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Infectious disease and vaccine clinical research services from SGS – providing you with comprehensive scientific expertise and cross-disciplinary support.

Clinical therapeutic areas

Effective clinical research and drug development for infectious diseases requires interdisciplinary resources, support and state-of-the-art facilities. We provide over 35 years of experience, bringing infectious disease and vaccine compounds through the complete clinical development cycle. As an international mid-size CRO, we are recognized as the benchmark clinical research partner for quality, reliability, flexibility and customer care. With our comprehensive infectious disease clinical trial services, you can access clinical, laboratory and complementary services all under one roof – from stand-alone support to a complete service package.

Why choose infectious disease and vaccine clinical research services from SGS?

Access our extensive expertise

Our dedicated therapeutic project director has over 30 years of experience in infectious diseases and applies his expertise to your project, defining the best scientific approach for the compound’s development and the study execution. We have cultivated solid expertise in specific indications, including:

  • HIV: IMPs (non-inferiority), drug/drug interaction, formulation, AE studies
  • Hepatitis: drug and vaccine (therapeutic and preventative)
  • Viral challenge: influenza (H1N1 / H3N2), RSV and rhinovirus
  • TB: novel compounds, immunomodulators, vaccines

Our project director is supported by a complete team of clinical and biometrics project managers, key opinion leaders, and CRAs, all with backgrounds in therapeutic infectious diseases.

Benefit from our recognized influenza, HIV, hepatitis, tuberculosis and Ebola experience in early and late phase trials

We offer you wide-ranging experience in the field of virology and infectious diseases. Overall, we have:

  • Completed more than 400 infectious disease trials from Phase I to Phase IV for:
    • HVC /HIV/HBV
    • Fungal infections
    • Influenza
    • Tuberculosis
    • Respiratory Syncytial Virus (RSV)
    • Pseudomonas aeruginosa
    • Campylobacter jejuni
    • Chlamydia trachomatis
    • Helminths
    • Human rhinovirus
  • Contributed to three HIV products approved by the FDA (one designated as Fast Track) and EMEA
  • Collaborated on 278 infectious diseases studies, and participated in 71 Phase II-III studies in the last five years. In total, 24,762 patients were recruited across more than 1,900 sites in Europe (including Central and Eastern Europe (CEE)) and North America (US and Canada)

Achieve faster execution times for clinical trials with lower subject numbers

We conduct viral challenge studies at our dedicated 20-bed, Biosafety Level 2-Q compliant quarantine facility within our clinical pharmacology unit, to develop and evaluate new-generation vaccines and treatments for treating influenza, RSV, and other viruses.

Thanks to our human challenge testing model, you can consider new approaches outside of large-scale field trials. This offers you accelerated access to Proof of Concept (PoC), Mechanism of Action (MoA) and safety data, utilizing our extensive database of healthy volunteers, special populations, and patients. With this new approach, you benefit from faster execution times and lower subject numbers.

Enroll healthy volunteers and patients more quickly

We help you find healthy volunteers and patients, through our global referral network of physicians and SGS hospital-based clinical facilities (located in Belgium and Hungary). This enables you to secure quick and efficient access to the right infectious disease center. Our sites also provide you with consistent quality through adherence to our harmonized SOPs.

Gain therapeutic-specific project advice

We offer you advice and feedback on study planning, allowing for smoother execution and in-depth feasibility data based on a large investigator database.

A Range Of World-Leading Infectious Disease Clinical Research Services

Our services include:

  • Consultancy: such as preclinical and clinical data reviews, regulatory services for Investigational Medicinal Product Dossiers (IMPD), Investigational New Drug (IND) applications, Investigator Brochures (IB), and regulatory submission strategy input for Europe, US and many other countries throughout the world.
  • Clinical development planning: from target profile and product positioning to Phase I design and synopsis
  • Phase I-IV clinical trials
  • Biometrics services
  • Pharmacovigilance: we can assist with drug safety and post registration surveillance
  • Bioanalytical laboratory services: we offer biosafety and immuno cell-based assays, biomarkers (viral (Ab, PERT, RT-PCR, TCID50)), Pharmacokinetics (PK), Pharmacodynamics (PD) and safety blood panels

To discuss your infectious disease drug development program, contact us today.