Expertise in Immune-Mediated Inflammatory Disorder Clinical Trials
Immune-Mediated Inflammatory Disorders
Specialists at the Forefront of IMID Research
A valuable CRO offers experiential wisdom along with forward thinking and flexibility. When medicine advances and long-held concepts evolve, you want to be working with specialists who are versed in the new approaches and already meeting fresh, related challenges. Those specialists are at Worldwide Clinical Trials.
Traditionally viewed as organ-specific with an inflammatory component, seemingly unrelated inflammatory disorders are now known to share common pathways of immune mediation. While the exact identity of the inflammatory stimulus is often unknown, genetic linkages across indications continue to emerge. Treatment is no longer based on the physical site of disease, but rather targets underlying mechanisms. For you, this major paradigm shift means opportunities for therapeutic advances across multiple indications, including new classes of drugs that target inflammation through novel mechanisms as well as expanded market share and new markets. Of course, each of the immunemediated inflammatory disorders (IMIDs) presents unique challenges.
You Need Solutions
IMIDs are a core specialty for Worldwide. Our team combines knowledge about inflammatory processes, clinical manifestations, and therapeutic targets with deep operational expertise in the challenges associated with advanced clinical research in this complex and crowded field. Worldwide professionals are attuned to the heterogeneous nature of IMIDs and able to deep-dive individual disease areas, while also sharing experiential wisdom and best practices across trials. Further, because IMID drugs have potential clinical applications extending across different therapeutic areas, we collaborate with our other core therapeutic specialty divisions to provide you optimal strategic, scientific, and operational solutions.
We Can Help
Due to exploding trial activity in this arena, competition for subjects has increased, particularly for those with unique clinical characteristics. Patient retention can be difficult in long-term studies. Sizeable placebo response rates have been observed in psoriasis, rheumatoid arthritis (RA), and ulcerative colitis (UC) trials. Patient-reported outcomes (PROs) are receiving broader attention across IMIDs. For example, the FDA is focusing more on PROs for inflammatory bowel disease, and there is growing interest in PROs in rheumatology. Worldwide’s proven solutions to these challenges include thorough site evaluation and selection based on precise metrics; careful recruitment and screening to confirm eligibility; frequent patient communication and education; intensive training of site personnel; and, if appropriate, electronic PROs using measures that are appropriate to specific disease entities.
Our IMID team has helped develop several biological therapies and also offers biosimilar experience. Over years of successful collaboration, Worldwide specialists have maintained close relationships with key opinion leaders, major academic institutions, and seasoned practitioners. These relationships plus extensive investigator networks in the optimal countries for IMID therapy development ensure highly effective, “made to measure” strategies.
Science + Service + Solutions = Success
Resources for you include:
- Consultation in clinical program development
- Access to prominent advisory boards for medical, scientific,and operational perspectives
- Well-established, global relationships with experienced investigative sites:
- Located in countries that produce high-quality data and largesubject pools
- Proficient with all international criteria and disease staging methods
- Meet most widely used standards of site performance(i.e., high recruitment and low screen-failure rates)
- Recruitment strategies tailored to each study and site
- Knowledge of geographic influences on standards of care
- Insight about local factors that can affect recruitment rates
- In-depth risk assessment and early implementation ofmitigation strategies
- Extensive knowledge of local practices and regulations, includingstandard of care and reimbursement conventions
- Proactive management of regulatory body expectations
Benefits for you include:
- Fast decision making and captured opportunities
- Optimized site selection, reliable performance, and preemptive study management
- Successful delivery of patient populations consistent with study design
- Meeting or exceeding recruitment targets within timelines
Download this information in PDF format here.