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Rare Diseases

Where we meet every challenge with confidence

With more than 20 years’ experience, we know better than most that rare disease trials are different from any other. What may present as routine steps can have hidden challenges.

So everything we do is about helping you to not only overcome them, but to do that efficiently and in a bespoke way that maximize outcomes.

Cmed people. Your partners

Our people around the world are highly qualified medical, scientific, regulatory and operational staff with extensive global drug development experience. They are supported by a network of KOLs and contacts.

Each one is committed to and cares about making the most difference to the design and effective operational delivery of your rare disease trial in every way we can with:

  • Expert consultancy on business, regulatory issues, medical and scientific objectives. We can also offer a detailed review of a trial’s operational aspects.
  • In-depth and up-to-date knowledge of the global regulatory environment and legislation. That includes clinical trial supplies issues and the most appropriate solutions.
  • A global network of investigators who have a track record of high enrolment enhanced by internal and external database searches.
  • Thorough operational experience in protocol development, management of rare populations and alignment of functional deliverables for seamless deliverables.

Ask us about:

  • Regulatory pathway selection
  • Patient enrolment and logistics
  • Country and site selection
  • Trial design
  • Medicinal product logistics
  • Data collection and delivery
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Our exceptional experience of designing and delivering studies for many rare diseases includes these indications:

Supporting Case Studies

Case Studies

Case Study
Rare Diseases: Phase II Primary Biliary Cholangitis
Case Study
Rare Diseases: Phase II Pediatric Study with Selected Metabolic Disorders
Case STudy
Rare Diseases: Phase I First-In-Human Study on Wilson's Disease

I wanted to extend my thanks from a DM perspective to the entire team for the effort and work you have put in throughout the year, to deliver something that is hugely complex and should have a big impact in the future. Although we have been impacted by COVID, you have all managed to keep some positivity and continue to drive forward at each timepoint and for this I am extremely thankful.

I would like to sincerely thank you for your commitment and hard work to support us for the finalization of the clinical part of the IND package. We appreciated that some changes arrived late but we really appreciated your flexibility to reach the target …. we are looking forward to working with you on the next steps.

Thanks to all of you for your hard work and efforts. The project is going very well and overall, the Sponsor is very happy.

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