Recent data suggests that up to 25% of the population may suffer from various rheumatic diseases
Systemic autoimmune rheumatic diseases (SARDs) are on the rise around the world. Researchers have identified more than 100 rheumatic disorders and suspect at least 40 additional diseases of having an autoimmune background. These diseases are chronic and can be life-threatening. A rheumatic disorder may affect one or more organs including joints, bones, muscles, the skin and connective tissue, and blood vessels.
With improvements in understanding of the immune system and molecules that mediate inflammation, new therapies continue to be developed for multiple autoimmune indications. Studies often share similar clinical and operational considerations, challenges and risks. It is important to work with a research partner that has experience across multiple therapy areas.
ICON leverages its expertise to advance and help companies develop innovative medicines for people living with rheumatic autoimmune diseases. We provide strategic direction and end-to-end services to support all phases of autoimmune therapies development. As a full service contract research organisation, we have the experience and the in-depth knowledge to handle all aspects of product development. Our expert teams anticipate the challenges and offer proven mitigation strategies to ensure patient safety as well as efficient study operation and execution. This ICON team of core professionals includes four board certified rheumatologists and is organized within the Rheumatology Center of Excellence (CoE), supporting programs with applied knowledge and past projects experience.
ICON Rheumatology experience in the last ten years
ICON holds global clinical trial experience in a variety of immunology areas, including:
Our integrated services include:
- Early Phase Research: Staff dedicated exclusively to conducting early phase research, from First-in-Human (FIH) through Proof of Concept (POC)
- Site Selection and Engagement: Close relationships with thousands of investigators and Key Opinion Leaders (KOLs), Electronic Medical Records on 100 million patients, and technology solutions for training and engaging sites
- Expedited Study Start Up: Smart processes and specialized teams to support your race to market
- Adaptive Study Design: Adaptive trial designs through ADDPLAN® software combining comprehensive tools with state-of-the-art methodology
- Patient Recruitment and Engagement: A focused approach that includes patient-centric services, site support services, and an online learning management system - FIRECREST
- An expert Clinical Outcomes Assessments group with experience in dermatology and rheumatology PRO and Clinical assessment instruments creation and validation
- Medical Imaging: Over 200 imaging specialists providing photo services, centralized assessment and adjudication of study endpoints
- Independent DMC Management and Endpoint Adjudication IDEA with experience in Inflammation and Autoimmunity endpoints
- Laboratory Services: A global network of wholly-owned laboratories that can receive samples within 48 hours
- Biostatistical Analysis: A dedicated team to help in developing your protocol and perform PK modeling calculations
- Commercialisation and Outcomes: Professional services to establish and communicate your product’s unique clinical and economic value
- Data Analytics: ICONIK decision-support platform provides a single view of study data to manage data quality, support a risk-based approach via analysis and visualization of trends, ensure compliance with assessment schedules, assess site performance, analyse and manage quality of rating scales and scoring tools