Quality Management Software for CROs and Clinical | Kintavo
DEVELOPMENT, MANUFACTURING & COMMERCIALIZATION

CROs

GCP-aligned quality and document control across multi-site, multi-sponsor clinical research operations.

GCP ICH E6 (R3) Multi-sponsor
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THE PROBLEM

Sponsors Now Audit Your QMS, Not Just Your SOPs.

ICH E6 (R3) shifted the ground under CROs: quality management is an explicit, risk-based system expectation — issues managed, root causes analyzed, CAPAs verified — not a binder of SOPs and a training log. Sponsor auditors and regulators alike now ask systems questions: how do you detect issues across studies, how do you escalate, how do you know your fixes worked?

Most CROs answer from a patchwork: CAPA in spreadsheets, SOPs on SharePoint, training in an LMS that does not know when an SOP changed. Every sponsor audit re-exposes the same seams.

REGULATORY REQUIREMENTS

What ICH E6 (R3) and GCP Require From CRO Quality Systems

E6 (R3) requires a quality management system proportionate to risk: processes defined, issues identified and escalated, root cause analysis where warranted, and corrective actions with effectiveness. Part 11 governs the electronic records; sponsor quality agreements add per-sponsor notification and oversight duties. ISO 9001 certification — increasingly a bid requirement — layers management review and internal audit on top.

Kintavo runs the QMS the framework describes: issue management with escalation rules, CAPA with verified effectiveness, SOPs linked to training, and sponsor-scoped reporting — one system across studies and sites.

WHAT AUDITORS LOOK FOR
Issues logged per study with no cross-study trending — the systemic signal nobody assembled.
CAPAs closed without effectiveness evidence.
SOP revisions that outran training — staff working under procedures they never saw.
Sponsor notification obligations met late or undocumented.
WHAT KINTAVO REPLACES
Issues in study-specific trackers → One issue system, trended across studies
CAPA in a spreadsheet → Root-caused CAPA with verified effectiveness
SOPs on SharePoint → Controlled documents with training linkage
Training in a disconnected LMS → Revision-triggered assignments, role-based
Audit prep per sponsor → Sponsor-scoped evidence, always current
CORE CAPABILITIES

The QMS E6 (R3) Describes, Running.

Issue Management
Structured intake across studies and sites, severity rules, escalation — and the cross-study trending that finds systemic signals.
CAPA Management
Root cause with evidence, owned actions, effectiveness verified before closure — the systems answer sponsors now ask for.
Document Control
SOPs versioned and approved, with revision-triggered training before staff work under the new version.
Training Management
Role-based curricula across functions and sites, current the day the auditor samples.
Audit & Inspection Support
Internal audits on schedule, sponsor audits and regulatory inspections handled with scoped, live evidence.
Sponsor-Scoped Reporting
Quality metrics and notifications per sponsor agreement — generated from live data.
WHAT IT LOOKS LIKE IN PRACTICE

A sponsor auditor opens with the systems question: how does the CRO detect recurring issues across studies? The quality director runs the trend view — protocol deviation categories across eleven active studies, one category flagged, an open CAPA linked. The auditor follows it: root cause, actions, and a 90-day effectiveness check with data. The finding count is zero; the bid team hears about it within the week.

EVIDENCE, NOT CLAIMS

The Systems Answer, on Screen.

"How do you know your fixes worked?" — the CAPA shows its effectiveness check: criteria, interval, data, signature. E6 (R3) questions are answered by records, not by narrative.

Cross-record activity trending — the systemic signal view
SHOWN WITH SAMPLE DATA. YOUR NUMBERS APPEAR THE DAY YOU CONNECT YOUR SYSTEM.

Configured for your rules from day one.

GCP
ICH E6 (R3) aligned
SOPs, training, and oversight built for the risk-based monitoring era.
MULTI-SITE
Every site, one system
Consistent quality processes across geographies with local flexibility where regulations differ.
SPONSORS
Sponsor-ready evidence
Qualification packets and audit responses assembled from live records, not email archaeology.
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"It was a no-brainer for us to implement Kintavo."
National Blood Collaborative Blood solutions · Trusted shared
MOST USED BY CROS TEAMS
Document Control → Training Management → Audit Management → Deviation Management → Workflow Builder →
QUESTIONS & ANSWERS

CROs FAQ

Does Kintavo support ICH E6 (R3) quality management requirements?
The R3 expectations — risk-proportionate processes, issue management, root cause analysis, CAPA with effectiveness — run as connected workflows with the records to prove them.
Can issues be trended across studies?
Yes — one issue system across studies and sites, with category and root-cause trending that surfaces systemic signals sponsors expect you to find first.
Is Kintavo Part 11 compliant for clinical quality records?
Yes — electronic signatures with re-authentication, append-only audit trails, and role-based access, with validation documentation included.
Can sponsors get visibility into our quality system?
Scoped, if you choose — per-sponsor views and metric reports drawn from live data, honoring each quality agreement’s terms.

See Kintavo configured for CROs.

Bring your real pain points. We'll show you exactly how it solves them — in your regulatory language.

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