We are delighted to announce the reintroduction of human ADME (Adsorption, Distribution, Metabolism and Excretion) studies using ¹⁴C-radiolabeled investigational products at our clinical pharmacology unit in Antwerp.
The resumption of human ADME studies follows formal approval from the Belgian Federal Agency for Nuclear Control (FANC) to reinstate this highly specialized capability within our European early-phase clinical research portfolio, building on our extensive legacy in radiolabeled clinical research. Formerly, we conducted ¹⁴C human ADME studies at our former Stuivenberg clinical pharmacology site and through our bioanalysis laboratory in Wavre. Following the transition of clinical activities into the new, state-of-the-art clinical pharmacology unit in Antwerp, our specialist teams implemented a phased approach to re-establishing specialized capabilities.
With the completion of all regulatory, radiological and operational preparations, the Antwerp unit is now fully qualified to conduct human ¹⁴C ADME studies. FANC approval confirms that the facility meets all required standards for radiation safety, environmental protection and compliant clinical execution.
Human ADME studies provide an integrated assessment of how an investigational drug behaves in the human body, characterizing how it is absorbed, distributed, metabolized and eliminated. These studies enable the identification and quantification of circulating metabolites, elucidate metabolic pathways, and provide insight into the relative contributions of renal, biliary and fecal routes of excretion.
In early development, human ADME data are critical for guiding dose selection, assessing the need for dedicated drug-drug interaction or organ impairment studies, and informing regulatory strategy. The resulting data supports informed decision-making before progressing to larger patient trials, de-risking later-stage development.
While investment in biologics has increased over the past decade, small-molecule drug development remains a key focus area across pharma and biotech pipelines. At the same time, the number of European sites equipped to conduct complex human ADME trials has declined due to stringent infrastructure, operational and radiological compliance requirements.
This limited availability, combined with sustained demand for high-quality disposition data, has renewed the strategic importance of human ADME studies. A clear understanding of human metabolic profiles remains essential for regulatory submissions and for mitigating late-stage attrition.
Wim Verreth, Pharma – Head of Business Development and Support, SGS said: “SGS is delighted to have gained FANC approval, giving us the green light to re-commence ADME trials and, most critically, help meet the rising demand for early-phase clinical studies.
“As one of the few European CROs able to deliver complex, end-to-end human ADME programs, this will be welcome news for pharmaceutical and biotech sponsors in need of high-quality, regulator-accepted disposition data at a critical stage of their drug development journey.”
In reinstating human ADME to our portfolio, we are strengthening our ability to support drug development programmes with critical early clinical data. This enhanced capability also enables the delivery of modern microtracer studies combined with accelerator mass spectrometry (AMS) which enables ADME characterization using ultra-low levels of radioactivity, significantly reducing risk to healthy volunteers while accelerating go/no go decision making.
Our integrated service offering includes scientific consultancy for study design, clinical conduct, management of radiolabeled materials, radiological and regulatory compliance, and partnerships for isotope labeling and ultra-sensitive bioanalysis. This end-to-end capability gives sponsors a streamlined, compliant, and scientifically robust pathway to obtain essential human ADME data with greater efficiency and reduced operational complexity.
SGS is the world’s leading Testing, Inspection and Certification company. We operate a network of over 2,500 laboratories and business facilities across 115 countries, supported by a team of over 100,000 dedicated professionals. With more than 145 years of service excellence, we combine the precision and accuracy that define Swiss companies to help organizations achieve the highest standards of quality, compliance and sustainability.
Our brand promise – when you need to be sure – underscores our commitment to trust, integrity and reliability, enabling businesses to thrive with confidence. We proudly deliver our expert services through the SGS name and a portfolio of trusted specialized brands, including Applied Technical Services, Brightsight, Bluesign and Nutrasource.
SGS is publicly traded on the SIX Swiss Exchange under the ticker symbol SGSN (ISIN CH1256740924, Reuters SGSN.S, Bloomberg SGSN SW).
