Rare Diseases

Responsive biometrics support for rare disease trials

Multidisciplinary expertise to support a broad range of rare disease states

Rare disease trials demand flexibility, creativity, and close collaboration. Intego Clinical delivers biometrics solutions tailored to the unique demands of orphan drug development, helping sponsors design, adapt, and execute clinical studies with confidence. Our team supports rare disease programs across therapeutic areas and development phases, including complex hematology-oncology indications.

We combine data-driven methods, multidisciplinary experience, and deep regulatory knowledge to help clients overcome the distinct challenges these studies present.

What Sets Intego Clinical Apart in Rare Disease Research

A lean, flexible team with experience across multiple rare disease indications
Expertise in non-traditional study designs and complex statistical endpoints
Comfort working with small, diverse patient populations and atypical data
Proven ability to adapt protocols and strategies mid-study without sacrificing quality
Regulatory insight to anticipate submission requirements and avoid delays

Why Rare Disease Trials Require a Specialized CRO

There are over 7,000 known rare diseases affecting more than 350 million people globally. Yet only 5 percent of these conditions currently have an approved treatment. While regulatory incentives exist, orphan drug development remains one of the most demanding areas in clinical research.

Patient populations are small and often globally dispersed. Many participants present with comorbidities or highly individualized disease progression. These factors can result in slow enrollment, variable data, and ongoing protocol adjustments. Intego Clinical provides the strategic support and flexible infrastructure to meet these challenges head-on.

Common Challenges in Rare Disease Studies

Low enrollment and slow patient recruitment
Comorbid conditions complicating study eligibility
Trials conducted across multinational sites with variable populations
Difficulty establishing consistent and clinically meaningful endpoints

Leading
the Industry

92% of our statistical programmers have a Master's degree or higher.
Members of our team regularly present and share thought leadership at international conferences, like PhUSE, PharmaSUG, and numerous others.

Experience You Can Trust

Intego Clinical has supported rare disease trials for over a decade, including complex hematology-oncology studies and other indications desperately in need of treatment options. Our team of statistical programmers, data managers, and biostatisticians brings deep therapeutic knowledge and operational strength to every engagement.

We are known for our stability, consistency, and commitment to high standards. Our ongoing investment in professional development and thought leadership ensures that clients benefit from a team that is current, capable, and ready to meet evolving challenges in rare disease research.

Whether you're navigating small sample sizes, nontraditional endpoints, or complex trial logistics, Intego Clinical delivers biometrics support grounded in experience and built for agility.