Considerations For Your First Clinical Trial

After years of research and multiple rounds of funding, you are finally ready for the first phase of clinical trials. The competition is fierce and time is of the essence. Given the number of drugs that don’t survive all phases of development the odds are against you, but you are determined to succeed. And while you know everything there is about your Investigational Medicinal Product (IMP), you realize that it’s only one small piece of running a successful clinical trial.

For a small and emerging biopharma, moving into the clinical trial phase of development can be overwhelming. In-house resources tend to be focused on the science or on generating funds. The limited administrative resources serve in multiple roles where they do many things well, but aren’t necessarily experts in the areas essential to running a clinical trial. Engaging a consultant and/or a Clinical Research Organization (CRO) is often a first step. Their expertise can help with designing a trial, defining strategies for patient enrollment and implementing technology solutions to track progress.

Although helpful, it is important to understand that CROs do not typically manage the comprehensive clinical trial supply chain. What are the gaps? The new therapy needs to be packaged and labeled. There are supporting materials such as related consumables and possibly instruments or equipment that need to be procured for investigative sites. These ancillary materials and the IMP often require storage in regional hubs. Logistics expertise is required to ensure everything appears on time, in full and at temperature.