Medpace’s cross-functional team of experts has extensive experience in successfully designing and executing rheumatology trials.
There is a significant unmet need for effective therapies in rheumatic diseases; however, clinical trials in this field present unique challenges, including complex patient recruitment, limited validated outcome measures, complex study designs, and an increasingly competitive landscape. Be confident in the successful design and execution of your rheumatology study by partnering with Medpace experts who have a deep understanding of the complex conditions experienced by patients and the potential barriers that may arise when conducting rheumatology trials.
Medpace’s full-service model, extensive rheumatology experience, and proven track record across various therapeutic areas provide the flexibility necessary to support the unique needs of these studies. Our cross-specialty expertise is critical for managing complex trials in systemic lupus erythematosus, rheumatoid arthritis, spondyloarthropathies, and other rheumatic indications.
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 with a CRO 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, cell and gene therapies, basket trials, and platform trials spanning rheumatology and oncology, as well as new approaches such as:
Immunomodulatory biologics
Genetically altered cell therapies
Gene transfer-mediated immunotherapies
Selective Kinase Inhibitors
Expertise with PRO scales directly related to pain in rheumatology indications, implementing strategies to mitigate placebo response, and patient training on proper pain reporting to enhance patient engagement and ensure high-quality data
Experience with complex composite outcome measures—including licensing, vendor collaboration, site/investigator training, eCRF development, and data integrity—improving data quality and trial efficiency
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
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
Strong Long-Standing Relationships
Medpace’s established relationships with global thought leaders, high-performing investigative sites, and site networks further strengthen recruitment and retention. This network helps facilitate strategic site selection, efficient start-up, targeted recruitment, and implementation of proven retention strategies—ensuring timely, high-quality enrollment that is key to the success of rheumatology programs.
Established Global Site Network
Strengthened by collaborative partnerships with our Flagship Sites and Centers of Excellence, Medpace offers Sponsors access to a global network of trusted, high-performing sites. With a deeply embedded global footprint, this network has proven experience delivering rapid study start-up, high-quality data, and reliable high enrollment.
“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.”
Maricor Docena, DO Medical Director, Mepdace
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.
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
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.
Medpace 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 extensive experience conducting global Phase I-IV rheumatology trials,supported by a cross-functional teamwith deep therapeutic expertise across a spectrum of indications, including but not limited to:
Explore our expert leaders who are shaping rheumatology research:
Brian Murphy, MD, MPH, FIDSA
Sr. Vice President, Medical Department
Board certified in infectious diseases, pediatrics, and internal medicine with over 25 years of experience as Medical Lead, Medical Monitor, or PI in Phase I-IV clinical trials, including 15 years at Medpace. An academic leader of multidisciplinary research teams across immunology, inflammation, and rheumatology.
Maricor Docena, DO
Medical Director
Board-certified internist and rheumatologist with over 10 years of clinical and industry experience. Experience conducting clinical research trials in an academic institution and as a medical monitor for phase I-III studies, including osteoarthritis, autoimmune connective tissue disorders, and advanced therapies.
Andrew Head, MD
Medical Director
Board-certified in internal medicine and rheumatology with 20 years of prior experience in clinical practice and as a clinical associate professor of medicine. 23 years of combined experience as Investigator or MM in Phase I-IV clinical trials covering a broad range of autoimmune, inflammatory and rheumatology indications.
Jen Lobert, MD, FACR
Medical Director
Board-certified in internal medicine and rheumatology with over 16 years of clinical experience in rheumatology, caring for a wide spectrum of autoimmune and inflammatory diseases. Unique subspecialty experience in the diagnosis and management of chronic pain disorders. Medical monitoring experience in Phase I-III global clinical trials involving cell therapies, monoclonal antibodies, and small molecules. Broad therapeutic area expertise in immunologic and inflammatory disorders.
Victoria Hernandez, MD, PhD
Medical Director
Board-certified rheumatologist with extensive clinical experience in rheumatic and autoimmune conditions. 15 years of clinical research experience at a large academic hospital in autoimmune conditions and over 8 years of experience in the industry working in clinical development.
Maxime Jeljeli, MD, PhD
Medical Director
Board-certified clinical immunologist with over 13 years of combined clinical, academic, and pharmaceutical research experience in immunomodulatoy approaches including CAR T cells, monoclonal antibodies, immune cell reprogramming and gene-modifying strategies. Extensive expertise in the pathogenesis and clinical management of immune-mediated diseases, including chronic inflammatory disorders, allergy, autoimmunity, alloimmunity, chronic infections and onco-immunology.
Jack Bleesing, MD, PhD
Medical Director
Board-certified in adult and pediatric allergy/immunology with over 25 years of experience in clinical and applied immunology and pediatric blood diseases setting, focused on clinical/applied immunology, immune-oncology, and advanced therapeutics, including precision therapeutics, drug repurposing, and cellular and gene therapy.
Laura Omoboni, MS
Sr. Executive Director, Clinical Trial Management
Over 25 years of experience in the CRO industry across a wide variety of therapeutic areas, including immunology and inflammation, rheumatology, neuroscience, and rare diseases. She has strong global experience, including in advanced therapies.
Jill Adkins
Sr. Director, Clinical Trial Management
An accomplished Clinical Research Professional with more than 25 years of experience working in the drug development industry across all study phases and a broad range of therapeutic areas, including immunology and inflammation, rheumatology, dermatology, respiratory, and neuroscience. Areas of focus include placebo response mitigation, accurate pain reporting, and training of site staff and study participants to improve data quality in patient reported outcomes.
Jackie Widmer
Director, Clinical Trial Management
20 years of global industry experience leading Phase I-IV studies across multiple therapeutic areas, including immunology and inflammation, rheumatology, cell and gene therapies, and rare diseases. She has 15 years of Medpace global project management in progressive leadership roles.
