Inflammation and Immunology CRO
Get agile support for your most urgent needs
Speed and agility in clinical trials have never been more important. Our broad knowledge of the underlying mechanisms of diseases, paired with our comprehensive medical expertise and vast global operations, enable our team to respond quickly to the most urgent demands across indications in inflammation and immunology.
Optimize development with a unique, MOA-driven model
Where many CROs approach inflammation and immunology as separate medical subspecialties, our team tackles them with a unified focus on your drug’s mechanism of action (MOA). By deeply understanding the MOA, whether your drug ultimately goes into an inflamed bowel, a rheumatoid joint, or the back of an inflamed eye, we’re able to drive development forward with greater efficiency and insight. This model is a key reason for the rapid expansion of our capabilities and experience in inflammation and immunology.
Our experts in inflammation & immunology
Bharti Arya
Executive Director, Global TA Head Ophthalmology
Lachy McLean
Senior Vice President, Global Section Head, Immunology & Inflammation
Michelle Pietzak, M.D.
Global TA Section Head, Gastroenterology
Tatyana Zubkovskaya, M.D.
Senior Medical Director
Simona Stankeviciute, M.D., M.Sc.
Vice President, Technical
Experience in the past 5 years with inflammation & immunology
+
clinical projects
+
enrolled patients
+
sites
Allergy/immunology
Allergy has entered an exciting time with unprecedented innovation among both old and new therapeutics, including biologics and immunotherapies. Led by a board-certified allergist-immunologist, our experienced team plays a critical role on the path to approval. We have successfully executed studies across the spectrum of allergic diseases and immunodeficiencies, including food allergy, asthma, immunotherapy (seasonal and perennial allergens), immunodeficiency, and more. Our allergy experiences range from Early Phase trials conducted in our own Early Phase Clinical Units to complex global trials in Phases II-IV, and we have relationships with several environmental exposure chambers for controlled allergen exposure studies.
Medical Director
Senior Clinical Operations Leader
Senior Medical Director
Dermatology
Our work in dermatology studies ranges from Early Phase trials conducted both in our own Early Phase Clinical Units (EPCUs) and as part of complex global trials in Phase II-IV, together with substantial regulatory drug development. Our extensive late-phase experience includes the largest Phase III moderate-to-severe plaque psoriasis program to date. In the past five years, we’ve conducted 90+ dermatology clinical projects and enrolled 25,000+ patients.
We are also experienced in conducting trials in niche areas such vitiligo, hidradenitis suppurativa, and prurigo nodularis.
Medical Director
Senior Medical Director
Clinical Operations Leader
Gastroenterology
One of our overarching strengths is our extensive therapeutic area expertise in relation to inflammatory bowel diseases, which often overlap with other diseases that can cause inflammation of the large intestine. Led by a board-certified gastroenterologist, our experienced team plays a critical role on the path to approval. Through collaboration with experts in other therapeutic areas, such as in immunology, we provide a comprehensive solution for challenges with study design, operational considerations, and endpoint evaluation.
Through it all, we also stay focused on centering the patient. Especially with patient populations facing chronic conditions with extended complications, we ensure they don’t take on any undue risk.
Global TA Section Head, Gastroenterology
Medical Director, GMS Inflammation & Immunology
Medical Director, GMS Inflammation & Immunology
Ophthalmology
Our team has a wealth of experience conducting ophthalmology research, from first-in-human to registration and postmarketing studies, including 50+ clinical projects and 11,500+ enrolled patients in the past five years. We’re the premier CRO provider in developing new targets through gene therapies for degenerative eye diseases and bring unique experience to the field of inflammatory eye diseases.
We provide a single point of contact so you have fast access to comprehensive, worldwide expertise. We offer extensive clinical and investigator experience encompassing all ophthalmology subspecialties, providing strategic and practical solutions for proposed trials. And our team has strong expertise in managing and supporting site certification during the start-up phase, including fluorescein angiography and certifications for newer imaging and testing modalities, such as OCT-A and microperimetry.
Rheumatology
Our experience in rheumatology includes key studies in multiple indications, such as rheumatoid arthritis, systemic lupus erythematosus (SLE), psoriatic arthritis, ankylosing spondylitis, and gout. Led by a board-certified rheumatologist, our team has expertise that includes adjudication in complex diseases like SLE.
We are a full-service provider that can partner with you from Early Phase trials to global Phase II-VI trials, with expertise in both adult and pediatric rheumatology. Our site network and global footprint provide access to key patient populations to ensure your trial is fully representative.
Medical Director
Senior Medical Director
Senior Clinical Operations Leader
Project Leader
Senior Medical Director
Associate Medical Director, Inflammation & Immunology
Advantages
End-to-end expertise, no matter the product
Our comprehensive team of physicians has many years of experience treating inflammatory immunologic disorders and in designing and executing trials across every phase of drug development. That includes everything from first-in-human studies to late phase studies, regulatory, market access, and postmarketing study commitments. We’re ready to assist with speed and precision the development of any product enhancing, immunomodulating, or suppressing the immune system.
Collaborating with patients from the beginning
Patients should be involved in all aspects of the clinical trial — not just from the moment they join as a participant, but from the moment we start developing protocols. The patient’s voice can help improve trial design, identify meaningful outcomes, and more. That’s why we approach every project as a collaboration with the patients, from start to finish.
Frequently asked questions
Inflammation and immunology CRO services refer to specialized clinical research support provided by CROs like Parexel for pharmaceutical and biotechnology companies developing drugs and therapies in the fields of inflammation and immunology. These services encompass a wide range of activities to assist in the drug development process, from early-stage research through clinical trials and regulatory approval.
Agile clinical trials in inflammation and immunology drug development can be achieved through several key strategies. These include implementing adaptive trial designs, patient-centric approaches, and biomarker-driven strategies. Innovative endpoint selection, real-world evidence integration, and advanced analytics with AI can also enhance trial agility. Additionally, utilizing decentralized or hybrid trial models, incorporating wearable devices for data collection, and employing flexible protocols that allow modifications based on interim data analysis can significantly improve the efficiency and effectiveness of clinical trials.
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