Supporting Clinical Research in Autoimmune Diseases
Achieve quality results, meet deadlines, and maximize efficiencies by partnering with a full-service CRO that excels in designing and executing clinical research across a spectrum of autoimmune diseases. Medpace has the medical leadership, autoimmune trained staff, global trial experience, and site relationships to make your study a success.
As a global CRO with a therapeutic focus in Autoimmune Diseases, we:
- Have a thorough understanding of the complex conditions that cause autoimmune diseases, as well as the medical complications experienced by patients with these conditions
- Anticipate challenges and proactively navigate rapidly evolving regulations, operational complexities, and tight timelines
- Bring a depth of experience in managing clinical trials in autoimmune diseases across multiple therapeutic areas; Medpace’s scientifically-driven, therapeutically-focused operational model gives you cross-collaboration and insights from various medical perspectives
- Have strong relationships with KOLs and high-producing sites
Medpace has deep and broad experience conducting global Phase I-IV
trials across a spectrum of Autoimmune Diseases.
- Ankylosing Spondylitis
- Celiac Disease
- Crohn’s Disease
- IgA Nephropathy
- Inflammatory Bowel Disease
- Meniere’s Disease
- Multiple Sclerosis
- Psoriatic Arthritis
- Rheumatoid Arthritis
- Type I Diabetes
- Ulcerative Colitis
The Medpace Difference for Clinical Research in Autoimmune Diseases
- Global experience covering countries and regions with high incidences of disease
- Experience working with Sponsors developing biosimilars, combination therapies, and new approaches
- Strong relationships with key industry investigative sites and Key Opinion Leaders (KOLs) who specialize in recruiting patients
- Global Central Lab with safety and biomarker validation and analysis
- Imaging Core Lab brings expertise to support endpoints for autoimmune disease studies – a combination of imaging expertise and clinical trial experience ensures that imaging components are seamlessly integrated into the complex structure of the overall trial
- In-house medical expertise in related therapeutic areas provides additional support and insights
- Strong experience in rare disease/orphan indications and pediatric trials provides a depth of resources and expertise
Learn more about our integrated core laboratories
Integrated Central Laboratories
Medpace Central Labs provide consistency in methods and instrumentation across wholly-owned and purpose-built laboratories located in the US, Europe, China and Singapore. We offer safety testing as well as a wide range of inflammation and immunology-related biomarker assays (click here for full menu) and can quickly establish and validate novel assays as needed.
Imaging Core Lab Expertise
Medpace Core Lab provides comprehensive central imaging services including site assessment, instrument/site qualification and training and expert evaluation. Medpace has expertise with Magnetic Resonance Imaging (MRI) to support endpoints for studies. Our imaging and clinical trial experience ensures that imaging components are seamlessly integrated into the complex structure of the overall trial.
The Medpace Difference for Rheumatoid Arthritis and Psoriatic Arthritis Studies
Whether you need support at the planning stage of your trial (Pre/Post IND) or starting First-in-Human trials, Medpace has recent and relevant global experience providing you with valuable connections into our KOL network and deeply-seated site relationships.
Importantly, Medpace is able to converge our in-house medical experts across many therapeutic areas including Cardiology, Respiratory and Dermatology as well as challenging new approaches like cell and gene therapies to consult on the most effective and efficient study design.
As an added value, in collecting quality data at an accelerated rate, Medpace trials are supported by our in-house Imaging Core Lab and our global central laboratory providing safety testing and biomarker support.
Key Differentiators for Rheumatoid Arthritis and Psoriatic Arthritis include:
- Recent and relevant Phase I-III global experience
- Experience supporting biosimilars, combination therapies, and new approaches such as:
- Immunomodulatory biologics
- Genetically altered cell therapies
- Gene transfer-mediated immunotherapies
- Monoclonal microbial immunomodulation
- Selective Kinase Inhibitors
- Cross-over medical expertise in Cardiology, Respiratory and Dermatology delivers added insights and value
- Specialized in partnering with biotechnology companies who are developing novel approaches; which are often challenging and complex studies
- A well-profiled network of high-producing sites enables timely enrollment and high-quality conduct of trials
- CRO and imaging integration – a robust combination of imaging expertise and clinical trial experience ensures that imaging components are seamlessly integrated into the complex structure of the overall trial. We use a web-based image management system to analyze CT and MRI scans for confirmation of eligibility, safety and efficacy evaluations
- Global Central Lab supports a menu of validated biomarkers associated with RA/PsA and the ability to rapidly establish and validate novel assays as needed
- Flexible, highly-customizable ePRO solution that is fully-integrated into ClinTrak®, Medpace’s proprietary data management system