Global Expertise in Ethical Clinical Compliance

Our GCP auditing services ensure that your clinical trials comply with international ethical and regulatory standards. We assess investigator sites, sponsors, CROs, and systems involved in clinical development.

Good Clinical Practice (GCP)

Our highly experienced, trained and competent team of specialist GCP auditors has conducted thousands of audits in all therapeutic areas, according to international and national regulations, in over 100 countries. Continual positive client feedback is evidence of our professionalism and competency.

The conduct of GCP quality audits is becoming an increasingly challenging process, owing to the complexity of clinical trials and the location of investigator sites. Although the majority of sponsor organizations reside in Europe, the USA and Japan, their clinical trial sites are often located in Asia, Africa, South America, the Middle East and the Far East. Our experienced team is adept at dealing with the diverse cultures that they encounter.

Highly Experienced.
Professional. Global Reach.

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Assurance and confidence are values we live by, we understand they underpin your compliance activities.

FEATURED RESOURCES

For a deeper dive into the ICH E6(R3) guidelines, check out our latest expert insights.

WEBINAR

I'NI CONSULTING's webinar, "GCP ICH E6 R3 Unveiled: Navigating the Evolving Roles of Sponsors and CROs," provides invaluable insights into the evolving landscape of Good Clinical Practice (GCP) guidelines.

CASE STUDY

Our latest case study highlights how I'NI CONSULTING supported a leading pharmaceutical company in proactively identifying high-risk sites during a global Phase III oncology trial—aligning with ICH E6 (R3) guidelines.

GUIDE

In this free guide, we break down the most critical updates to ICH E6(R3)—and provide practical, inspection-ready strategies to help you stay compliant, audit-ready, and ahead of regulatory expectations.

I’NI CONSULTING CAN SUPPORT YOUR PROCESSES. WE PARTNER WITH YOUR ORGANIZATION TO CONDUCT FACILITY WALKTHROUGHS TO ASSIST IMPROVEMENTS THROUGHOUT THE COMPANY.

ARTICLES AND INSIGHTS FROM I'NI Consulting

RQA Course: A System Approach to Good Pharmacovigilance Practice

INI Consulting is proud to support the professional development of pharmacovigilance (PV) specialists across the industry through active participation in the RQA’s highly…

DIA 2025 Global Annual Meeting | Washington, DC

INI Consulting looks forward to attending the upcoming DIA Global Annual Meeting 2025 that will take place in Washington, DC from 15–19 June.

2025 European QA Virtual Conference

INI Consulting Consulting is proud to be a Silver Sponsor of the 2025 RQA European QA Virtual Conference, the must-attend event for quality assurance…

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