Full-Service Clinical Development for...

Full-Service Clinical Development for Autoimmune Diseases

Start Fast. Scale Seamlessly.

Autoimmune trials are defined by unpredictability, disease flares that don’t follow enrollment schedules, complex endpoints that require alignment with clinical practice, and protocols that need to work in the real world, not just on paper.

Learn about our Autoimmune Diseases service offerings

We do things differently. Our autoimmune teams reinforce protocols with senior scientific and medical review before the first site opens. We adapt operations to autoimmune variability rather than forcing trials into rigid frameworks. The team you meet at the bid defense runs your trial from startup to database lock.

  • Expert protocol and endpoint evaluation aligned with clinical practice and regulatory expectations
  • Consistent, senior-supported delivery team
  • Adaptive operations suited for the unpredictability of autoimmune disease
  • Rapid decision-making without bureaucratic delays
  • Deep experience across IBD, Crohn’s, UC, RA, SLE, psoriasis, ankylosing spondylitis, and systemic sclerosis

From early-stage innovation through registrational programs, we help you start fast and scale seamlessly across the autoimmune spectrum.

Talk to an Autoimmune Expert

Autoimmune Challenges We Solve Every Day

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

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Protocols Built for the Real World

Autoimmune protocols fail when they’re designed in isolation from clinical practice. Our senior scientific and medical team reviews every autoimmune protocol for feasibility alignment — ensuring endpoints are achievable, eligibility criteria are practical, and regulatory expectations are integrated from the start. This isn’t a checkbox exercise. It’s the difference between a study that recruits and one that stalls.

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Adaptive Operations Built for Autoimmune Variability.

Autoimmune diseases don’t follow linear timelines. Flares happen unpredictably. Patients cycle through periods of activity and remission. Concomitant medications complicate eligibility. We build operational flexibility into every autoimmune program. This ranges from adaptive monitoring strategies to rapid protocol amendments. Your trial adapts to the disease, not the other way around. Our empowered teams make decisions without change-order delays or governance bottlenecks.

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The Team You Meet Is the Team You Keep

Autoimmune programs are long. They require institutional knowledge, investigator relationships, and operational memory that can’t be rebuilt every time a CRO rotates staff. Our autoimmune delivery teams have deep tenure and stable leadership. Medically informed CRAs understand the conditions they’re monitoring. Senior leadership is directly accessible throughout the delivery process.

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Depth Across the Autoimmune Spectrum

Our autoimmune expertise spans the full range of immune-mediated inflammatory conditions, from high-volume indications such as rheumatoid arthritis and IBD to complex, rare autoimmune programs. We support small molecules, biologics, including biosimilars, and advanced therapies such as cell and gene therapies across all phases of development.

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
  • Digestive diseases with autoimmune etiology
  • 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
  • Small molecules, biologics, and advanced therapies

Emerging & Complex Autoimmune

  • Immuno-neurology
  • Atopic dermatitis
  • Connective tissue disorders
  • Rare inflammatory disease
  • Cell and gene therapy for autoimmune indications
  • First-in-human and basket trial designs
  • New gene/cell therapy modalities in autoimmune

Early Phase Autoimmune Development

  • 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 lead)

Experienced executive with nearly 30 years leading global digestive disease programs, specializing in inflammatory bowel disease and overseeing multinational clinical trials.

Nathalie Spinnewyn, MS

Executive Director, Project Management