Should you consider a global clinical ancillary management program?
The answer is simple. Do you want to conduct clinical trials to improve healthcare and treat patients – or manage ancillary supplies?
Clinical program managers often say they can do both. And sometimes they’re right. That is, they’re right until the studies scale beyond the line of sight for individual program managers, or when changing global ancillary complexities go beyond their level of knowledge and expertise.
When you are talking about a global program of clinical trials, most individuals will need help due to the evolving level of global regulations and increasing complexity of trials that requires a litany of ancillary supplies.
How can you tell your current clinical ancillary strategy is in need of an intervention? Keep an eye out for the following signs:
- Individual ordering does not fully capture efficiencies for ancillary supplies, which drive up material and logistical costs.
- Failed consistency in ancillary supplies as well as their management. This creates potential questions about data integrity in addition to supply chain challenges due to poor planning and lack of knowledge around the global supply of ancillaries.
- Oversupply—huge volumes can be ordered at once, only to overwhelm supply staff and fill up supply space. This leads to potential waste from product expiration and unused products, which often need to be tracked, returned, and redistributed or destroyed, all of which drive up cost and lead to inefficiencies.
Global clinical programs can easily cover several studies, dozens of countries, hundreds of sites, and thousands of patients. Such programs most likely will encounter one or all of the difficulties above with ancillary supply management. Central management of global programs can alleviate much of the burden on the clinical teams by having a team of ancillary specialists that are the global point of contact. Purchasing, distribution, regulatory, and compliance efficiencies are a few of the benefits of having a dedicated central ancillary program.
Often, individual project managers order their own supplies. However, for a robust supply chain, it is crucial to streamline the process, improve support and capture efficiencies. Here are some key steps:
- Consider central sourcing of your clinical ancillary materials and distribution to the sites. This will lead to a consolidated list of articles and can leverage volumes to gain pricing advantages. Moreover, it increases the consistency across countries and sites.
- Establish a team to manage the ancillary supplies for a program of studies as a whole, or outsource this task. Appoint a dedicated program manager.
- Use a web-based, country- and study-specific ordering system. This adds the benefit of supporting overall inventory management for the ancillary supplies.
- Train users (including creation of a user manual) on the established thresholds. Sites receive initial start-up ancillary supplies and then resupplied as-needed.
- Provide or use a third party provider 24/7 help desk to assist with ordering and answer questions.
- Develop and implement a program for equipment return and reissue—a program that could be managed and tracked centrally.
The use of a global ancillary program will instill confidence in the investigator sites that their ancillary needs will be met. This level of trust eliminates a lot of waste from inefficient supply chains and reduces time that the clinical team must spend dealing with supply issues. In addition, a single point of contact will drive efficiencies by eliminating wasteful non-value-added activities. Such an ancillary supplies program eventually increases the on-time delivery and assurance of supply. And most important – the assurance that ancillary supplies are being managed effectively frees up your clinical mangers to focus on the higher-value clinical concerns of the trial.
To learn more about how to achieve success in running global trials involving clinical ancillaries register for our Webinar “Ancillary Management - Keep Your Clinical Trial on Track”.