Immunology & Inflammation
Industry-leading immunology and inflammation experience
Due to the increase in immunologic and inflammatory disorders, paralleled by an increase in the development of targeted drugs, it is essential to deliver innovative products to market with maximum speed while preserving quality in a highly competitive research arena.
We have a broad range of global and local experience in autoimmune and inflammatory disease clinical research and consulting and a history of providing a variety of rheumatology solutions. As an immunology CRO, we have an extensive global network of sites, along with strong clinical research teams. Our therapeutic experts and validated processes, in conjunction with our comprehensive training programs, are key factors in guaranteeing high data quality.
We find the right sites for your studies
Attracting investigative sites to work on your immunology clinical trials, and motivating them to perform, is where we excel. Because we’ve always understood the importance of long-standing relationships with investigative sites, we’ve built up a network of highly specialized investigators across the world.
Many of our CRAs and project managers have worked closely with sites for years. Our therapeutic alignment, combined with our innovative data processing capabilities, make life easy for investigators, motivating them to work with us and give your studies the attention they deserve.
Our teams help select the most suitable countries and sites for your studies by means of benchmark analyses, dedicated feasibility surveys and continuous verification of timelines for study start up.
We find the right patients for your studies
Based across the world, our teams have in-depth therapeutic and operational knowledge of a broad range of immunological and inflammatory disorders, combined with a specific knowledge of the main characteristics of patients and the standard of care in their region/country.
This is crucial if your studies target sub-populations of patients with a specific geographical distribution, like biologic-naïve rheumatoid arthritis or lupus nephritis patients.
Our dedicated patient recruitment specialists have invested heavily in developing databases, strategies and processes that enable us to target, screen and recruit the right patients within planned timelines.
We understand the importance of an efficient screening process, combined with close control of enrollment, particularly for challenging diseases like lupus. We have implemented specific electronic tools to facilitate an eligibility review, conducted by our therapeutically aligned medical monitors to ensure the right patients are enrolled in a timely manner.
Our therapeutic experts have participated in the writing or review of a wide variety of study protocols in immunology and inflammation. With their extensive experience, they play a crucial role in identifying criticalities in your protocols and suggesting adaptations that can facilitate recruitment and prevent the need for amendments in the course of the study.
We ensure high quality data
Disorders of the immune system generate a hugely diverse range of symptoms affecting every part of the body. This means that conducting research in this field can be complex and require extensive knowledge and experience.
- Composite endpoints prone to significant subjectivity in indications like rheumatoid arthritis and especially systemic lupus erythematosus (SLE) continue to be a challenge. To address this, we have developed a comprehensive training program for both sites and project teams with the support of our Global Clinical Education and Strategic Programs team
- Highly experienced in conducting endpoint studies, our teams have all the experience and tools you need:
- Proprietary web-based electronic endpoint adjudication system – Trial EAS™ provides support to ongoing review conducted by our medical monitors
- Continuous assessment of our customers’ need to develop new tools, from study design to endpoint management, to ensure streamlined, high quality study progress
- Our proprietary, metrics-driven methodology, the Trusted Process® helps ensure fast delivery of study results while guaranteeing data integrity and reducing operational risk and variability
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