compliance.
  • Identify risks to subject safety documentation & endpoint credibility.
  • Separate isolated findings from recurring patterns.
  • Prepare fact-based CRO discussions.
  • Focus follow-up instead of creating random query noise.
  • Focus follow-up instead of creating random query noise.
  • Support inspection readiness and internal oversight confidence.

Start with a focused pilot review.

  • No new platform.
  • No unnecessary overhead.

Just an independent view of the subject data where your team needs more clarity.

A typical pilot can focus on:

  • selected subjects
  • selected sites
  • one study country
  • one critical data area
  • or one concern such as eligibility, visit adherence, endpoint consistency, safety follow-up, missing assessments, or unresolved query logic

The pilot includes:

1. Short alignment call
We discuss the trial context, current concerns, critical protocol elements, and the area where independent review would create the most value.

2. Protocol and eCRF familiarization
 I review the relevant protocol sections, eCRF structure, and study-specific review logic.

3. Independent subject-level review
 I review the agreed subject data for consistency, plausibility, protocol adherence, missing data, safety documentation, and overall subject journey coherence.

4. Structured Excel output
 You receive a practical workbook with a subject overview and finding list. Finding list can include e.g. eCRF location, finding description, suggested follow-up path, query-relevant wording & others.

5. Review call
 We walk through the findings, patterns, and possible next steps so your team can decide how to use the output internally and with the CRO.

Small. Practical. Value driven.

Schedule Your Introduction Call

Confidential. No obligations.