Clinical trials are full of unknowns. Trials hinge on detailed planning in countless areas under the clinical supply management (CSM) umbrella: sourcing and procurement, temperature monitoring, logistics management, supplies forecasting, import regulations, and more. Given the potential for supply chain unknowns to delay or derail studies, sponsor companies — particularly those new to the clinical trial scene — can benefit from outsourcing its CSM to experts.
To meet the need for CSM expertise, Xerimis proudly introduces APEX (Advanced Protocol Execution).
APEX provides comprehensive CSM services, ideally as early as the drug formulation stage, though APEX’s modularity allows it to enter the equation at any point in the trial. Much more than project management, APEX CSM proactively guides and oversees every aspect of sponsor-related clinical supply activity at both US and EU/ROW levels, from protocol design and maintenance to program setup and rollout.
Katy Ostertag-Johnson, APEX Director of CSM Services, gives an example of how APEX can benefit sponsors: “With APEX, a less experienced client won’t have to figure out how to import investigational medicinal product (IMP) into Russia or Brazil on the fly. We’ll anticipate that need, engage the sponsor company or their CRO partner early, ensure ample time to prepare, and see that the import happens on time and within regulation — because we’ve done it before.”
Which points to APEX’s critical differentiator: Experience.
Capitalizing on years of collective clinical supply experience, the APEX team identifies challenges early, then strategizes, plans, and manages accordingly. This includes being able to recommend qualified vendors and partners as needed. Take Interactive Response Technology (IRT) platforms, for example. On their own, smaller sponsor companies may have never screened this critical trial component, or even know where to find prospects. APEX, meanwhile, has already reviewed options that are verifiably easy to use and can be mapped to trial specifications and objectives. Label translation and cold shipping are two more examples of specialized services where APEX can guide clients.
“Our clients can’t be expected to manage a clinical trial from a supply perspective if they’ve never done it before,” says Ostertag-Johnson. “Nor should they try to, given the stakes. With APEX, you’re not just enlisting someone to help you manage the trial. You’re getting experience and foresight you could only get through years in the industry. In most cases, partnering with us ultimately frees up financial resources that might otherwise be spent educating project managers or remedying mistakes.”
Why use APEX over a CRO-appointed clinical manager?
While a CRO may offer clinical supply management, sponsor companies can gain more efficiencies in outsourcing CSM to a contract packaging organization (CPO). “From my experience in working on the client-side, having supply management sit at the CRO adds an unnecessary layer to an already complicated process,” says Ostertag-Johnson. “When you manage supply through a CPO like Xerimis, you’re able to streamline those conversations about CSM and share a two-way flow of information with your packaging and labeling partner. This shared understanding, especially if APEX is involved early in the planning stages of packaging and labeling, study start-up, etc., helps mitigate risk and increases the potential for a successful clinical trial.”
Whether working backward from the target date for dosing first patient, or supporting a trial already in progress, APEX embodies the expertise to build studies, forecast supplies, and above all, navigate the supply chain unknowns.