GCP Compliant

Clinical Trial Cold Chain Management

Ensure the integrity of investigational drugs with comprehensive cold chain monitoring and compliance documentation throughout your clinical trials.

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Clinical trial cold chain

Clinical Trial-Specific Solutions

Specialized cold chain management designed for the unique requirements of clinical trials and investigational drug distribution.

GCP Compliance

Full Good Clinical Practice compliance with comprehensive documentation and audit trails.

Multi-site Management

Centralized monitoring and management across multiple clinical trial sites worldwide.

Global Distribution

Support for international clinical trials with region-specific regulatory compliance.

Chain of Custody

Complete chain of custody tracking for investigational drug products.

Regulatory Compliance Made Simple

Navigate complex regulatory requirements with confidence

FDA Requirements

  • 21 CFR Part 11 compliance
  • Electronic signatures
  • Audit trail integrity
  • Data integrity controls

EMA Guidelines

  • EU GDP compliance
  • Temperature mapping
  • Risk assessment
  • CAPA procedures

ICH Guidelines

  • Q1A stability testing
  • E6 GCP compliance
  • Documentation standards
  • Quality assurance

Clinical Trial Success

Trusted by clinical research organizations worldwide

95%
Trial success rate
50+
Countries supported
100%
Regulatory compliance

Frequently Asked Questions

How does TrueCold protect last-mile clinical trial shipments?

TrueCold orchestrates 'last-mile' delivery to clinical sites with zero-loss requirements by monitoring stability in real time and predicting thermal excursions before they occur. This protects investigational products on the most fragile leg of the journey.

Does TrueCold automate chain-of-custody for clinical supplies?

Yes. TrueCold provides automated chain-of-custody tracking across the clinical supply route, creating a continuous, audit-ready record of every handoff. This removes manual paperwork while keeping custody fully traceable.

Is TrueCold compliant with 21 CFR Part 11 and GDP for clinical trials?

TrueCold offers native support for 21 CFR Part 11, EU Annex 11, Global GDP, and GAMP 5, generating audit-ready electronic records automatically. This gives clinical and quality teams defensible compliance documentation for investigational products.

How does TrueCold prevent thermal excursions for investigational products?

TrueCold uses machine learning to predict thermal excursions before they happen by analyzing route weather, carrier performance, and historical lane data. Proactive alerts let teams intervene early to keep temperature-sensitive trial materials within spec.

Ensure Clinical Trial Success

Protect your investigational drugs and maintain regulatory compliance with our specialized clinical trial solutions.

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