On Friday 13 March 2026, Jeanette Young, Laboratory Solutions & GCLP Team Lead at Pharmalys, delivered an insightful and engaging presentation at TASK HQ in South Africa. TASK is a global clinical research organisation with an in-house laboratory currently building on its established ISO 15189-accredited systems, to explore how GCLP principles could further enhance its ability to generate clinical trial-ready data. Jeanette was invited as a guest speaker during one of their routine Friday morning information sessions as it was the laboratory team’s turn to present, with eighty (80) people in attendance, both online and in the room.
Speaking on behalf of the GCLP Accreditation Scheme managed by Pharmalys, her talk “From Chaos to Compliance: GCLP Turning Lab Work into Quality Lab Work”, focused on strengthening quality systems within clinical research laboratories.
The session brought together onsite attendees and virtual participants, creating a dynamic environment for discussion, learning, and shared commitment to laboratory excellence.
GCLP vs. ISO 15189: Understanding the Difference
One of the standout components of Jeanette’s presentation was her clear comparison between GCLP and ISO 15189, two (2) respected quality frameworks often considered by laboratories involved in clinical research.
Jeanette highlighted that while both systems are robust, they serve different purposes, and it’s important for laboratories supporting clinical trials to choose the system that best aligns with their responsibilities:
ISO 15189
- Focused on general laboratory operations and diagnostic testing rather than the needs of GCP compliant clinical trials
- Widely recognised, it does not address the Good Clinical Practice (GCP) requirements but primarily supports healthcare diagnostics, not clinical research. Would need to supplement to be clinical trial-ready.
- More rigid, with a strong emphasis on routine diagnostic testing.
- More recognised in hospital and diagnostic lab settings.
GCLP
- Tailored for clinical trial sample analysis and data integrity in a GCP environment.
- Directly supports compliance with GCP and clinical trial protocols.
- Offers adaptable frameworks for diverse clinical trial settings and sponsor requirements.
- Widely accepted by sponsors and CROs for trial-related lab work.
This comparison helped emphasise why GCLP remains the most suitable framework for laboratories operating within the clinical research environment, particularly those generating data for clinical trials where sponsor oversight and regulatory alignment are essential.
Quality as a Mindset, not a Burden
Throughout her talk, Jeanette emphasised a fundamental principle: quality is not simply about compliance – it is a mindset.
Compliance, she explained, should never be reduced to a series of tick-box activities aimed at appeasing auditors. Instead, it forms the foundation upon which reliable science is built.
Every sample processed, every analytical run, and every documented process contributes to the trustworthiness and credibility of clinical research, and that is something that a laboratory must take pride in.
By applying excellence in providing clinical trial outcomes, the laboratory contributes to robust health data that ultimately benefits participants through improved health insights and treatment decisions.
A Shared Commitment to Excellence
Jeanette expressed her gratitude to the TASK team for their warm hospitality and active engagement throughout the session. The productive exchange of insights from both onsite and remote attendees reaffirmed the importance of collaborative learning in strengthening laboratory quality systems across the clinical research landscape.
For laboratories looking for more information on the GCLP Accreditation Scheme at Pharmalys, visit our website.
