Rare Disease and Orphan Drugs Development

Accelerate your development with the help of a proven partner to handle the complexities of rare disease studies and advance orphan drugs to market.

Urgent Needs. Innovative Solutions.

  • Find and identify specific rare disease patients to meet challenging orphan drug recruitment goals

  • Improve trial predictability through smarter study design 

  • Leverage the experience of rare disease experts and drive faster development

Photo of a Covance scientists studying a sample used in rare disease and orphan drug development.
Your Needs

Boost your rare disease patient enrollment.

Given the demands for specific patients within sparse populations, patient access presents an ongoing challenge for any rare disease trial. Don’t let this hurdle stand in the way of your trial’s success. With powerful analytical solutions such as Xcellerate® Clinical Trial Optimization®, access to information from LabCorp® patients self-registered for study participation and strong relationships with leading advocacy groups, we have integrated platforms to help you access and identify appropriate patient populations.

Work with us to help improve your study’s visibility and credibility to reduce recruiting risks and maintain your study’s momentum.

Leverage expertise. Accelerate orphan drug development.

Rare diseases are often poorly understood from a clinical perspective, highlighting the need for innovative study planning strategies. Our experts can help direct your trial(s) to yield more relevant results with an efficient study design that evaluates your desired outcomes and incorporates validated endpoints. Supported by surrogate markers and other innovative tools and approaches, such as imaging, you’ll be enabled gather key clinical data throughout the course of your trial.

With Covance as your partner, you’ll access a unique combination of dedicated therapeutic area expertise alongside comprehensive operational support to assist with every aspect of your global study. Together, we’ll develop robust study planning strategies that anticipate regulatory hurdles, navigate clinical complexities and accelerate your path ahead.

Maximize your commercial potential.

Even though orphan drugs address urgent unmet medical needs, it’s still crucial to understand your full impact on the market so you make the most of your investment. By evaluating payers, providers and patients, we can generate real-world, value-based evidence that helps you determine pricing and set your strategies for market access.

When you work with a team that combines medical, economic, scientific and operational expertise, your program is supported in multiple ways so you can not only reach your clinical goals but also enhance your potential for a higher valuation and return on investment.

Our Capabilities

Rare diseases. Common challenges.

Like any development approach, creating a drug to target a rare disease requires relevant experience in the therapeutic area and operational flexibility to handle a study’s unique challenges. We offer a wide variety of solutions—tailored for rare disease development—at every point from drug discovery to commercialization.

  • Access to more than 3000 assays, including relevant biomarkers, through Covance and the LabCorp Specialty Testing Group
  • Leverage 120 genetic counselors through LabCorp and take advantage of genomic stratification for patient selection
  • Trust in our proven logistical solutions to deliver >99% sample receipt within stability to maximize your sample yield
  • Unlock your product’s market potential with more than 20 years of market access consulting experience for rare and orphan products

Whether you’re running a smaller Phase I study or delivering a global Phase II-III trial, you can rely on our global capabilities and operational expertise in rare disease studies to fully meet your orphan drug program’s needs and deliver consistent results.

An experienced approach to advance your program.

Beyond helping you secure patients to meet your recruitment needs, we also offer deep experience with rare disease studies, with a track record supporting more than 50 indications and 103 studies across dozens of countries and thousands of sites. Pediatric-focused rare disease studies are even more complex, yet our team has proven successful management in more than 25 such studies worldwide.

Let our multi-disciplinary experts put their experience to work to advance your rare disease drug development program and transform obstacles into opportunities. Together, we’ll improve your potential for success and make a difference in urgent unmet medical needs.