Full-Service Clinical Development for Immune-Mediated Inflammatory Disease Diseases

Start Fast. Scale Seamlessly.

Immune-Mediated Inflammatory Disease trials are defined by unpredictability. We plan for it. Our teams bring the scientific, operational, and site-level depth that complex immunology and inflammation programs require.

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development team.

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Three Phase II programs. Three new indications. All delivered ahead of schedule.

Across three consecutive Phase II immunology and inflammation programs, each one a first for Worldwide, we delivered last patient in ahead of schedule. One of those programs spanned 20 countries and 102 sites. Site identification and enrollment ran concurrently from the start, which meant the right sites were activated with the right patient pools already mapped.

  • Protocols stress-tested for real-world feasibility and regulatory alignment 
  • Consistent teams from bid defense through database lock  
  • Adaptive operations built for the variability Immune-Mediated Inflammatory Disease trials demand 
  • Fast decisions with leadership involvement  

The numbers sponsors ask about 

0 pts

lower screen failure than projected in the same study 

0 %

CRA turnover vs ~25% industry average 

0 %+

of our immunology and inflammation work is Phase II or III 

Immune-Mediated Inflammatory Disease Challenges We Solve Every Day 

Scientific care, operational creativity, and the team continuity your program requires. 

Protocols Built for the Real World 

Eligibility criteria that look right on paper can fail at the site. We build protocols around how patients present — with biomarker thresholds, feasibility data, and screen failure modeling that hold up when enrollment opens. 

The difference between an achievable protocol and one that stalls enrollment is usually made before the first site is activated. 

Adaptive Operations Built for Immune-Mediated Inflammatory Disease Variability

Immune-Mediated Inflammatory Disease timelines move. Flare windows close. Disease activity shifts between screening and dosing. Our operational model is built to flex without stopping the clock.

Adaptive resource models and rapid decision-making mean program adjustments happen without unnecessary change orders or delays.

The Team You Meet Is the Team You Get

CRA turnover in our immunology and inflammation programs runs at 9.5%. CTM turnover at 2.45%. Industry average for CRAs is closer to 25%.

That continuity runs from the business development conversation through study close. Sponsors who have worked with us across multiple programs don’t rebuild a relationship each time — and the data quality reflects it.

Depth Across the Immune-Mediated Inflammatory Disease Spectrum

More than 70% of our immunology and inflammation work over the past five years has been Phase II or Phase III. IBD, rheumatology, lupus, ankylosing spondylitis, rare systemic Immune-Mediated Inflammatory Disease, and respiratory indications.

Late-stage immune-mediated trials require a specific operational depth. Running most of our work at that level is where ours comes from.

Start Fast. Scale Seamlessly. Full Immune-Mediated Inflammatory Disease Development Support from Early Innovation Through Registrational Programs.

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GI & Digestive Diseases

  • Crohn’s Disease
  • Ulcerative Colitis (UC)
  • Inflammatory Bowel Disease (IBD)
  • Digestive Diseases

Rheumatology & Musculoskeletal

  • Rheumatoid Arthritis (RA)
  • Ankylosing Spondylitis
  • Psoriatic Arthritis
  • Psoriasis
  • Systemic Sclerosis

Systemic & Rare Immune-Mediated Inflammatory Disease

  • Systemic Lupus Erythematosus (SLE)
  • Immune-Mediated Neurology
  • Rare Systemic Immune-Mediated Inflammatory Disease
  • Auto-inflammatory Conditions

Respiratory

  • Idiopathic Pulmonary Fibrosis (IPF)
  • Interstitial Lung Disease (ILD)
  • Asthma
  • COPD
  • Chronic Cough

Early Phase Immune-Mediated Inflammatory Disease Development

Early-phase Immune-Mediated Inflammatory Disease programs require the same scientific rigor as Phase III. We build that in from day one. 

  • First-in-human Immune-Mediated Inflammatory Disease and rare immunology programs
  • Phase I/II studies combining PK/PD characterization with immunomonitoring
  • Integrated bioanalytical laboratory (J2000-validated methods)
  • Biomarker-driven patient selection and stratification
  • Basket trial and adaptive design expertise

What Immunology and Inflammation Sponsors Say

Your experience is important to us.

“The top reasons why we selected Worldwide is that they showed they had the experience and how the team interacted together, all of that collaboration spirit.”

Janssen VP Clinical Operations

Your Immune-Mediated Inflammatory Disease Leadership Team

Start fast with senior experts. Scale seamlessly with the team you were promised. 

Let’s Talk About Your Program

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

Searching for the right CRO partner to help with your clinical development needs?

At Worldwide Clinical Trials, we deliver high-quality, reliable, and timely clinical trial services to help optimize the success of your projects. For the second year in a row, data from the Industry Standard Research (ISR) report showed that Worldwide Clinical Trials was the highest-rated Phase II/III CRO across several categories.