Industries · Contract research organizations

Sponsor B audits Study 03.It sees Study 03, and only that.

Built for CROs running simultaneous studies for multiple sponsors, where each sponsor audits your quality system independently, and every protocol deviation, CAPA closure, and trial master file has to stay inspection-ready per study and per sponsor at any time.

Built for GCP-regulated clinical research teams

  • ICH E6(R2) GCP
  • 21 CFR Part 11
  • 21 CFR 50 / 56
  • eTMF
  • ALCOA+

The decision lives in the thread, not the eTMF entry.

Incumbents track deviation and document status. Unifize reconstructs the decision trace across every function a protocol deviation touched, segregated by study and by sponsor: the reasoning an inspector or a sponsor auditor actually asks for.

When the inspector or the sponsor auditor is in the room, someone reconstructs it.

The reconstruction always lands on someone. Find your seat, and see what you own when the trace has to hold up at an FDA BIMO inspection and every sponsor audit.

Clinical Quality

Every protocol deviation and CAPA decision stays reconstructable and segregated by study and by sponsor.

See the quality solution →

Clinical Operations

Deviations, queries, and dispositions move on one accountable thread across simultaneous studies.

Sponsor & Regulatory Liaison

The audit response, safety report, and sponsor oversight trail stays current and traceable per sponsor.

CSV & Data Integrity

Audit trails and electronic signatures are held to ALCOA+ and the system ships with a 21 CFR Part 11 validation package.

How it stays validated ↓

Study & Project Management

Study startup, monitoring, and close-out decisions move with their rationale sealed to the record per study.

Deviations, safety, eTMF, sponsors. One decision trace.

Each runs with GCP built in, segregated per study and per sponsor. Start with the one that costs you most.

Clinical Quality

From the protocol deviation to CAPA effectiveness, presentable per sponsor.

  • Protocol Deviation Management
  • CAPA & Effectiveness
  • Audit Finding Response
  • Internal Audit
See the quality solution →

Pharmacovigilance & Safety Reporting

Serious adverse events triaged against their expedited-reporting clock, including the check a missed procedure forces.

  • SAE / SUSAR Reporting
  • Pharmacovigilance Case Management

eTMF & Document Control

The trial master file kept inspection-ready, not assembled the week before.

  • eTMF Completeness & Inspection Readiness
  • Document Control
  • Clinical Study Report Governance

Sponsor & Audit Management

Every sponsor audits you independently. Each sees only its own studies.

  • Sponsor Audit Response
  • Sponsor Oversight

Built to sit beside your eTMF, and to survive the FDA inspection and every sponsor audit that assesses it.

  • Coexistence, not replacement

    Unifize sits alongside the eTMF, CTMS, QMS, and EDC you already run, including a sponsor-mandated Veeva Vault. It replaces the ungoverned channels where the decision trace goes missing, and the thread structure segregates evidence per study and per sponsor.

  • Part 11 and ALCOA+ by default

    Every approval is captured as an attributable, time-stamped electronic signature, so the decision trace is the audit trail: ALCOA+ by construction, and the 21 CFR Part 11 validation package (IQ / OQ / PQ) that sponsors require is ready for procurement, not reconstructed after the fact.

  • Your sponsor's and inspector's questions, answered directly

    Protocol-deviation and CAPA closure, per-sponsor data segregation, audit-trail integrity, and eTMF inspection readiness are walked through with your team, and built to survive the FDA BIMO inspection and every independent sponsor audit.

The moments that start a clock you don't control.

Statutory and sponsor deadlines, not internal outcomes. Each one routes to the process that answers it and the team that owns the response.

Sponsor audit failure risking MSA termination

Routes to Sponsor Audit Response · owned by Clinical Quality

eTMF inspection-readiness gap before a monitoring visit or data lock

Routes to eTMF Completeness & Inspection Readiness · owned by Study & Project Management

FDA Form 483 after a BIMO inspection

Routes to CAPA & Effectiveness · owned by Clinical Quality

The cost is real. It just never lands on a line you can see.

Coordination tax, per company per year

$0.2Mto$1.9M

Paid in chasing, handoffs and rework, one coordination event at a time. No budget line carries it, so nobody owns it. Modeled across 18 companies and 216K employees in the segment.

Coordination eventWhat’s at risk
  • Protocol deviation → CAPADEV-2087Clinical Qualityweeks of cycle time; a 483 if it ages
  • Sponsor audit responseSponsor B auditClinical QualityMSA termination; adjacent sponsors pulling pipeline
  • SAE / SUSAR expedited reportStudy 03 safety checkSponsor & Regulatory Liaisona missed expedited-reporting clock
  • eTMF inspection readinessAmendment 2 trainingStudy & Project Managementan inspection-readiness gap; a monitoring finding
  • Data / database lockStudy 03 lockClinical Operationsa slipped lock; a delayed clinical study report
Every instance, every team. None of it on a budget line.

Incumbents track the eTMF entry. Unifize reconstructs the decision, per study and per sponsor.

Pick a protocol deviation or CAPA you could not replay at the last BIMO inspection or sponsor audit. We will reconstruct it live.