Keep in mind the following features when selecting a unique supply chain solution for the clinical supply chain
Selecting a clinical supply chain solution presents unique challenges that vary greatly from generic supply chain management requirements. All too often companies try to adapt legacy systems or work with the leading supplier only to find out that their expertise doesn't extend to information systems used to manage clinical trials.
As a result, chief information officers (CIOs) typically face three scenarios: 1) facing the realization that the legacy upgrade doesn't work and starting the request for proposal process over again; 2) continuing with the leading supplier through years (and often millions of dollars) of customization; or 3) working with a specialist in developing solutions specifically for clinical supply chain management.
Regardless of the starting point, when selecting a software package that will be used for the clinical supply chain there are specific features that should be incorporated into the system to maximize benefit. CIOs can save considerable time and headaches if they keep these in mind as they consider a solution.
Features for the Clinical Supply Chain
The nature of investigational trials involves the constant uncovering of new data relative to the activity and effects of the medication. The net effect on clinical trial material requirements for one or more studies can oftentimes be dramatic, putting stress on the supply chain to react quickly to new demands. One way to mitigate the impact of these changes is the development of a flexible forecasting system. A system that allows the users to analyze various demand scenarios is an essential part of a proactive planning process.
Individual protocols are designed to demonstrate specific results of one drug versus another (or placebo) in various settings, using various dosage regimens. This makes it difficult to utilize systems built for commercial product manufacturing that are based on relative fixed bolls of materials and manufacturing/packaging processes. The variability of clinical research requires a supply chain system that allows for a flexible and easy-to-prepare bill of materials for individualized package configurations that may use a variety of processes to prepare the packages.
In order to comply with Good Manufacturing Processes (GMP) standards, a clinical supply system should be able to manage resources within the clinical manufacturing and packaging processes, using features such as recipe and process management, electronic batch records and resource scheduling. A clinical supply system that supports the printing of labels would also help ensure the ability to identify and control the product at every stage of the process — from receipt of materials, to dosage of the study subject, to destruction.
Clinical trials, like every other industry, have unique needs when it comes to choosing a suitable system. Today, for example, with the majority of clinical trials being blinded, the need for a system to handle randomized information is highly important. The system chosen should have the ability to either create or import randomization schedules, with the security controls to protect this important data.
Getting the right drug to the right patient at the right time is critical during a clinical trial. Oftentimes however, the clinical supply chain is prey to lags caused by the movement of paper documents from one actor to the next. One powerful function of a clinical supply chain software package should be the provision of electronic work routing and automatic e-mail notifications to users of tasks to be completed.
Various parts of the clinical supply chain are oftentimes controlled by separate systems from unrelated vendors. Ensuring that a chosen system has the ability to interface with other applications would help increase its effectiveness.
It goes without saying that any system managing inventory in the pharmaceutical industry must meet many standard quality assurance requirements and several crucial regulatory controls in the clinical supply process, this includes the CFR 21 part 11 compliance guidelines set forth by the Food and Drug Administration (FDA).
With these features in mind, CIOs will be well equipped to ensure the solution they select delivers the performance they need without the headaches and delays associated with costly upgrades and customization.
About the Author: Doug Meyer is vice president of Pharmaceutical Sciences at InfoPro Solutions, an information technology services company that focuses on the pharmaceutical and biotechnology drug development areas.
