Full-Service Clinical Development for Immunology & Inflammation.

Advancing therapies across autoimmune and inflammatory diseases

Start Fast. Scale Seamlessly.

Immune-mediated inflammatory diseases span autoimmune, hematologic, renal, and respiratory conditions — each with unique diagnostic pathways, endpoint requirements, and patient populations that demand specialized expertise.

Learn about our Immunology and Inflammation service offerings

We start fast and scale seamlessly because our immunology and inflammation teams combine scientific rigor with operational creativity across four dedicated franchise areas:

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Autoimmune

IBD, Crohn’s, UC, RA, SLE, psoriasis, systemic sclerosis, immuno-neurology

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Hematology

Sickle cell disease, beta thalassemia, rare bleeding disorders, neutropenia

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Nephrology

Lupus nephritis, C3G, IgA nephropathy, hyperoxaluria, PKD, rare renal diseases

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Respiratory

Idiopathic pulmonary fibrosis (IPF), COPD, asthma, chronic cough, cystic fibrosis, bronchiectasi

Respiratory endpoint quality that exceeds industry norms (94% acceptable vs. 91% benchmark). Early flare detection strategies that improve eligibility and reduce dropout in nephrology. Proven site activation across Africa, Middle East, LATAM, and South Asia for hematology recruitment. We provide consistent, senior-supported delivery teams from bid to database lock.

We deliver complex Immunology and Inflammation trials with scientific care, global reach, and operational creativity, ensuring high-quality data, continuity of teams, and adaptive problem-solving.

Talk to an Immunology and Inflammation Expert

Immunology & Inflammation Challenges We Solve Every Day

Across Autoimmune, Hematology, Nephrology, & Respiratory Programs.

Endpoint Mastery & Diagnostic Precision

We strengthen immunology and inflammation protocols through senior scientific and medical review, ensuring feasibility, alignment with clinical practice, and regulatory confidence. Our respiratory teams deliver ATS/ERS-aligned spirometry training with endpoint quality that consistently exceeds industry benchmarks. In nephrology, central pathology review increases diagnostic precision, ensuring patients entering your trial are truly aligned to the target indication.

Creative Problem-Solving for Complex Immunology & Inflammation Enrollment

Immunology and inflammation trials present unique enrollment barriers, from flare-dependent eligibility in lupus nephritis to complex diagnostic pathways in rare hematologic conditions. We resolve them through high-impact operational strategies: early flare detection using patient dipstick monitoring that improves eligibility and reduces ER-driven dropout. Our autoimmune feasibility refinement that ensures protocol and endpoint practicality, and our respiratory endpoint precision that makes every data point count.

We Deliver Immunology & Inflammation Studies Where the Patients Are

Many immunology & inflammation patients, particularly in hematology and rare renal diseases, reside in regions that require local knowledge, trusted regional partners, and experience navigating cultural, regulatory, and logistical realities. We have proven delivery across MENA, Africa, LATAM, and South Asia, including culturally sensitive patient-mobility management for gender travel norms and family logistics. Our global site networks for respiratory and autoimmune complex endpoints span North America, Europe, LATAM, and Asia-Pacific.

The Team We Promise is the Team You Get

Our immunology & inflammation teams feature stable PMs, medically informed CRAs, and senior leadership access throughout delivery. Agile governance ensures rapid decision-making without layers of bureaucracy. The people at your bid defense are the people who run your trial.

Start Fast. Scale Seamlessly. Full Immunology & Inflammation Development Support Across Four Franchise Areas.

Talk to an Immunology and Inflammation Expert

Autoimmune

  • IBD, Crohn’s disease, ulcerative colitis
  • Rheumatoid arthritis (RA), systemic lupus erythematosus (SLE)
  • Psoriasis, ankylosing spondylitis, systemic sclerosis
  • Immuno-neurology programs
  • Type 1 diabetes
  • Small molecules, biologics, biosimilars, and cell & gene therapies
  • Expert protocol and endpoint evaluation aligned with clinical practice
  • Adaptive operations suited for autoimmune disease variability

Hematology

  • Sickle cell disease, beta thalassemia
  • Rare bleeding disorders: hemophilia A, hemophilia B, von Willebrand disease
  • Neutropenia, erythropoietic protoporphyria (EPP)
  • Proven site activation across Africa, Middle East, LATAM, South Asia
  • Pediatric through elderly populations in complex hematology programs
  • First-in-human through registrational and confirmatory studies
  • Gene and cell therapy modalities for hemoglobinopathies

Nephrology

  • Lupus nephritis, C3G, IgA nephropathy (IgAN)
  • Primary hyperoxaluria, polycystic kidney disease (PKD)
  • Diabetic kidney disease, Alport syndrome, atypical hemolytic uremic syndrome (aHUS)
  • Chronic kidney disease and rare renal diseases
  • Early flare detection tools for eligibility optimization
  • Central pathology review for diagnostic accuracy
  • International patient travel coordination and pre-qualification
  • Gene/RNA therapy trials in rare renal indications

Respiratory

  • Idiopathic pulmonary fibrosis (IPF), interstitial lung disease
  • COPD, asthma, chronic cough, cystic fibrosis, bronchiectasis
  • ATS/ERS 2019-aligned spirometry training and endpoint execution
  • 94% acceptable PFT quality vs. 91% industry benchmark
  • Purpose-built site training for accurate, reproducible respiratory endpoints
  • Global site networks across North America, LATAM, Europe, & APAC

What Immunology and Inflammation Sponsors Say

Your experience is important to us.

“Worldwide is an important partner for us. We have a long history with positive experiences… we also believe in the value of long-term strategic partnerships”

VP Clinical Operations Small Biotech

“It was an open, honest but enthusiastic work environment that [Worldwide Clinical Trials] really provided. They paid attention to us as a small company, which is really good, and they made us feel like one of their more important clients even if we weren’t and that was all the difference.”

Senior Vice President of Program Operations Small Biopharmaceutical Customer

“I am very happy with the performance of Worldwide and I plan to recommend them to be one of our preferred service providers. Things are going well on our studies and the Worldwide team is performing above our expectations.”

Director of Clinical Pharmacology and Development Mid-size Pharmaceutical Customer

Your Immunology & Inflammation Leadership Team

Talk to an Immunology & Inflammation Expert

Drew Matheson

Franchise Area Lead, Respiratory Medicine

Martin Cummins

Executive Director, Project Management

Stefan Comhaire

Executive Director, Project Management

Chris Bell, PhD

Executive Director, Project Management

Awards

Industry Standard Research (ISR)  recognized Phase 2/3 CROs for comprehensive excellence across their capabilities, compatibility, expertise, quality, and reliability.

Worldwide Clinical Trials was named Most Innovative Clinical Research Organization (CRO) by the Triangle Business Journal (TBJ). This awards program celebrates the achievements of individuals and companies making critical advancements in pharmaceuticals, biotech, ag tech, and beyond, in the Triangle region of North Carolina.

Worldwide Clinical Trials, Inc., (Worldwide) the industry’s leading global, midsize, full-service contract research organization (CRO), has been recognized for excellence and honored in five categories in the 2022 CRO Leadership Awards, based on primary market research from Industry Standard Research (ISR) Reports and presented by Clinical Leader and Life Science Leader magazines. This marks the ninth consecutive year that Worldwide has been recognized as a high-performing CRO based on direct survey feedback from pharmaceutical and biotech professionals.