For years, Sara worked in a hospital, making care possible for others. Now, after being diagnosed with breast cancer, she was the one in need of care.
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.
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
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.
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, and have run pivotal programs for dupilumab (Regeneron), the first biologic to result in global approvals for treatment of moderate to severe atopic dermatitis, and bimekizumab (UCB), among other top dermatological drugs.
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.
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.
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.
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.
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.
Access end-to-end expertise for any product enhancing, immunomodulating, or suppressing the immune system.
Tap into our in-depth experience with innovative trial designs, including decentralized, basket, and umbrella studies.
Collaborate closely with our regulatory and solution consultants for competitive, market, and trial insights.
Utilize an agile and flexible delivery model through Parexel Biotech, our division that supports emerging/mid-sized biotechs.
Maximize patient engagement with tactics that provide 3x higher enrollment rates and 6x lower dropout rates.
Benefit from our expertise with a wide spectrum of diseases not typically associated with inflammation and immunology.
Want to hear from our experts on the latest topics in inflammation and immunology? Visit our Insights Center to read, watch, and listen.