There’s a common misconception that only GLP-compliant Contract Research Organisations (CROs) can meaningfully support clinical development. In reality, many pharma and biotech teams rely on non-GLP laboratories for a wide range of translational and clinical-support studies—unlocking speed, flexibility, and actionable insights that accelerate decision-making.
While GLP compliance remains essential for pivotal non-clinical safety studies, numerous other studies that inform, enable, and de-risk clinical trials can be effectively conducted by non-GLP CROs operating under robust quality management systems. From mechanistic studies to complex in vitro models, non-GLP CROs offer a nimble, efficient way to generate high-quality, decision-enabling data without the overhead of full GLP compliance.
In this blog, we clarify what GLP entails and where it applies, outline the scope of work that non-GLP CROs can legitimately deliver to support clinical programmes, and highlight the strategic advantages of partnering with a non-GLP CRO like Cellomatics Biosciences—enabling clinical teams to leverage cutting-edge expertise, advanced models, and streamlined workflows to generate high-quality, decision-enabling data, accelerate programs, and make confident, data-driven decisions faster
What is GLP (Good Laboratory Practice)?
GLP is a formal quality framework governing non-clinical safety studies intended to support regulatory submissions for new drug (e.g. IND, CTA). GLP sets strict standards for how studies are planned, performed, monitored, recorded, archived, and reported, ensuring that the quality and integrity of resulting data used is acceptable to regulatory agencies. The primary purpose of GLP is to guarantee that toxicology, core safety pharmacology, and other pivotal non-clinical studies are credible and can underpin regulatory decision-making.
Importantly, beyond early preclinical work, many other translational activities that directly support clinical trials can also be executed in non-GLP labs.
What is the difference between a GLP CRO and a non-GLP CRO?
A GLP CRO is structured to perform pivotal non-clinical safety studies—such as toxicology and core safety studies—that will be submitted to regulatory authorities.
A non-GLP CRO (e.g., Cellomatics Biosciences) focuses on discovery, translational, and clinical-support studies where GLP compliance is not required. This approach provides greater speed, flexibility, and innovation while still delivering high-quality, decision-enabling data that accelerate clinical programs.
For a quick summary of non-GLP activities that directly support clinical studies, refer to Table A below.
What are the benefits of using a non GLP preclinical CRO for clinical trials?
- Cost effectiveness: Avoid GLP compliance overhead where it is not required; focus resources on scientific output and decision-quality data.
- Speed: Flexible SOPs allow faster method development and rapid iteration; especially critical before first-in-human studies (FIH) or during adaptive study design.
- Flexibility: Custom models, screening for novel biomarkers or exploratory pathways are easier to develop.
- Reduced risk: Early non-GLP feasibility tests allows refinement of strategies before investing in expensive GLP studies.
- Informed decision making: Generates high-quality data to support go/no-go decisions and de-risk the transition to pivotal GLP safety packages.
How can Cellomatics support clients with clinical trials?
Operating under an ISO 9001-certified Quality Management System, Cellomatics delivers high-quality biomarker analyses, immunology and efficacy assays, and mechanistic studies designed to support translational and clinical development. Our flexible, fit-for-purpose approach ensures actionable, decision-enabling data that de-risk programs and accelerate progress from the lab to the clinic.
Summary of our Services for Clinical Development:
- Custom assay development that are fit-for-purpose
- Biomarker & translational models (human cell-based systems) to confirm clinically measurable endpoints.
- Ex-vivo testing in primary human cells/PBMCs to anticipate human response and inform stratification.
- Stability, precision, and matrix comparability packages to ensure assay robustness on clinical samples.
- Multi-matrix readiness (serum, plasma, tissue lysates)
Why should clients use Cellomatics to support clinical trials?
Choosing a non-GLP CRO does not mean compromising on quality: it means applying the right standard at the right stage to generate fast, fit-for-purpose, decision-quality data that accelerates clinical programs.
- Faster turnaround than GLP providers, where GLP compliance is not required: By operating outside the constraints of full GLP compliance, Cellomatics can rapidly develop and execute studies, providing data in a fraction of the time. This agility is particularly valuable during early-phase translational studies or adaptive clinical trial designs, allowing teams to refine quickly and make timely, data-driven decisions.
- Custom immunology & inflammation expertise: Cellomatics offers deep, tailored expertise in immunology and inflammation, including bespoke assays, biomarker development, and mechanistic studies. Our scientists work closely with clients to design and implement studies that answer complex biological questions and provide insights that are directly relevant to clinical outcomes.
- Translational bridge from discovery to patient samples: Cellomatics provides seamless support across the translational spectrum—from early discovery models to patient-derived samples. This enables a clear, data-driven connection between preclinical findings and clinical endpoints, de-risking development programs and ensuring that insights gained in the lab are meaningful for clinical decision-making.
Quotes from clients that have used Cellomatics for clinicial trials
“Cellomatics Biosciences has been an invaluable partner in advancing our clinical trial programs. Their GLP-like preclinical services seamlessly combine scientific rigor with strict adherence to quality standards, ensuring the generation of robust, reproducible, and regulatory-compliant data. This high-quality data has been instrumental in guiding both our translational strategies and regulatory submissions. The Cellomatics team consistently demonstrates professionalism, deep technical expertise, responsiveness, and a collaborative approach, making them a trusted extension of our R&D efforts and a key contributor to our clinical development success.”
Dr Praveen Bommareddy, Senior Director Translational Research at Replimune Inc.
“Partnering with Cellomatics Biosciences has been instrumental in enhancing the efficiency and quality of our clinical study operations at Atlantia Clinical Trials. Their team combines scientific expertise with professionalism and flexibility, consistently helping us deliver high-quality results while optimising both timelines and costs. Cellomatics provides a comprehensive suite of standard and specialised analytical services, delivered promptly and with exceptional precision. Their collaborative, client-focused approach ensures tailored solutions that align perfectly with our project goals. Cellomatics has become a trusted and valued partner in driving the success of our clinical programmes.”
Jerry O’Shea, Senior Laboratory Technician at Atlantia Clinical Trials Ltd.
