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