Selecting the Right CRO
Developing a product to treat a rare disease is a difficult undertaking. Often sponsors find themselves in uncharted territory with few (if any) previous studies conducted in their indication, limited data, and limited general knowledge about the disease itself.
Adding to these challenges is selecting the right CRO that has the knowledge, resources, and attitude necessary to conduct these difficult studies. So, how should you go about selecting the right CRO to assist you in the execution of rare disease studies?
Determining the requirements needed from your research partners for your clinical trial is the first step in your 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 your rare indication can be challenging to say the least.
Determine Overall CRO Characteristics
Rare disease research requires a more collaborative and attentive mindset of all stakeholders participating, including the CRO you choose to implement your clinical study.
The characteristics or corporate personality of your research partners can often be the single factor in meeting study timelines and budgets vs costly overruns and extended study duration.
Once you, the sponsor, sets the parameters and identifies a few CROs that meet your basic requirements, you should strongly consider those CROs who possess the right characteristics for success.