Rheumatology CRO

Advance complex disease programs with an experienced rheumatology CRO

Rheumatology pipelines are advancing across established and emerging therapeutic approaches, but execution remains challenging. You need to identify the right patients and experienced sites, manage complex and sometimes subjective endpoints, and address patient burden while maintaining consistent data quality across global studies. Success increasingly depends on indication-specific expertise, patient-and site-informed strategies, and timely visibility into study performance.

As a proven rheumatology CRO, our experience spans major and complex rheumatic diseases across Phases I-IV. We deliver rheumatology-led development and delivery strategies that combine patient- and site-informed planning, early development insights, integrated medical and regulatory oversight, endpoint protection, and real-time data surveillance. By aligning the right patients, sites, endpoints, and teams, we help you reduce development risk, protect study quality, and enable faster, more confident decisions.
 

Experience in the past 5 years with rheumatology

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clinical projects
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enrolled patients
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sites

Rheumatoid arthritis

The rheumatoid arthritis (RA) trial landscape continues to expand, putting strain on site resources. High trial saturation in places like China, the US and EU amplify competition, which is why we target regions that have high unmet needs, a large pool of RA patients, and minimal competition (such as Central and Eastern Europe). We also use early site engagement, site/patient education, resource optimization, and patient-centric tactics to support your success.

Psoriatic arthritis

Psoriatic arthritis (PsA) studies are driven by investigators and patient-reported outcomes. Because of that, we implement robust operational plans that deliver quality training, a strong operation team, and comprehensive data monitoring and surveillance. Our specialized team also has a deep understanding of the PsA patient population, which allows us to maximize study goals and patient well-being through past learnings, study design support, and more.

Axial spondyloarthritis

Axial spondyloarthritis (AxSpA) is one of the more challenging rheumatology indications due to its heterogeneity, subjective symptoms, and crowded treatment landscape. We overcome these challenges by leveraging proven sites with AxSpA experience. We also use targeted patient recruitment strategies to meet your enrollment goals, such as customized patient education materials and brochures to raise awareness and personalized study procedures for a quicker, simpler consent process.

Lupus

Lupus trials are currently the most competitive they’ve been in years. The complexities of the disease also make it difficult to treat, requiring extensive site expertise and capabilities. That’s why we identify accredited sites who’ve conducted complex studies and have robust rheumatology/hematology departments. As an inflammation and immunology CRO, we also use our deep understanding of the lupus patient experience to help your trial not only attract participants, but retain them.

Gout

As your rheumatology CRO, we can partner with you, end to end, across all phases of your gout program, even as it expands globally. We combine our expertise with a global network of 800+ specialized sites with experience enrolling patients with gout, hyperuricemia, and gouty arthritis. We leverage our relationships with these investigators to better plan and enroll your program.

Rare diseases

Our rare disease expertise produces better outcomes for your patients. Rare disease specialists at Parexel provide leadership, best practices, resources, support, and training for rare disease programs across all indications. We then combine that expertise with specialized experience in rheumatology to guide your program to success.
 

Case Study 1 of 2

Breaking ground in rheumatoid arthritis with a Phase I trial

We conducted a Phase I, double-blind, randomized, multiple ascending dose study in the US with about 30 rheumatoid arthritis (RA) patients. Challenges included:

  • Multi-day inpatient study design, presenting logistical considerations for participants under 65 years of age due to family, childcare, and work obligations
  • Restrictive inclusion criteria, including strict BMI, chest x-ray, Covid-19 vaccination, and dietary restrictions
  • A complex four-cohort structure, necessitating close monitoring of cohort enrollment caps, with each subsequent cohort unable to begin enrollment until safety reviews and 100% data cleaning were finalized for the preceding cohort
  • Intricate and frequent pharmacokinetic (PK) sampling requirements with tight 10-minute collection windows, which were difficult for older patients
  • Study-specific telemetry equipment required at all sites prior to site initiation
Situation

We conducted a Phase I, double-blind, randomized, multiple ascending dose study in the US with about 30 rheumatoid arthritis (RA) patients. Challenges included:

  • Multi-day inpatient study design, presenting logistical considerations for participants under 65 years of age due to family, childcare, and work obligations
  • Restrictive inclusion criteria, including strict BMI, chest x-ray, Covid-19 vaccination, and dietary restrictions
  • A complex four-cohort structure, necessitating close monitoring of cohort enrollment caps, with each subsequent cohort unable to begin enrollment until safety reviews and 100% data cleaning were finalized for the preceding cohort
  • Intricate and frequent pharmacokinetic (PK) sampling requirements with tight 10-minute collection windows, which were difficult for older patients
  • Study-specific telemetry equipment required at all sites prior to site initiation