Rheumatology
Management
Capabilities
Global capabilities reaching
Europe and North America
OUR CORE SERVICES
Advantages of working with the leading niche CRO
PROJECT MANAGEMENT
PATIENT RECRUITMENT
Clinical Monitoring
Medical Monitoring
Pharmacovigilance
Biostatistics & Data Management
Study Design & Protocol Writing
Clinical Development & Regulatory Consulting
SITE SELECTION & MANAGEMENT
Rheumatology-Specific Vendors
Thanks to Innovaderm's adaptive approach, we sailed through our trial with ease!
“The team was not only knowledgeable but also innovative, suggesting effective approaches to optimize resources and streamline processes. Their flexibility and willingness to adapt were invaluable, enabling us to navigate challenges and pivot when necessary.”
Therapeutic Knowledge and
Experience in Rheumatology
+100
Established relationships with KOLs in 7 key countries in EU and NA
+1,000
Research sites by the end of Q4 2024
Leading Global CRO in Rheumatology and Dermatology
Why Trust Innovaderm for Your Rheumatology Trial?
INNOVADERM UNDERSTANDS
The Therapeutic Area
Geared with internal rheumatology experts with +70 combined years of experience
Common grounds between dermatology and rheumatology allowing us to apply our strong clinical, drug development, regulatory and medical know-how
The Process
Fully established European and North American operational teams and cultivated partnerships with sites
Robust ties with top enrollers ensure quality is never compromised
The Industry
Our organization is led by researchers, with a core focus on science and innovation that permeates every aspect of our work.
We are the only niche CRO in rheumatology and dermatology
As a strong and established mid-size CRO, we listen to your needs, provide you with a personalized approach, and we nurture long-time relationships.
2024 CRO Leadership Awards
4 Consecutive Years
Therapeutic Knowledge and Experience in 30+ Indications
Deep rheumatology insight to operationalize and execute
MEET SOME OF OUR KEY
RHEUMATOLOGY TEAM MEMBERS
Dr. Juan Ovalles, MD, PhD
Medical Rheumatologist Lead
Dr. Juan Ovalles is Senior Director in Rheumatology at Innovaderm. He brings 12+ years of clinical development expertise and a background in both general and pediatric rheumatology to the organization. A board-certified rheumatologist with a PhD in biomedical sciences, Dr. Ovalles excels in study design, medical and safety management, and scientific content creation. As a distinguished member of the Spanish Society of Rheumatology, his specialist knowledge spans systemic immune-mediated diseases, inflammatory arthropathies, juvenile rheumatic conditions, crystal-deposition diseases, osteoarthritis, and osteoporosis.
Eugene Uy, MD
Medical Monitor
Dr. Uy is a trained physician who specializes in rheumatology, osteoporosis, internal medicine and clinical immunology. With over a decade of experience in rheumatology research, Dr. Uy oversees global clinical studies.
Kristen Neely
Clinical Trial Manager
Accomplished CTM with 35 years of experience, Kristen has experience in all phases of clinical research. Her roles have ranged from coordinator and associate to mentor, trainer, and consultant, specializing in rheumatology. Kristen has been a part of Dr. Daniel Furst's team, a KOL in rheumatoid diseases.
Tiffinnie Paulson, BSc
Senior Project Manager
Tiffinnie Paulson is Senior Project Manager with over 19 years' experience in the CRO environment. She holds a B.Sc. In Business Management in Health industry and specializes in managing clinical trials for various conditions, including Rheumatoid Arthritis, Systemic lupus erythematosus and Oncology. Since 2005, Tiffinnie has excelled in project management, quality, and regulatory roles. She has managed large Phase I-III studies globally and is proficient in electronic data capture systems like InFORM and RAVE. Her experience includes preparing regulatory submissions and supporting regulatory board audits, making her an invaluable asset to the Innovaderm team.
Bhaskar Srivastava
Senior Vice President of
Clinical Development
Nimbus Therapeutics
www.nimbustx.com
Innovaderm has the right experience, the right team and the right philosophy.
"With the powerful combination of rigor & innovation that their team brings, we were able to execute our study smoothly and deliver results showing profound potential for patients."
CASE STUDY - SYSTEMIC SCLEROSIS
Study Characteristics & Challenges
Disease Focus: Systemic Sclerosis (SSc), including subgroups Raynaud’s Phenomenon (RP), Limited cutaneous SSc (lcSSc), and Diffuse cutaneous SSc (dcSSc).
Patient Demographics: 49 patients enrolled, with a diverse geographic distribution due to the rarity of the condition.
Study Design: Biopsy-based research requiring 2 or 4 x 3mm biopsies per patient; no treatment was offered as part of the study.
Recruitment Challenge: The lack of treatment provision made the study less appealing for recruitment, compounded by the logistical challenges of coordinating transport and clinic visits for distant patients.
Success Factors & Strategies
Timely Recruitment: Despite longer timelines associated with local academic sites and the institutional burden, patient recruitment was completed on schedule without any advertisement.
Low Discontinuation Rate: The study achieved a remarkably low patient discontinuation rate of only 4%.
Effective Coordination: Successful management of the logistical complexities involved in transporting patients from various locations to the clinic.
Results
High retention rate with a mere 4% discontinuation, our study design and patient management strategies have proven to be effective
Key Considerations For
RHEUMATOLOGY CRO
Expertise
ExpertiseCRO requires experienced staff in immunology and inflammation related diseases. For few diseases, it requires cross-functional expertise in areas such as dermatology & rare diseases.
Infrastructure
It is important to have a solid infrastructure, including a network of clinical sites and robust information systems, to conduct rheumatology trials effectively.
Regulations
It is essential for CROs to possess a comprehensive understanding and experience with the rheumatology endpoint guidelines set forth by the American College of Rheumatology. This includes familiarity with ACR20, ACR50, ACR7, DAS28, and other pertinent regulations.
Risks
Recruiting eligible participants may be more difficult due to higher competitive intensity. Shortage of rheumatology experts will be a key challenge.
Your Niche Rheumatology CRO.
Let’s Talk!
Connect With Us!
"As a strong and established niche CRO, we listen to your needs, provide you with a personalized approach, and nurture long-time relationships. Reach out to see how Innovaderm is expanding into rheumatology."
