Immunology and Inflammation CRO
Clinical Trial Expertise Across IMID
Industry-leading experience in immunology and inflammation clinical trials
Immune-mediated inflammatory diseases (IMID) are among the fastest-growing categories in biopharmaceutical development. From rheumatoid arthritis and systemic lupus erythematosus (SLE) to inflammatory bowel disease (IBD), atopic dermatitis and psoriasis, the pipeline for targeted therapies (including monoclonal antibodies, JAK inhibitors and bispecific antibodies) demands a CRO partner with the therapeutic depth, a global site network and operational precision to accelerate delivery without compromising data quality.
As a leading IMID CRO, Syneos Health brings together a global network of more than 3,500 investigative sites, therapeutically aligned clinical teams and validated endpoint management processes across the full spectrum of autoimmune and inflammatory disease clinical research.
Since 2020:
100+
studies
3,500+
sites
19K+
patients
Since 2020, we have supported more than 100 immunology and inflammation studies enrolling over 19,000 patients across indications from rheumatoid arthritis and lupus nephritis to ankylosing spondylitis, Crohn's disease and hidradenitis suppurativa.
Immunology Clinical Trial Site Selection and Global Network
Identifying and activating the right investigative sites is one of the most critical, and most difficult, factors in immunology clinical trial success. Syneos Health maintains a global network of more than 3,500 sites with proven immunology and inflammation experience, built over years of therapeutic alignment between our CRAs, project managers and the investigators they serve.
Long-standing site relationships are a competitive advantage in IMID trials. When our CRAs and project managers have worked with the same investigators across multiple studies, those sites consistently prioritize our sponsors' work translating directly to faster site activation timelines and higher protocol compliance rates.
Site selection for immunology and inflammation studies requires more than database queries. Whether you are targeting biologic-naïve rheumatoid arthritis patients, anti-dsDNA-positive lupus nephritis sub-populations or treatment-refractory Crohn's disease cohorts, our teams apply benchmark analyses, dedicated immunology feasibility surveys and continuous timeline verification to identify the countries and sites best positioned for your specific patient population.
Patient Recruitment for Autoimmune and IMID Clinical Trials
Effective patient recruitment for autoimmune clinical trials requires more than access to databases; it requires therapeutic fluency. Our globally distributed teams combine deep IMID patient population knowledge with regional standard-of-care expertise, allowing us to identify and screen the right patients across diverse geographies and healthcare systems.
This regional precision is especially important for indications with uneven patient distributions. Syneos Health has established dedicated expertise in recruiting difficult-to-enroll populations, including biologic-naïve rheumatoid arthritis patients, lupus nephritis patients requiring specific serological profiles, moderate-to-severe atopic dermatitis candidates, treatment-refractory Crohn's disease and ulcerative colitis cohorts and psoriatic arthritis patients on or off prior biologics.
Our immunology patient recruitment specialists maintain proprietary databases and multi-channel outreach strategies developed specifically for autoimmune and inflammatory disease trials. These strategies enable accurate targeting, accelerated screening and enrollment within protocol-defined timelines, a critical factor given the high screening failure rates common in indications like SLE and lupus nephritis.
Syneos Health's therapeutic experts contribute to immunology protocol design and review, identifying enrollment barriers, tightening inclusion/exclusion criteria, and recommending practical adaptations before the study starts. This upstream input reduces the likelihood of protocol amendments, which are disproportionately common in complex autoimmune indications and can add months to study timelines.
Data Quality and Endpoint Management in Inflammation Studies
Immune-mediated inflammatory diseases present some of the most complex endpoint challenges in clinical research. Conducting IMID clinical trials with integrity requires not just experience, but indication-specific infrastructure, from endpoint adjudication systems to site training programs calibrated to the subjectivity inherent in conditions like systemic lupus erythematosus, primary Sjögren’s disease (SjD), myositis and vasculitis.
- Complex endpoints (for example SLEDAI, BILAG, and CLASI in SLE, or ESSDAI in SjD) are highly prone to inter-rater and intra-rater variability. Syneos Health has developed comprehensive, indication-specific site and project team training programs, delivered through our Global Clinical Education and Strategic Programs team, with continuous updates reflecting evolving regulatory guidance and changes in the standard of care in IMID.
Our endpoint management infrastructure for immunology studies includes:
- Trial EAS™: Syneos Health's proprietary, web-based endpoint adjudication system that provides structured, continuous review by therapeutically aligned medical monitors. Designed specifically for high-subjectivity endpoints in autoimmune and inflammatory indications, Trial EAS™ reduces assessor variability and protects data integrity across multi-site, global trials.
- Continuous tool development from study design through endpoint management, ensuring our immunology clinical trial infrastructure keeps pace with evolving sponsor needs and regulatory expectations.
- Trusted Process®: Syneos Health's metrics-driven operating methodology, designed to accelerate study results delivery while guaranteeing data integrity and reducing operational risk and variability across all therapeutic areas, including immunology and inflammation clinical trials.
Immunology and Inflammation Indications We Support
Syneos Health has deep immunology CRO expertise across the full spectrum of immune-mediated inflammatory diseases (IMID). Our therapeutically aligned teams, investigative site network and endpoint management infrastructure support studies across the following autoimmune and inflammatory indications:
- Rheumatoid Arthritis (RA)
- Lupus Nephritis
- Atopic Dermatitis
- Ankylosing Spondylitis / axSpA
- Hidradenitis Suppurativa (HS)
- Myositis / Dermatomyositis
- Systemic Lupus Erythematosus (SLE)
- Psoriasis & Psoriatic Arthritis (PsA)
- Inflammatory Bowel Disease (IBD) — Crohn's Disease & Ulcerative Colitis
- Multiple Sclerosis (MS)
- Sjögren's Disease
- Uveitis (non-infectious)
Our modality experience spans monoclonal antibodies, bispecific antibodies, JAK inhibitors and small molecules, biosimilars and emerging modalities including cell and gene therapy in autoimmune disease contexts.
An immunology CRO (contract research organization) is a specialist clinical research partner that manages and executes clinical trials for biopharmaceutical companies developing treatments for immune-mediated and inflammatory conditions. Core services include study design and protocol optimization, global site selection and feasibility, patient recruitment and retention, clinical monitoring, endpoint adjudication, regulatory support and data management. Syneos Health's immunology CRO services are distinguished by our therapeutic alignment model in which CRAs, project managers and medical monitors are dedicated to immunology and inflammation across the full study lifecycle.
Trial EAS™ (Endpoint Adjudication System) is Syneos Health's proprietary, web-based platform that supports continuous endpoint review by therapeutically aligned medical monitors. In immunology studies, where composite endpoints such as DAS28 in rheumatoid arthritis and SLEDAI or BILAG in SLE are highly prone to assessor variability, Trial EAS™ provides a structured, validated framework for data quality oversight. This reduces operational variability and protects the integrity of endpoint data throughout the trial.
Syneos Health supports clinical trials across the full spectrum of immune-mediated inflammatory diseases (IMID), including rheumatoid arthritis, systemic lupus erythematosus (SLE), lupus nephritis, psoriasis, psoriatic arthritis, atopic dermatitis, ankylosing spondylitis, inflammatory bowel disease (Crohn's disease and ulcerative colitis), hidradenitis suppurativa, Sjögren's syndrome, myositis and non-infectious uveitis. Our global site network and therapeutically aligned teams support both early-phase and late-phase studies across these indications.
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