Establishing CRO Requirements

Determining the requirements needed from your research partner for a clinical trial is the first step in outsourcing activities, regardless of whether or not you are working in a rare disease space. Finding a CRO that not only has the resources available but also has relevant experience in your indication is often one of the selection criteria. Finding a CRO that has specific experience in a rare indication can be challenging, to say the least.

In the absence of disease-specific experience, you should consider those with the following experience:

• A Higher Level of Therapeutic Area Expertise
  If you are developing a product for an extremely rare form of cancer, you will likely want to partner with a group that has significant oncology experience.
• Previous Experience Conducting Orphan and Rare Disease Research.
  Rare disease studies present a unique set of challenges, sometimes not seen in larger population indications. Finding a CRO that specializes in rare disease research will give you an advantage when encountering these unique difficulties.
• A Proven Track Record of Getting Rare Disease Drugs Approved by FDA
• A network of Rare Disease Experts That Can Help Augment And Enhance Your Development Plans