As discussed on the Fisher Clinical Services blog, clinical supply professionals face many challenges in today’s world of clinical supply chain management. At the beginning of this year, I shared my thoughts with you on this subject matter through a series of on line articles. Part one looked at some of the industry and external pressures that organizations are facing. Part two drilled down some of the challenges that clinical supply chain professionals are addressing and how decisions will have a direct impact on potential for success. Part three provided some quick pointers and thought starters on how to overcome challenges in clinical supply chain planning. We reviewed a real world trial where there were significant challenges for the team in Part four.
We have definitely covered a lot of ground, but as we all know there is more to learn and to be done. To close out this series, I listed some parting recommendations and thoughts regarding effective and successful clinical supply chain management:
- Allow sufficient time for supply forecasting, sourcing comparator, blinding solid dosage forms, filing import licenses and other critical pre-study activities. If materials are in short supply and must be sourced globally, 6 months or more of lead time is required.
- Maintain constant communication between the operations and supply team for more effective study planning and prompt fixes to problems as they arise.
- Know the rules with respect to regulatory requirements, import licenses and other rules and regulations to avoid surprises that can derail a timeline.
- Be inclusive on paperwork, particularly import licenses to provide a buffer against mid-trial supply shortfalls.
- Avoid unnecessary risks and don’t make the mistake of assuming that commercial product will be available when needed. As one seasoned supply chain professional once put it, supplying a global trial “is not like going to the local drugstore.”
- Be realistic as well as economical. No sponsor can afford to waste resources, but having some overage is better than having patients out of drug or stopping the trial enrollment because there’s no more comparator in the cupboard.
- Expect the unexpected & factor in “what ifs” by ensuring that the supply plan reflects options in the event of a strike, tsunami, super storm or other emergency that could prevent material from reaching sites when it’s needed.
- Consider collaboration and partnering. Clinical supplies is a complex function that really can enable success or failure of your trial. We have come a long way as a function, but there is more to do. Collaborators or partners can have the knowledge and experience necessary to guide sponsors through the thorniest supply planning challenges.
- Measure twice, cut once. Repeat as necessary. A forecast is established on a set of assumptions at a specific period of time. Keep reviewing the data and make adjustments as appropriate.
- Remember that patients are the top priority. At the end of the day, every trial, every supply plan, all the execution and challenges (hopefully) go toward supporting a new therapy to change the lives of patients. We get to participate in providing improved options, better outcomes and a brighter future. Quite possibly the best reason to drive clinical supplies excellence!