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Specialized CRO services for rheumatology studies.
We’re all in.
Rheumatology specializes in diagnosing and treating over 20 rheumatic and musculoskeletal diseases (RMDs) that can impact joints and organs in both children and adults. Given the complexity and variety of these conditions, a specialized CRO is essential. Indero serves your clinical trial needs from every side—from science to operations and protocols to patients–ensuring the highest standards of data integrity and reliability.
As your rheumatology CRO, Indero offers the expertise to advance a broad spectrum of indications. Our team understands the complexities and unique demands of immune-mediated diseases, bringing depth and precision to every study we support. Here are some of the indications we focus on:
SLE trials face unique complexities due to the disease’s heterogeneity, different treatment paradigms across the globe, uncontrolled use of background glucocorticoids, and use of convoluted composite endpoints that capture organ-specific responses and overall disease activity.
Systemic sclerosis is a rare autoimmune disease characterized by immune imbalance, fibrosis and vascular abnormalities, making endpoint selection and recruitment particularly challenging.
The spondyloarthritis spectrum encompasses a range of diseases sharing common inflammatory pathways but requiring distinct endpoints and trial designs.
Our team employs validated composite endpoints like SLE Responder Index (SRI), British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) and organ-specific indices such as EULAR/ERA-EDTA renal response and CLASI skin score.
We partner with specialized lupus centers to accelerate recruitment of well-characterized patients.
Centralized adjudication of disease activity at entry and during study duration by expert “lupus trialists” ensures consistent assessment of disease activity status across sites, enhancing data reliability, detection of efficacy signals and controlling placebo response rates.
We are familiar with the standardized imaging techniques (e.g., HRCT for lung fibrosis) and pulmonary function testing to capture subtle changes in disease progression.
Our trial network, focused on rheumatology sites, ensures access to experienced investigators and accelerates recruitment.
Rigorous training of site staff in mRSS (hands-on workshops with real patients and training certification) and lung function assessment ensures consistent, high-quality data collection.
We utilize centralized imaging reviews with radiologists trained in SpA standardized scoring systems (e.g., SPARCC, mSASSS).
Our dual expertise in dermatology and rheumatology ensures consistent staff training on assessment of both musculoskeletal and skin outcomes in PsA.
Clear protocol recommendations on how to manage emergent extra articular manifestations (e.g. uveitis, inflammatory bowel disease), clear derivation channels to relevant specialists for assessments and clear definitions of rescue therapy alternatives and IMP discontinuation rules.
Platform trial designs enable sponsors to evaluate multiple mechanism of actions, reducing costs and increasing trial efficiency.
Indero’s full-service model supports rheumatology studies from start to finish. With scientific and medical rigor, operational efficiency, and specialized clinical development, we prioritize data quality at every step. Our tailored insights and quality data ensure on-time, effective study execution.
Indero is a specialized CRO with deep expertise in rheumatology and dermatology, bringing over 25 years of experience in clinical trial delivery. Our full-service approach—from protocol design and patient recruitment to monitoring and biometrics—prioritizes data quality in all processes and training programs. This commitment equips biotech and pharmaceutical sponsors with the clinical rigor and medical expertise to drive rheumatology studies to success. Our operations span across the world, with capabilities in North America, Europe, Latin America, and Asia Pacific. Our dermatology connections include over 3,100+ investigators, making us a trusted partner for efficient, effective dermatology trials at a global scale.
“. . .From the initial synopsis development to the final stages of study conduct, the synergy between our teams was palpable and was underpinned by Indero’s strong relationships with sites, investigators and KOLs. . .”
Senior Vice President, Clinical Development
Indero successfully navigated the complexities of a study on Systemic Sclerosis (SSc), demonstrating strategies that enhanced subject retention and streamlined recruitment.
The Dermatology Center of Indiana and the Indiana Clinical Trials Center
“Outstanding level of support.
Indero has truly been a reliable CRO partner to us over the years and has continuously offered an outstanding level of support to our recruitment activities.”
A rheumatology CRO specializes and understands the caveats and challenges of rheumatology diseases and target populations. They combine medical, scientific and clinical rheumatology expertise to ensure successful trial management and execution.
A specialized CRO enhances your trial by providing medical, scientific and clinical rheumatology expertise in addition to tailored patient engagement strategies, and streamlined operations. Their deep understanding of regulatory requirements and established rheumatology-specific networks can lead to more efficient trial execution and improved patient outcomes, ultimately advancing treatment options in this critical field.
Wherever
You’re Going,
We’re all in.
Need help with your next study? We want to learn more. Fill out the form on the right and one of our experts will be in touch.
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We orchestrate all study activities and deliverables, including site selection process, budget and contract negotiations, and patient engagement, recruitment enrollment projections, all while respecting your study timelines.
Our dedicated patient recruitment and advertising team integrates with the study team to tailor recruitment strategies, customize central ad campaigns, develop advertising creative, and continuously track and adapt recruitment goals. Our patient-centric approach is enhanced by Clinago, our technology enabled recruitment service.
Leveraging an average of over 15 years of industry experience, our seasoned clinical operations team offers both adaptive monitoring services (on-site and remote) and centralized monitoring services. All of our team members undergo extensive dermatology training. We ensure compliance with rheumatology study protocols, sound clinical practices and applicable regulations. Our team is skilled in identifying data inconsistencies, performing trend analysis, and detecting patterns or outliers. Additionally, we offer tailored training programs for sites in rheumatology to ensure they are well-equipped with the latest knowledge and best practices.
We provide clinical oversight to protect subject safety and maintain data integrity. Our responsive medical monitors work directly with sites to address issues quickly, ensuring adherence and reliable data that keep your rheumatology trials on track.
Our pharmacovigilance services span various therapeutic areas and track, assess, and report safety data to manage your trial risks effectively. Through continuous monitoring and regulatory reporting, we ensure subject safety, providing you with the confidence and clarity you need.
Our extensive biometric services cater to all your biostatistics and data management requirements, meticulously aligned with your rheumatology study goals and other medical fields. We offer a range of services, including adaptive design, strategic statistical consulting, sample size and power calculations, database design, medical coding, and thorough data validation, review, and cleaning.
With deep expertise and vast operational experience, we can help you design an innovative and efficient patient-centric rheumatology study that meets your scientific objectives while optimizing your financial investment. We engage with key opinion leaders to shape trial designs leading to improved study site engagement.
We can help you navigate the global regulatory landscape and provide clinical development consulting, covering end-to-end needs, including drug and device submissions, medical and scientific writing, clinical pre-feasibility, scientific support, and even meeting with regulatory agencies.
Our long-standing relationships with key opinion leaders and highly performing sites, result in optimized start-up processes that deliver strong results in the least amount of time. As part of our site evaluation, our team utilizes past performance metrics, recruitment projections based on competitive landscape, and detailed feasibility surveys to determine a site’s capabilities and interest in a study.
We provide expert scientific and regulatory writing services, delivering high-quality clinical study protocols designed and drafted by our team of clinical scientists, rheumatologists, and operations specialists, with contributions from clinical study coordinators, all tailored to your requirements and specifications.
Our quality assurance service ensures the highest standards of compliance and data integrity. We implement rigorous quality control processes to identify and mitigate risks early.
We are excited to announce that Innovaderm is rebranding our CRO division as Indero (in-dAIR-oh). This rebranding reflects our ongoing commitment to innovation and our expansion into the field of rheumatology, a therapeutic area closely linked to dermatology. As a dual-focus CRO specializing in both dermatology and rheumatology, this strategic decision marks a significant milestone for our organization, and we are eager to embark on this new chapter with our valued partners and clients. Innovaderm will continue to operate as a CRU for dermatology studies.
Our long-standing relationships with key opinion leaders and highly performing sites, result in optimized start-up processes that deliver strong results in the least amount of time. As part of our site evaluation, our team utilizes past performance metrics, recruitment projections based on competitive landscape, and detailed feasibility surveys to determine a site’s capabilities and interest in a study.
We orchestrate all study activities and deliverables, including site selection process, budget and contract negotiations, and patient engagement, recruitment enrollment projections, all while respecting your study timelines.
