Early-phase clinical trials that help you decide sooner
Need stronger early evidence before your molecule moves into larger, costlier studies?
SGS designs and conducts early-phase clinical trials that support the assessment of safety, PK, PD, biomarkers and proof-of-concept with speed, control and scientific focus.
Purpose-built CPU in Belgium
Our state-of-the-art clinical pharmacology unit offers 110 beds, high-care and quarantine units on the Antwerp University Hospital campus, with access to specialist infrastructure.
Regulatory speed
On-site GMP IMP support
Our integrated GMP production facility supports IMP manufacturing, packaging, (re-)labeling, EU import, QP release and rapid coordination with the clinical team.
Access to Belgium’s competitive EU CTR pathway for early-phase studies, with SGS guidance on local authority, ethics and site readiness.
Digital data capture and recruitment
Our eSource setup and digital recruitment platform support efficient volunteer screening, direct data capture, barcode-driven sample management, source-level monitoring and faster query resolution.
Built for early-phase complexity
Ready to de-risk your early-phase program?
In early-phase development, the objective is not simply to generate data, but to answer the right questions early. Depending on the model used, this may involve demonstrating proof of concept or generating early efficacy signals to guide development decisions.
Jelle Klein
Medical Director, SGS
Head of Development, Kaerus Bioscience
Marc Ceusters
We had a molecule and a high-level plan, but we needed someone who could challenge our thinking, shape the design and run the full study.
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How we can support you
Sharper early-phase protocol design
Build an early-phase strategy that addresses the right scientific questions early, supported by 40+ years of clinical pharmacology experience.
Connected clinical execution
Coordinate recruitment, screening, IMP supply, dosing, monitoring, sampling and follow-up through an integrated CPU and connected clinical sites.
Complex readouts and procedures
Manage intensive sampling and specialized procedures, including biomarkers, PBMCs, CSF, flow cytometry, imaging, telemetry and other specialized assessments in a controlled early-phase setting.
Clinical research in Europe is changing. Sponsors face more complex protocols, tighter timelines and growing pressure to make early development more efficient. That makes an integrated early-phase setup more valuable.
SGS supports Phase I and Phase IIa clinical pharmacology trials in healthy volunteers, special populations and patients. From first-in-human and adaptive protocols to complex sampling, sample handling, bioanalysis, GMP IMP support and data capture, we help you generate decision-enabling evidence under one coordinated operational setup.
De-risk your next early-phase decision
Advanced sample handling
Dedicated teams manage complex biological sample collection, handling and processing, including blood, urine, feces, CSF and PBMCs in accordance with protocol and lab manual specifications.
Bioanalytical and safety labs
Clinical conduct is directly connected with bioanalytical and safety laboratory services, in cluding cytokine and biomarker assays, supporting aligned sample logistics and timely data availability.
First-in-human studies
Studies that support safety and tolerability assessment, characterization of exposure-response relationship, dose range exploration, interaction risk, formulation decisions and metabolism insights. Conduct SAD, MAD, sentinel dosing, dose escalation, safety monitoring and PK/PD assessments in a controlled early-phase setting.
Combined and adaptive early-phase trial designs
Combine FIH study parts such as SAD, MAD, food effect, BA/BE, DDI, TQT, ADME and age cohorts into one adaptive design to improve timelines, operational efficiency and data continuity.
Human challenge trials
Design and conduct CHIM studies with established challenge models, dedicated infrastructure to asses early efficacy signals and mechanical responses under controlled conditions.
Phase IIa and patient proof-of-concept studies
Test early signs of activity in hybrid or defined patient populations, supporting candidate selection and subsequent development decisions before progressing into larger, more resource-intensive trials.
Study types we can support
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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.
