Human ADME studies
Need to understand how your drug behaves in humans before moving into costly patient trials or preparing for regulatory approval?
SGS designs and conducts human ADME and ¹⁴C mass balance studies to help pharma and biotech teams understand absorption, distribution, metabolism and excretion early in clinical development, to guide the next development decision.
One European hub
Work with one of the few European CROs able to deliver complex, end-to-end human ADME programs. With safety, compliance, monitoring and waste handling fully integrated across the study lifecycle.
Compliant ¹⁴C setup
Microtracer options
Use AMS-based microtracer designs when you need very low radioactivity, reduced volunteer exposure and generation of human ADMA data earlier in development.
Run human ¹⁴C ADME studies through our state-of-the-art clinical pharmacology unit in Antwerp, supported by the required radiological approval and operational compliance framework.
Human data, not assumptions
Confirm whether preclinical ADME expectations translate to humans, supporting data-driven decisions at different stages of development.
When you need to be sure
Secure European capacity
If hADME is on your development roadmap, we’re happy to discuss study design, timeines and fit for your program.
Jelle Klein
Medical Director, SGS
Director Clinical Pharmacology Unit
SGS
Wim Verreth
Human ADME data remains a regulatory cornerstone in early development.
As specialized European capacity becomes more limited, having an established and compliant ¹⁴C setup provides sponsors with a reliable route to generate these critical data.
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How we can support you
Study design consultancy
Define the right hADME approach from the start, including dose route, sampling strategy and key development questions.
Clinical conduct
Run early-phase ADME trials in healthy volunteers, with intensive sample collection to quantify recovery, clearance and excretion pathways, supported by closely coordinated downstream bioanalysis to maintain study momentum.
Microdosing and AMS coordination
Use microdosing-based ADME approaches supported by ultra-sensitive AMS bioanalysis analysis through qualified specialist partners.
Radiolabeled material management
We manage the clinical, radiological, safety and waste requirements associated with ¹⁴C investigational products, including coordination of radiolabeling and analytical workflows.
Regulatory and vendor coordination
Align study operations, specialist partners, logistics and regulatory compliance so your ADME study runs as a single coordinated program, with integrated timelines across investigational product supply, clinical conduct and bioanalytical data delivery.
Know the human disposition story
Human ADME studies characterize how an investigational drug behaves in humans, including metabolite identification, metabolic pathways and recovery of drug-related material.
They support development decisions at different stages: when performed early, they reduce uncertainty and inform clinical pharmacology strategy, when conducted later, they remain a regulatory requirement for submission and labeling.
Unexpected human metabolites can trigger extra studies and impact timelines, making early access to ADME data valuable for proactive planning. SGS supports both approaches through an integrated clinical, radiological and bioanalytical setup for ¹⁴C studies, enabling efficient sample processing and timely study progression.
Advanced sample handling
Dedicated lab teams handle samples such as blood, urine and feces under controlled conditions, according to protocol and lab manual requirements.
Specialized bioanalytical integration
We connect clinical conduct with specialized ¹⁴C bioanalytical services, with coordinated logistics enabling same-day processing and rapid turnaround. This supports efficient progression toward mass balance recovery, reducing the need for extended participant confinement and overall study duration.
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About SGS Clinical Research
We're a mid-sized, full-service CRO specialized in early-phase development and biometrics. We offer drug development consultancy, project management, monitoring, data management, statistics, medical writing, safety and regulatory services. We have our own clinical pharmacology unit in Belgium featuring a viral challenge facility and have access to patients through our site network with 400+ sites. Our key therapeutic areas include infectious diseases, vaccines, respiratory, dermatology and oncology.
Ellen Verhavert
Head of GMP Production Facility and QP, SGS