Worldwide Clinical Trials Rare Disease Overview

Source: Worldwide Clinical Trials

Worldwide Clinical Trials Rare Disease Overview

Founded by physicians committed to advancing medical science, Worldwide is out to change how the world sees CROs – in the best possible way. From Early Phase and Bioanalytical Sciences through Late Phase and post approval, we provide world-class, full-service drug development services. With infrastructure and talent spanning 60 countries, we execute predictable, successful studies with operational excellence. We never compromise on science or safety. We’re never satisfied with the status quo. We’re the Cure for the Common CRO.

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Creating a drug development program for the treatment of a rare disease is a huge task with a number of unique challenges. These can range from poor understanding of the condition’s natural history due to few investigators studying the disease, to the vast geographic dispersion of a small patient population and regulatory uncertainties. With approximately 7,000 rare diseases, each exhibiting diverse symptomatology, the key is expertise in rare disease clinical research, rather than disease-specific experience. You need a CRO with proficiency in these core functions:

  •  Accessing small populations as well as pediatric populations
  • Confirming and facilitating site GCP adherence
  • Ensuring site competency due to potential lack of GCP research conducted in specific indication
  • Exploiting innovative, efficient study designs
  • Implementing “participatory” research models
  • Managing supportive-care endpoints, especially neuropsychiatric and patient-reported outcomes
  • Minimizing subject and caregiver burden
  • Submitting INDs for novel or repurposed products
  • Utilization of patient advocacy group outreach

Worldwide delivers this expertise through our team of scientific, medical, operational, and regulatory staff, who all contribute unique skills to help our partners meet the special demands of rare disease clinical research.

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