Full-Service Clinical Development for Autoimmune Diseases

Start Fast. Scale Seamlessly.

Autoimmune trials are defined by unpredictability. We plan for it. Our teams bring scientific, operational, and site-level depth that matches the complexity of these programs. 

Tell us about your study

We’ll connect you with the right clinical
development team.

Start a Conversation

Three consecutive Phase II autoimmune programs. All delivered ahead of schedule.

Across three consecutive Phase II autoimmune and inflammation programs, each one an indication we were running for the first time, 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 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 autoimmune variability
  • Fast decisions with leadership involvement

The numbers sponsors ask about 

0 %

above enrollment target in a Phase II autoimmune program

0 pts

lower screen failure than projected in the same study 

0 %

CRA turnover vs ~25% industry average 

0 %+

of our autoimmune and inflammation work is Phase II or III 

Autoimmune Challenges We Solve Every Day

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

Icon list

Protocols Built for the Real World

Eligibility criteria that look right on paper can fail at the site. We build autoimmune protocols around how patients present, with biomarker thresholds and feasibility data that hold up when enrollment opens. The difference between an achievable protocol and one that stalls is usually made before the first site is activated.

Icon list

Adaptive Operations Built for Autoimmune Variability

Autoimmune timelines move. Flares close enrollment windows, disease activity shifts between screening and dosing, and concomitant medications complicate eligibility. Our operational model flexes without stopping the clock, so program adjustments happen without change-order delays.

Icon list

The Team You Meet Is the Team You Keep

CRA turnover in our immunology and inflammation programs runs at 9.5%, and CTM turnover at 2.45%. Industry average for CRAs sits closer to 25%. That continuity holds from bid defense through database lock, and data quality reflects it across long autoimmune programs.

Icon list

Depth Across the Autoimmune Spectrum

More than 70% of our autoimmune and inflammation work over the past five years has been Phase II or Phase III. That depth covers IBD, rheumatoid arthritis, lupus, ankylosing spondylitis, psoriasis, systemic sclerosis, and rare systemic autoimmune conditions, across small molecules, biologics, and advanced therapies.

Start Fast. Scale Seamlessly. Full Autoimmune Development Support from Early Innovation Through Registrational Programs.

Talk to an Autoimmune Expert

GI-Autoimmune & Digestive

  • Inflammatory bowel disease (IBD)
  • Crohn’s disease
  • Ulcerative colitis (UC)
  • Celiac disease
  • Biologic and biosimilar programs
  • Adaptive trial designs for GI-autoimmune variability

Rheumatic & Connective Tissue

  • Rheumatoid arthritis (RA)
  • Systemic lupus erythematosus (SLE / lupus)
  • Psoriasis and psoriatic arthritis
  • Ankylosing spondylitis
  • Systemic sclerosis (scleroderma)
  • Non-rare autoimmune conditions

Emerging & Complex Autoimmune

  • Immuno-neurology
  • Atopic dermatitis
  • Connective tissue disorders
  • Rare inflammatory disease
  • New gene/cell therapy modalities in autoimmune

Early Phase Autoimmune Development

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

  • First-in-human autoimmune compound studies
  • 200-bed clinical pharmacology unit (San Antonio, TX)
  • SAD/MAD, PK/PD characterization for immunomodulatory agents
  • Integrated bioanalytical laboratory (2,000+ validated methods)
  • Biomarker-driven patient selection and stratification
  • Basket trial and adaptive design expertise

What Autoimmune 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.”

VP Clinical Operations Small Biotech

Your Autoimmune Leadership Team

Start Fast with senior experts. Scale Seamlessly with the team you were promised.

Talk to an Autoimmune Expert

Chris Bell, PhD 

Executive Director, Project Management (Autoimmune)

30+ years running global autoimmune programs, with deep focus on inflammatory bowel disease and multinational clinical research. 

Nathalie Spinnewyn, MS

Executive Director, Project Management (Autoimmune)

Global autoimmune program delivery across rheumatology, lupus, and rare systemic autoimmune indications. 

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.