There is a high unmet need for treatment options for rheumatic diseases; however, these clinical trials present unique challenges, including complex patient recruitment, lack of validated outcome measures, complex study designs, and a competitive landscape. You can be confident in the successful design and execution of your rheumatology study by partnering with Medpace experts who have a thorough understanding of the complex conditions experienced by patients and potential barriers that may arise when conducting rheumatology trials.
Medpace’s expertise and consistent track record of success as a full-service CRO across various therapeutic areas provides the flexibility necessary to meet the unique needs of rheumatology research. Our cross-specialty experience is key for managing complex trials across systemic lupus erythematosus, rheumatoid arthritis, spondyloarthropathies, and more.
Making the Complex Seamless® in Global Rheumatology Clinical Trials
The Medpace rheumatology team has successfully conducted Phase III registration trials leading to marketing authorization of products for systemic autoimmune rheumatic diseases and inflammatory arthropathies. Drive the successful execution of your rheumatology trials through a partner with strong communication, well-established site relationships, and experience collaborating with global regulatory authorities. Medpace can support your clinical trials through:
Extensive experience in biosimilars, combination therapies, and new approaches such as:
Immunomodulatory biologics
Genetically altered cell therapies
Gene transfer-mediated immunotherapies
Monoclonal microbial immunomodulation
Selective Kinase Inhibitors
Global regulatory affairs team able to lead, consult, and manage complex regulatory approval processes, along with an experienced regulatory submissions team to support site contract negotiations and expedite start-up
Strong, long-term relationships with investigators, experienced sites, networks, and key opinion leaders (KOLs) help facilitate strategic site selection, start-up, and recruitment efforts
A flexible and highly-customizable ePRO solution that is fully-integrated into ClinTrak®, Medpace’s proprietary clinical trial management system
Strategic guidance from our dedicated, in-house patient recruitment and retention teams who are experienced in recruiting patient populations, including clinical trials in rare rheumatology diseases, such as systemic sclerosis and vasculitis
Integrated Services
Our comprehensive CRO services are supported by our wholly-owned Central Laboratories, Bioanalytical Lab, Imaging and ECG Core Lab, and Phase I Unit, as well as ClinTrak®, a Clinical Trial Management System that ties all study data together in a single platform with client access.
Medpace Core Lab
CRO and imaging integration—imaging expertise and clinical trial experience ensures that imaging components are seamlessly integrated into the complex structure of the overall trial. Medpace Core Labs (MCL) provide a breadth of expertise across a broad spectrum of rheumatology imaging. Notably, we use a web-based image management system with integrated quantitative tools to analyze a wide range of medical imaging modalities such as MRI, CT, PET, x-ray, etc. for confirmation of eligibility, safety, and efficacy evaluations.
Rheumatology imaging expertise:
Rheumatology specific medical imaging protocols
Qualitative visualization
Serial quantitative measurements
Outcome measures in rheumatology (OMERACT) guidelines
Rheumatoid arthritis MRI score (RAMRIS) and other scoring methods
Global Central Labs
Our wholly-owned central laboratory—with locations in the US, Europe, China, and Singapore— offers a menu of validated biomarkers associated with rheumatology with the ability to rapidly establish and validate novel assays as needed.
Our cross-functional teams of medical, operational, and regulatory experts are actively involved throughout the lifecycle of the project to create effective and efficient study designs for Sponsors of all sizes. Our embedded board-certified rheumatologists and immunologists have a thorough understanding of the complex conditions that cause these diseases, as well as the medical complications experienced by patients. They provide strategic direction for study design and planning, train operational staff, work with Investigators, provide medical monitoring, and meet with regulatory agencies.
Medpace has experience conducting global Phase I-IV trials across a spectrum of rheumatology diseases, including but not limited to:
Systemic Lupus Erythematosus & Lupus Nephritis
Rheumatoid Arthritis
Osteoarthritis
Psoriatic Arthritis
Spondyloarthropathies – Non-radiographic and radiographic axial spondyloarthritis
“Being part of the Medpace medical team allows me to continue to use my medical knowledge in collaboration with a team dedicated to developing exciting and innovative treatments in areas of need, including rheumatology.”
Andrew Head, MD Medical Director, Mepdace
“Rheumatology research has seen significant advancements, offering more treatment options; however, there still remains an unmet need for several rheumatology conditions. By being involved in the development of safe and effective medical therapeutics, Medpace is offering new hope to patients through treatments that could provide a better quality of life and possibly a cure.”
