In her most recent post on the Fisher Clinical Services Blog, Pam Osborne concludes her series on managing the clinical trial supply chain with a 10-step summary for overcoming the biggest challenges. Even if you're conducting "non-clinical research" that doesn't have a patient as the endpoint, many of the steps she outlines should be followed to ensure your valuable product is kept safe and secure.
The ultimate three takeaways from her series are:
- Keep your bases covered - know what exactly you need to do, what rules and regulations you need to satisfy, at every stage, and do what it takes to keep to the plan. To this end, communication couldn't be more crucial, and if you can't do it on your own, the right partnerships can help cover the gaps.
- Know what to expect - don't take unnecessary risks—don't assume the odds are in your favor and leave a variable to chance. Risk mitigation is very important, and you should never assume a best-case scenario in creating strategic plans.
- Remember the final goal - Osborne's final point—remembering that patients are the top priority—is without a doubt the most important in clinical trial supply chain management. However, investigators conducting biospecimen-based research must be equally mindful of the regulations, documentation, and risk mitigation regarding the materials they are working with, and the ultimate value of this element of their research to the patients who are waiting.
What are some of your top cold chain and clinical supply chain challenges?
For those of you working with biologics as part of your supply chain, below is an on-demand webinar you can watch to learn more about temperature requirements for biologics as well as ensuring temperature compliance through packaging, qualification, and process validation.