We provide hands-on support for biotechs and sponsor teams when CROs fall short. Whether you need customized reconciliation, query oversight, or help preparing for inspection, our flexible service tiers are designed to match your timelines, systems, and documentation needs.

Flexible Clinical Trial Support Services

Tier 1: Customized Reporting & Oversight

Turn rigid CRO deliverables into sponsor-friendly insights. We translate mismatched data, flag cross-system issues, and provide dashboards tailored to your team’s visibility needs.

Typical Scope May Include:

  • Reconciliation of sample manifests, LIMS, and EDC (if applicable)

  • Custom discrepancy tracker with flags, resolution notes, and status

  • Sample-level context notes (“per batch” summaries)

  • Monthly summary report of trends, resolution rates, and recurring issues

Tier 3: Traceability & Inspection Readiness

We connect the dots across labs, systems, and vendors to ensure your data is complete, audit ready, and easy to defend during submission or inspection.

Typical Scope May Include:

  • Everything in Tier 2

  • Audit-ready traceability logs (full lifecycle: collection to final status)

  • Structured reconciliation of auxiliary documents (e.g., CoC logs, kit assignments, specimen receipts, deviation reports)

  • Monthly inspection prep summary reports (1–2 pages)

  • Optional weekly working call with sponsor QA or operations

Tier 2: Query Oversight & Sponsor Support

We track unresolved queries and vendor issues, highlight risks early, and support sponsor-side escalation so nothing gets missed before database lock.


Typical Scope May Include:

  • Everything in Tier 1

  • Support for up to 50 sample-related queries (review + draft comments)

  • Weekly discrepancy tracker with resolution and accountability tracking

  • Weekly sponsor check-in

Our services are built around your trial’s needs, not a fixed template.


We offer three levels of support that reflect common sponsor needs, from early data cleanup to high-stakes inspection prep. Each tier represents a typical engagement model,but every scope is tailored to match your timelines, data structure, and CRO coverage gaps.

Most clients begin with Tier 1 and scale support as their trial approaches database lock or regulatory milestones. Whether you need a single round of reconciliation or ongoing sponsor-side data oversight, we’ll scope a solution that fits.

Support Where Your CRO Stops Short


Need help with reconciliation, queries, or inspection prep? Select a service and we’ll follow up within one business day.