Q. How can eClinical systems support end-to-end supply-chain management?
A. Maintaining clinical supply chain integrity is crucial to trial success. The supply chain can encounter many challenges, including more countries and more investigator sites supplied by yet more depots, thus increasing demands on the entire supply chain. Other issues may include inventory dispersion throughout the supply chain, expiry issues, myriad storage and temperature management requirements, and the implications of more complex study designs.
eClinical systems support effective, efficient, and flexible clinical supply-chain management to help mitigate these challenges at every stage of the product lifecycle, from release through final destruction. eClinical supply chain management (eCSCM) applications used in such systems typically include interactive response technologies (IRT) and web-based applications, such as distribution management systems and drug accountability applications, as well as mobile apps. The purpose of an eCSCM system is to add value through increased agility (i.e., build and post-build agility), improved usability, and enhanced flexibility, while reducing costs, mitigating risk, and ensuring compliance with all applicable regulations (1). Common features of effective eCSCM solutions include:
Clinical-trial sponsors need to ensure availability of the IP (in addition to comparators, ancillaries, and medical devices) required for study sites to successfully enroll study subjects in support of on-time trial completion. This is also crucial for navigating the various regulations and guidelines that maintain trial participant safety.
In clinical trials, eCSCM systems must be able to:
Additional requirements can include: Accommodation of eLabel requirements (2); implementation of needs-based product ordering; management of shipping and allocation expiry offsets, support of consecutive, concurrent, and alternate product allocations; and flexible reporting and forecasting solutions (including the ability to conduct pre-study and mid-study supply chain simulations) by study, depot, country, or site.
eCSCM systems typically support the following supply-chain management functions:
New approaches are also being used to better manage site and subject compliance with the goal of reducing storage and dosing errors. Strategies can include delivery of product storage, allocation/administration instructions, and compliance assessments, all delivered through various modalities such as IRT, short message service (SMS), or mobile app. These systems work together within a network:
Benefits of eCSCM
Maximizing the use of this technology confers the following benefits: Process efficiencies and automation drive decreased cycle times; accelerated decision-making through improved data visibility; reduction of data duplication; and additional effort as well as better enforcement of data quality.
Using the right eClinical supply chain management systems and network to manage the trial supply chain can greatly simplify the journey for sponsors, allowing for on-time completion of trials with reduced risk, better cost control, and an improved stakeholder experience.
1. ICH, Q9 Quality Risk Management, p20 (ICH, 2006), www.fda.gov/cder/guidance/index.htm, accessed Mar. 7, 2014.
2. FDA, Guidance for Industry, Standards for Securing the Drug Supply Chain—Standardized Numerical Identification for Prescription Drug Packages. Final Guidance (2010), www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, accessed Mar. 7, 2014.
About the Author
Kurt Lumsden is director, eCDS Client Services at PAREXEL Informatics.