Rheumatology

Rheumatology Clinical Trials require specialised expertise due to the complexity of rheumatic diseases.

Accurate trial design, comprehensive safety monitoring, and effective patient engagement are critical to the successful evaluation of treatments for these chronic and debilitating conditions. At iNGENū CRO, we provide tailored, high-quality, and cost-effective solutions that accelerate the development of novel rheumatology therapies.

Our clinical team has comprehensive experience in a range of rheumatological conditions, including:
  • Rheumatoid Arthritis (RA)

  • Psoriatic Arthritis (PsA)

  • Osteoarthritis (OA)

  • Ankylosing Spondylitis (AS)

  • Systemic Lupus Erythematosus (SLE)

  • Juvenile Idiopathic Arthritis (JIA)

  • Gout and Crystal Arthropathies

  • Fibromyalgia

Disciplined,

Cost-Efficient Execution

while maintaining the Highest Quality

Local Trials,

Global Approvals

Access FDA Regulatory Expertise

Our Clinical Team has over

120

years

of Combined Clinical Trial Experience

Addressing Common Pain Points Associated with Rheumatology Clinical Trials 

Rheumatology trials often rely on subjective assessments of disease activity and pain, leading to potential variability between evaluators and across sites.

iNGENū addresses this pain point with Standardised and Objective Assessments

We implement validated disease activity scores and patient-reported outcome measures (PROMs) such as DAS28, CDAI, or RAPID3. Comprehensive training and centralised review processes ensure consistency and accuracy in assessments across all trial sites.

Rheumatology studies frequently involve sophisticated biomarkers and imaging techniques such as ultrasound, MRI, or X-rays to assess joint damage and inflammation.

iNGENū addresses this pain point with Centralised Imaging and Biomarker Analysis

Our centralised imaging platform ensures standardised protocols and expert analysis, minimising variability. We also utilise advanced biomarker laboratories with rigorous quality control measures to ensure reliable data collection.

Finding and retaining patients in rheumatology trials can be challenging due to disease variability, strict eligibility criteria, and the chronic nature of these conditions.

iNGENū CRO addresses this pain point with Tailored Recruitment Strategies

We utilise robust patient databases, partnerships with rheumatology clinics, and collaborations with patient advocacy groups to efficiently identify and engage suitable candidates. Our patient-centric approach includes flexible scheduling, telehealth options, and continuous patient support, reducing dropout rates.

The subjective nature of symptoms in rheumatic diseases can result in significant placebo responses, complicating trial results interpretation.

iNGENū addresses this pain point with Rigorous Blinding and Statistical Techniques

We employ robust blinding methods and innovative trial designs, such as crossover or withdrawal studies, to mitigate placebo effects. Our biostatisticians use advanced statistical analyses to accurately differentiate true treatment effects from placebo responses.

Many rheumatology trials involve long-term treatments, such as biologics or immunosuppressants, which require vigilant safety monitoring due to potential adverse effects.

iNGENū addresses this pain point with Comprehensive Safety Monitoring

Our dedicated safety boards continuously monitor patient data, ensuring rapid identification and management of any adverse events. Our real-time safety reporting and proactive risk management protocols prioritise patient safety throughout the trial duration.

Rheumatology Clinical Trial Resources

Overcoming Challenges in Cutaneous Lupus Erythematosus Clinical Trials - iNGENū CRO (1)

Cutaneous Lupus Erythematosus

Gain key insights into overcoming challenges in CLE Clinical Trials.

The Road to Osteoarthritis Drug Approval

Osteoarthritis

Discover lessons from successes and failures on the road to osteoarthritis drug approval.

iNGENu CRO - Rheumatoid Arthritis Clinical Trials

Rheumatoid Arthritis

Navigating diagnosis, endpoints, and protocol enhancements in Rheumatoid Arthritis Clinical Trials.

The iNGENū CRO Difference

iNGENu - FDA
Local Trials, Global Approvals

We uniquely combine Australian expertise with direct FDA submission capabilities, offering a streamlined path for sponsors to achieve global approval. Our seamless integration allows trial data from Australia to be submitted directly to the FDA via our E-Gateway, eliminating the need for third-party intermediaries.

iNGENu - cost efficient
Disciplined, Cost-Efficient Execution

iNGENū CRO takes a highly strategic and disciplined approach to clinical research, ensuring that every dollar is directed toward generating meaningful outcomes. Our trials are designed with efficiency in mind, eliminating unnecessary costs while maintaining the highest scientific and regulatory standards.

iNGENu - APAC
Australian-Headquartered, Asia-Pacific Reach

We provide sponsors with comprehensive trial capabilities across the Asia-Pacific region, offering a seamless combination of cost-efficiency and high-quality clinical trials. We leverage the region's competitive pricing while maintaining rigorous Australian-based project management and clinical oversight.

"We have been using iNGENū for a Phase 1, first-in-human trial of our investigational drug. We have used iNGENū for: Medical writing, project management, clinical data management and full end-to-end, clinical trial execution and monitoring.

We have been very happy with all aspects of the management of the clinical trial and have been particularly impressed by the out-of-the-box creative solutions to speed up and reduce overheads for our company during this clinical trial."

Giles Moss
Chief Executive Officer

iNGENu testimonial-logos-monotone-1

Ready to discuss your Rheumatology Clinical Trial?

 

Ready to discuss your trial?