Rare Diseases
Multidisciplinary expertise to bear on a broad range of rare disease states
Providing our clients with data-driven solutions and innovative analytical methods to support clinical studies and anticipate key regulatory requirements
The rare disease clinical landscape is tough to navigate, and running a successful orphan disease study requires meticulous planning and fluid problem-solving. Intego Clinical’s resourceful, adaptive data team helps our clients overcome every challenge while maintaining compliance with regulatory guidelines. We work on a variety of rare disease indications – including hematology-oncology – in early- and late-stage development.
Intego Clinical’s rare disease strengths:
- Our lean, versatile team brings multidisciplinary expertise to bear on a broad range of rare disease states
- We provide our clients with data-driven solutions and innovative analytical methods to support their studies and anticipate key regulatory requirements
- We pride ourselves on our ability to smoothly adjust protocols and work with atypical data sets
- We are comfortable implementing novel study designs to capture appropriate endpoints
- Our data visualization expertise is second to none—using various advanced tools, we can identify trends and deviations to minimize risk in small or incomplete patient datasets
Intego Clinical’s rare disease expertise
Today, over 350 million people worldwide live with one of 7,000 rare diseases, only 5% of which have a treatment. Although governments incentivize the development of so-called orphan drugs, undertaking a rare disease clinical trial remains difficult and risky.
At Intego Clinical, our highly educated team of statistical programmers, data managers, and other data specialists will help you navigate those risks and meet your clinical endpoints on time and under budget.
Working with a small number of patients with rare diseases and heterogenous medical backgrounds requires a biometrics CRO partner who is responsive, resourceful, and flexible. We are that partner.
Challenges associated with rare disease trials include:
- Slow patient enrollment rate
- Many patients with a rare disease have comorbidities
- Studies performed across multinational sites with a disparate patient population
- Establishing 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 such as PhUSE and PharmaSUG.
Experience you can trust
Pharma and biotech companies working in rare diseases need a biometrics CRO with deep expertise and familiarity with rare disease study design nuances in order to establish their trials for success.
Rare disease clinical trials are fraught with challenges regarding adequate patient recruitment and retention. Careful study design is necessary to avoid underpowered trials, but even with the right design, many rare disease studies face ongoing hurdles after launch.
The Intego Clinical team has worked on a number of rare disease projects, including complex hematology-oncology trials. With over a decade’s clinical experience, our regulatory insights will guide your studies to approval.
