While sponsors rely on efficient study design, planning, and execution to get their products to market, logistical challenges almost always make it difficult to ensure that sites are prepared for their patients. Keeping track of investigational product (IP), lab kits, equipment, and other supplies is a clinical operations problem that often results in missing study drugs, expired lab kits, lost biological samples, and delayed resupply shipments—all signs that there is a need for clinical supply chain management optimization.
This systemic issue impacts studies across all therapeutic areas and phases—over 80% of clinical trials are delayed more than a month. Clinical trial supply chain inefficiency is a significant underlying cause of these delays. A poorly managed clinical supply chain leads to cost overruns, compliance problems, increased patient burden, lost and unusable biological samples, and data integrity issues.
While many clinical trial software and data management solutions have been developed, they’ve all sidestepped a fundamental operational challenge that impacts every clinical trial stakeholder. This problem persists across site-based, decentralized, and virtual study designs, and is connected to all investigational product (IP), lab kits, equipment, and biological samples:
- No one knows what clinical supplies they have
- No one knows what clinical supplies they need
- No one knows how their clinical supplies got to where they are
At a high level, you are someone who needs clinical supply chain management optimization if you have trouble with:
- Compliance and protocol adherence
- Biological specimen traceability and chain of custody