Mila Grieg, MD, PhD
Vice President, Medical Affairs,
ACE Therapeutic Strategy Head,
Immunology & Inflammation
Immunology & Inflammation
SCROLL
Expert Immunology CRO Services for Complex Inflammatory and Immune Disorders
We address the specific challenges of multiple mechanisms and varied symptoms in inflammation and immunology clinical trials.
Immunology clinical trials address a wide and evolving range of diseases including autoimmune and immune-mediated diseases, allergic, dermatologic, rheumatologic, gastrointestinal and respiratory diseases. Each indication has its own scientific, clinical and operational challenges and requires specialized expertise in patient populations, disease evaluation, endpoint selection and clinical trial implementation. Our Immunology & Inflammation team has extensive expertise across the full spectrum of clinical research in immunology, partnering with biopharma sponsors developing novel medicines for autoimmune illnesses, allergy & asthma, as well as respiratory, gastrointestinal and dermatologic conditions. With deep therapeutic knowledge and global development capabilities, we support the advancement of programs through early clinical development, registration and beyond.
FULL-SERVICE INFLAMMATION & IMMUNOLOGY CRO SERVICES
- End-to-end clinical development (Phase I–IV)
- Study design, dose optimization and endpoint strategy
- Regulatory and global clinical development strategy
- Clinical pharmacology, PK/PD and immunogenicity (ADA/NAb)
- IGNITE™ Global site network for increased study predictability
- Biomarker, translational science and flow cytometry support
- Patient recruitment and engagement
- Technology-enabled decentralized and hybrid trial capabilities
- Central imaging, endoscopy and histopathology read
- Rater training, certification and endpoint standardization
- Pharmacovigilance, safety and long-term follow-up
- Real-world evidence (RWE) and post-marketing studies
Deep Inflammation & Immunology Trials Expertise
Our team has supported clinical trials across a wide range of immune-mediated conditions, providing the expertise needed to navigate complex development programs.
240+
Immunology & Inflammation Studies
4530+
Global Sites
28360+
Immunology & Inflammation Patients Recruited
60+
Countries
All-time years of experience
Our extensive experience as an I&I CRO enables us to tailor our approach to each unique study, ensuring optimal outcomes.
Trial Design & Development
In an evolving therapeutic landscape for immunology clinical trials, there is a need for development strategies that factor in complex patient populations and diverse disease mechanisms. Our teams balance innovative study design and trial execution using operationally feasible and scientifically competent clinical development strategies. With real-world operational expertise as an immunology CRO, Allucent minimizes protocol amendments, accelerates timelines and prioritizes patient centricity.
Proven success with biopharma sponsors: Adaptive and platform approaches in IBD and Lupus clinical trials to minimise placebo responses through tighter inclusion criteria and enrichment strategies.
Regulatory Strategy & Global Development Planning
Immunology clinical trials pose specific regulatory challenges, in particular when using novel mechanisms, biomarkers or endpoints. Our regulatory experts, including former agency reviewers, help sponsors develop pathways that are consistent with FDA, EMA and global agency expectations. We help you reduce uncertainty through efficient development with regulatory intelligence, scientific advice meetings, briefing document preparation, and proactive agency engagement on novel endpoints such as composite responder indices and biomarker-based enrichment. Early alignment of regulatory, clinical and operational strategies can help sponsors avoid costly delays and advance programs with greater confidence.
Global Site Networks & Site Feasibility
Across the board, clinical trials depend on access to the right patients, investigators, and sites. Competition is particularly intense for immunology, where multiple studies often target similar patient populations: biologic-naïve atopic dermatitis or moderate-to-severe Ulcerative Colitis patients, for instance, are heavily contested. Our global IGNITE™ site network includes consistently high-performing research sites and specialty centers with deep therapeutic expertise. With advanced feasibility modeling, AI-enabled site selection, patient identification tools, and data-driven enrollment forecasting, we help sponsors achieve more predictable enrollment timelines.
Endpoint Strategy & Biomarkers
Endpoints and biomarkers that accurately measure disease activity, treatment response, and patient outcomes are needed to show treatment benefit in immunology clinical trials. Our experts integrate patient-reported outcomes, composite efficacy measures, biomarker validation, and immunogenicity assessment to generate evidence. Further, programs can hinge on a single, subjective endpoint. We protect those endpoints from protocol design through database lock ensuring decisions rest on clean, reliable data.
Proven success with biopharma sponsors: Endpoint protection through blinded central endoscopy reads of Mayo score and UCEIS in IBD clinical trials, centralized spirometry in respiratory clinical trials, and rater training and certification for skin and joint assessments.
Tech-Enabled Trial Oversight & Data Surveillance
Immunology clinical trials generate complex datasets that require continuous oversight and timely action. Through our tech-enabled approach, Allucent proves itself as a leading immunology CRO by combining centralized monitoring, advanced analytics, risk-based quality management, and proactive data surveillance to identify trends and operational risks earlier using automated alerts (e.g. rater-score drift and missing patient’s reported outcome (PRO) data), before they impact data quality.
Proven success with biopharma sponsors: Flagging central-read endoscopy backlogs in Crohn’s disease and Ulcerative Colitis (IBD clinical trials) ensuring efficient data collection.
Patient Engagement & Retention
Many immunology, autoimmune, and inflammatory diseases require lengthy clinical trials, making patient retention and sustained engagement critical to study success, particularly where invasive assessments such as repeat endoscopy or biopsy raise dropout risk. We deploy patient-centric strategies including digital engagement platforms, concierge support services, home health solutions, and travel assistance to reduce burden and improve adherence throughout the trial journey. Whether advancing dermatology clinical trials, rheumatology clinical trials, respiratory clinical trials or even broader immunology assets, we function as an extension of your team to help drive programs forward efficiently and successfully toward regulatory approval.
Bringing new therapies to light for immune-mediated indications
Allucent’s experience as an immunology CRO extends across autoimmune, dermatology, rheumatology, respiratory, gastroenterology, allergy and systemic immunological indications, supporting sponsors throughout every stage of development. These diseases often present unique challenges, including heterogeneous patient populations, variable disease expression, complex endpoints, and competitive recruitment environments.
Our portfolio encompasses gastroenterology clinical research including 32+ IBD clinical trials: 20+ Crohn’s disease and 12+ ulcerative colitis studies, systemic autoimmune and rheumatology clinical trial expertise demonstrated through 18+ rheumatoid arthritis and 10+ lupus clinical trials, respiratory and allergy clinical trial depth spanning 17+ rhinoconjunctivitis, 12+ COPD, and 11+ asthma clinical trials, and dermatology clinical trial experience across 8+ psoriasis, plus urticaria and atopic dermatitis studies: part of a broader 240+ inflammation and immunology clinical trial portfolio.
Immunology & Inflammation Indications We Support
Systemic Immunology
- Graft-versus-host disease (GVHD)
- Scleroderma
- Stevens-Johnson Syndrome
- Vasculitis
Rheumatology
- Psoriatic Arthritis
- Rheumatoid Arthritis
- Sjogren’s Syndrome
- Systemic Lupus Erythematosus (Including Lupus Nephritis)
Dermatology
- Atopic Dermatitis
- Hidradenitis Suppurativa
- Pemphigus Vulgaris
- Psoriasis
- Urticaria
Respiratory
- Asthma
- Bronchitis
- Chronic Obstructive Pulmonary Disease (COPD)
- Cystic Fibrosis
Allergy
- Allergic Rhinitis
- Eosinophilic Esophagitis (EoE)
- Food Allergy
Gastroenterology
- Crohn’s Disease
- Ulcerative Colitis
Cell & Gene Therapy for Immunology Clinical Development
Cell and gene therapies (CGT) are opening a new frontier in immunology, with CD19 CAR-T and other engineered-cell approaches now being explored in lupus clinical trials, systemic sclerosis, myositis and other refractory autoimmune diseases. These programs carry operational demands that conventional trials never face: apheresis and manufacturing coordination, patient-specific supply logistics, specialized site readiness, cytokine release syndrome and neurotoxicity monitoring, and long-term safety follow-up that can extend for years. Allucent brings together immunology CRO expertise with established CGT experience, spanning CAR-T and TCR therapies and specialist patient-centric randomization and trial supply management (RTSM) tailored to the unique challenge of applying these modalities to autoimmune populations, helping sponsors move from first-in-human through pivotal development with the right safety and regulatory framework in place.
Rare & Ultra-Rare Immune Disorders
Many of the most challenging immunology programs target rare and ultra-rare conditions like GVHD, pemphigus vulgaris, ANCA-associated vasculitis, primary immunodeficiencies, and rare autoinflammatory syndromes, where small, geographically dispersed populations, underdiagnosis, and stringent eligibility criteria make every patient count. Allucent’s rare disease experience helps sponsors address these realities through global feasibility and strategic site selection, patient identification and advocacy-group engagement, registry partnerships, and flexible decentralized elements that reduce travel burden. We help sponsors design pragmatic, regulator-aligned programs with statistical strategies tailored to small sample sizes and single-arm designs, generating reliable evidence even when patients are geographically dispersed and limited in number.
In immunology and inflammation, a program can hinge on the integrity of a single subjective endpoint. Our job is to protect it through disciplined endpoint strategy, biomarkers, and central reads, so sponsors can make confident decisions and move faster.
Mila Grieg, MD, PhD
Vice President, Medical Affairs, ACE Therapeutic Strategy Head, Immunology & Inflammation
Meet Our Immunology & Inflammation Experts
Work alongside our I&I experts to advance innovative therapies with therapeutic expertise, strategic guidance, and seamless global execution.
- 20+ years of professional experience in clinical research and 10 years of experience as a physician
- Deep expertise in Immunology & Inflammation, Cardiometabolic & Endocrinology, and Infectious Disease
- Scientific advisor for global development programs, including asset positioning, indication prioritization, evidence-generation strategies, and regulatory interactions
Bruce McClenathan, MD
Executive Medical Director, Government and Public Health Services
- More than 25 years experience
- Lead medical affairs physician and scientific advisor for Allucent’s Government and Public Health Services portfolio
- Previously served 20+ years as clinician and researcher with the DoD
- Task Order or Site Principal Investigator on multiple clinical trials (Phase 1-4) and research studies
Merribeth Adams
Sr. Vice President,
Regulatory and Drug Development
- 40+ years of experience in clinical research and regulatory/governmental affairs
- Highly skilled in regulatory strategy and drug/product development on a global scale
- Deep knowledge of medical device, pharmaceutical, and biologics development
Explore Additional Therapeutic Areas
Additional Resources
Blogs
Protecting the Primary Endpoint: Ensuring Data Integrity in Immunology & Inflammation Clinical Trials
Learn More
Webinars
Shifting Frontiers: Navigating the Evolution of Cell and Gene Therapies from Oncology to Autoimmune Studies
Learn More
Blogs
Important Milestones in Autoimmune Research: A Timeline of Autoimmunity
Learn More
FAQs
Inflammation and immunology clinical trials evaluate new therapies for immune-mediated and inflammatory diseases, including autoimmune disorders, respiratory diseases, dermatological conditions, allergies, and gastrointestinal diseases. These studies assess the safety, efficacy, and long-term outcomes of innovative treatments.
An immunology CRO provides end-to-end support for immunology clinical trials, including study design, regulatory strategy, site selection, patient recruitment, data management, biomarker integration, and global trial execution to help sponsors accelerate drug development.
Immunology and inflammation clinical research covers a wide range of therapeutic areas, including rheumatology, dermatology, respiratory diseases, allergy, gastroenterology, autoimmune diseases, rare immune disorders, and cell & gene therapy.
Immunology clinical trials often involve complex patient populations, variable disease activity, challenging endpoints, competitive patient recruitment, and evolving regulatory requirements. An experienced immunology CRO helps address these challenges through specialized trial design and operational expertise.
Biomarkers help evaluate disease activity, treatment response, and patient outcomes. They support patient selection, endpoint assessment, and regulatory decision-making, improving the efficiency and quality of immunology clinical trials.
Allucent combines therapeutic expertise, global operational capabilities, regulatory knowledge, advanced technologies, and patient-centric strategies to support complex immunology and inflammation clinical trials from early development through commercialization.
Allucent supports sponsors across a broad range of immune-mediated diseases, combining deep therapeutic expertise with global operational capabilities. As a trusted CRO for dermatology clinical trials, we support studies in psoriasis, atopic dermatitis, hidradenitis suppurativa, and urticaria. We also provide specialized support as a CRO for respiratory clinical trials, with experience in asthma, COPD, and cystic fibrosis, as well as a CRO for allergy clinical trials, helping sponsors advance therapies for allergic rhinitis, food allergy, eosinophilic esophagitis (EoE), and other allergic disorders. Our expertise also extends to rheumatology clinical trials, including rheumatoid arthritis and lupus, and gastroenterology clinical trials, supporting the development of therapies for Crohn's disease, ulcerative colitis, and other inflammatory bowel diseases.