Clinical

ICH E6(R3) GCP Compliance

ICH E6(R3) modernizes Good Clinical Practice with quality-by-design, critical-to-quality factors, and proportionate risk-based approaches. Viltis helps sponsors and CROs interpret E6(R3), update quali…

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Practice areaClinical
Typical needCapability support for regulated programs
EngagementConsulting, augmentation, or hybrid
Related pathClinical

The client situation

When organizations typically need this capability.
  • Updating SOPs and quality systems for E6(R3)
  • Inspectable trial quality gaps
  • Decentralized or pragmatic trial quality models
  • Vendor GCP oversight improvements

How Viltis helps

Structured support, end to end

  1. 01

    Step 1

    E6(R3) impact assessments

  2. 02

    Step 2

    QMS and SOP updates

  3. 03

    Step 3

    Risk-based quality planning

  4. 04

    Step 4

    Training and inspection preparation

ICH E6(R3) modernizes Good Clinical Practice with quality-by-design, critical-to-quality factors, and proportionate risk-based approaches. Viltis helps sponsors and CROs interpret E6(R3), update quality systems, and operationalize GCP expectations across study designs including decentralized elements.

Typical deliverables

What engagement can produce

Gap analysis vs E6(R3)

SOP upgrade package

CQ risk frameworks

Training decks

FAQ

Common questions

Is E6(R3) only for sponsors?

Sponsors, CROs, and sites all feel the impact. Viltis supports the ecosystem with proportionate quality frameworks.

Related proof

Manufacturing, Quality and Process Team

Recommissioning and qualifying a manufacturing site to produce COVID-19 test kits at scale.

Read the case study →

Viltis provides consulting and resourcing for compliance readiness and operational support. We do not issue certifications or act as an accredited certification body.

Need support with ICH E6(R3) GCP Compliance?

Discuss this requirement with our team - scope, timeline, and delivery model.

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