Just in Time GCP

Business Consulting and ServicesPennsylvania, United States51-200 Employees

Just in Time GCP

Your Path to Inspection Confidence. Your Partner in Clinical Compliance.

For more than 20 years, Just in Time GCP has guided sponsors and life science organizations along their path to inspection readiness. We align people, processes, and technologies with Good Clinical Practice (GCP) and organizational goals—helping you run confident, inspection-ready studies that stand up to regulatory scrutiny.

Our team of more than 115 full-time clinical experts brings deep regulatory, operational, and systems knowledge to every engagement. From GCP gap assessments to TMF remediation, we deliver practical solutions rooted in experience—earned through participation in over 100 regulatory inspections.

We stay ahead of evolving regulations, technologies, and industry best practices so you can focus on the science while we ensure your foundation for compliance is strong.

Our Expertise:

Trial Master File (TMF) Assessment, Management & Remediation
Strengthen TMF completeness, quality, and timeliness as key risk signals for inspection readiness.

Clinical System Implementation & Optimization
Build fit-for-purpose, validated systems that support efficiency and oversight.

Roadmap to GCP Compliance
Translate ICH E6(R3) expectations into actionable strategies across your QMS, SOPs, and partners.

Inspection-Ready Confidence
Implement risk-proportionate oversight and continuous readiness—so you’re always inspection-ready.

Whether you need a quick assessment, immediate remediation, or a long-term compliance partner, Just in Time GCP is here to help you find your path forward—toward inspection confidence, operational clarity, and lasting compliance success.

🔗 justintimegcp.com/services

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