Orphan Drug Development for Rare Diseases

Rare disease companies rely on innovative partnerships to strategically develop their orphan drugs. Count on Covance to provide critical expertise to advance your rare disease drug candidate to market.

Rare disease companies can access the Orphan Drug Education Center for the latest webinars, whitepapers, case studies and blogs
Your Needs

Given the demands from orphan drug companies to find volunteers within rare disease populations, patient access and retention presents an ongoing challenge for any rare disease clinical trial. Don’t let this hurdle stand in the way of developing your rare disease therapeutics. 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 identify and retain appropriate patient volunteers.

Work with us to help improve your study’s visibility and credibility to create patient-centric solutions that reduce recruiting risks and maintain your program's momentum.

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

With Covance as your partner, you’ll access a unique combination of dedicated rare disease 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.

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 in an orphan indication. By evaluating payers, providers and patients, we can generate real-world, value-based evidence that helps you determine pricing and set your market access strategies.

When you work with a team that combines medical, economic, scientific and operational expertise, your program is supported by extensive clinical trial experience to enable you to reach your rare disease clinical trial goals and enhance your potential for a higher valuation and return on investment.

Our Capabilities

Like any drug development approach, creating an orphan drug to target a rare disease requires relevant experience in the therapeutic area and operational flexibility to handle a rare disease clinical trial’s unique challenges. We offer a wide variety of solutions—tailored for and dedicated to rare disease drug 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 drugs in development

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 drug program’s needs and deliver consistent results.

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