Repeatability of data and outcomes are some of the hardest things to achieve in research. However, independent validation of data and outcomes are cornerstones to preclinical therapy development. This is often achieved by working with Contract Research Organizations (CROs). The Food and Drug Administration defines a CRO as a person or entity that assumes, as an independent contractor with the sponsor, one or more of the obligations of a sponsor, e.g., design of a protocol, selection or monitoring of investigations, evaluation of reports, and preparation of materials to be submitted to the Food and Drug Administration. In addition to CROs, as a therapy moves toward clinical use it will need to be produced under current good manufacturing practice (cGMP) requirements before being considered for use in humans. Contract manufacturing organizations (CMOs), also called contract development and manufacturing organizations (CDMOs), are companies that provide drug development and drug manufacturing services in the pharmaceutical industry on a contract basis.
This deep-dive webinar will discuss the ins and outs of working with CROs and CMOs providing a clear view of the capabilities and the expectations when seeking their services.
This webinar series is sponsored by Regeneron.