Rare Disease
Agile Trials Powered by Advocacy Group
Relationships and Global Access
REV Clinical brings agility and focus to rare/specialized disease trials, where small patient populations, often complex advanced therapeutics, and challenging protocols demand the utmost attention. Leveraging trusted investigator relationships, advocacy networks, and our Global Velocity Network™, we accelerate enrollment, safeguard data integrity, and deliver reliable outcomes, helping sponsors advance therapies for patients with few therapeutic options.
Rare Disease
Clinical Study
Capabilities
REV executes rare disease studies end-to-end —from first-in-human through pivotal and post-market phases — with adaptive design, rigorous oversight, and multi-region operations that accelerate enrollment, uphold quality, and streamline submissions.
- FIH, Phase I & II studies
- Dose escalation studies (SAD/MAD)
- PK/PD interaction studies
- Biosimilar studies
- Phase III and Phase IV studies
- PMS studies
- Patient registry trials
- Concept designing, regulatory strategy drafting & FDA communications
- Confirmatory phase III studies
- Clinical endpoint studies
- Pilot studies
- Pivotal studies
- Human factor studies
- Significant risk (SR) studies
- Non-significant risk (NSR) studies
Experience with
Rare Diseases
With deep experience spanning therapeutics and medical devices for diverse rare diseases, REV delivers the flexibility, insight, and precision needed to execute studies across a full spectrum of trial types.
- Primary biliary cholangitis
- Sjogren’s syndrome
Advocacy Groups
Are Vital for
Success
Strong relationships with advocacy groups and key sites are essential in rare disease trials. REV leverages these relationships to facilitate effective patient identification and access, accelerate feasibility, and deliver meaningful outcomes.
Advocacy Group and Site Relationships
REV has established long-standing relationships with a range of rare disease advocacy groups and key opinion leaders serving various conditions. These relationships help us navigate the small patient populations being served by rare disease clinical studies. They also enable rapid site identification, foster strong engagement with Principal Investigators (PIs), and provide hope to patients with unmet medical needs.
Global Reach
We fully leverage our U.S., India, and Australia operations for rare disease studies, allowing sponsors to conduct global or regional trials cost-effectively and quickly. Given the small patient populations characteristic of rare diseases, the ability to efficiently tap large global patient populations is highly valuable.
Global Velocity Network Facilitates Strategic Market Access for Rare Disease Trials
Pre-Study Rigor Delivers Faster Starts & Fewer Change Orders for Rare Disease Trials
Expert Rare Disease Biostatistics & Clinical Data Management
Rare Disease Study Start-Up Services
Perhaps you are waiting for regulatory approvals, additional funding, or the completion of intellectual property filings. Our rare disease study start-up services can be offered as a standalone service, separate from the operational plan, so that you’ll be positioned to rapidly secure your first patient when you are ready.
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Regulatory, Quality & Compliance Excellence
REV Clinical’s dedication to excellence is grounded in rigorous process governance, compliance, and an understanding of the regulatory frameworks of the world’s leading regulators.
Let’s Move Your Study Forward
Interested in connecting with REV Clinical’s team of interdisciplinary experts to answer questions, take action on your RFP, and clearly define next steps?