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:
Agility—Allowing for rapid system deployment and change management
Scalability—A platform that can support simple and complex trial designs
Usability—Streamlined user interface with single sign-on and data aggregation
Flexibility—Accommodate basic as well as complex functionality requirements
Control—Effective tools for study, product, site, and subject management
Visibility—Insight into investigational product (IP) at each trial level (e.g., study, country, depot, site, subject, visit, pack)
Traceability—Current and historic information on IP/Investigational Medicinal Product (IMP) pack and component status, location, and disposition
Compliance monitoring—Through system error checks, reporting, alerts, and reminders to users/stakeholders to ensure on-time completion of user activities and supply-chain management (SCM) tasks.
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:
Prevent allocation of IP that will expire before use
Manage and replace unusable product
Support pooled supplies
Support direct-to-patient ordering
Maintain the study blind
Prevent depot/site stock-outs
Reduce the need for partial allocations
Update expiry dating throughout the chain of distribution
Minimize IP wastage, shipping frequency, and costs
Mitigate unplanned repackaging of additional supplies
Conform to site storage constraints
Integrate with other eClinical systems
Provide visibility of IP status, usability expiry, and disposition.
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:
Lot release for both uniquely and non-uniquely numbered supplies
QP management, including the ability for lots to be re-released if expiry is updated
Expiry management in tandem with study, country, or location updates
Site management, setting recruitment status, and supply schemes
Site inventory management--managing product by consignments or individual item
Supply strategy management (the ability to adjust floor and ceiling supply strategy levels as trial enrollment progresses)
Status management (managing product status including cold chain management)
Shipment ordering, receipt, dispatch, and proof of delivery
IP allocation and dosing
IP returns, accountability, reconciliation, and destruction.
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:
Basic eClinical supply chain management networks do not integrate activities such as manufacturing, storage, release, distribution, allocation, returns, and destruction.
Enhanced eClinical supply chain management networks utilize integrated eClinical systems to manage supply-chain activities such as release, ordering, allocation, returns, and destruction.
Optimized eClinical supply chain management networks provide further overall synergy through deeper integration and harmonization.
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.