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Can processes used for 20 years in the manufacturing and retail industries work for us too?
The concept of supply chain automation has revolutionized manufacturing and distribution processes during the past two decades, and has resulted in dramatic ongoing business opportunities for large software and consulting companies such as SAP and Oracle.
Wayne R. Kubick
Often combined with related topics like enterprise resource management and customer relationship management, supply chain automation involves a holistic look at the overall manufacturing and distribution process from cradle to grave, ensuring that all raw materials and components arrive just in time from suppliers for processing in manufacturing plants, that finished products are shipped just in time to customers to be sold, and sold items are quickly replaced without maintaining large inventories on hand at any point in the chain.
Supply chain automation involves the use of advanced planning, simulation, and management software, and has spurred adoption of new technologies for tracking, such as barcode tracking and, more recently, radio frequency identification (RFID).
During a recent ski vacation, I was reminded of how ubiquitous technologies like RFID have become in everyday life. Some resorts now issue RFID ski passes that automatically charge me for each day I ski and track my progression across the mountain, perhaps to help monitor lift utilization and skier distribution throughout the resort. I'm simply another widget in their skiing production chain.
We typically think of supply chain management within manufacturing and retailing, where companies such as Wal-Mart and Dell Computers are known as best practitioners—continuously improving their overall processes not only within their own companies but with their suppliers and customers as well. Wal-Mart, in particular, was one of the first large-scale adopters of RFID. And when you place an order for a new Dell computer, this triggers a complex series of events where individual components are requisitioned and immediately replaced in the Dell supply chain.
The logistics field offers other role models: We can monitor the progress of our package in real time by checking the Federal Express or UPS Web sites.
In many cases the supply chain model is already partly in place—for managing the flow of experimental drug supply to the investigative site, perhaps using an interactive voice response system that includes inventory management and just in time resupply capabilities. But drug supply is only one of many requirements for conducting a clinical study.
If we considered a clinical trial as a manufacturing process, the inputs would also include investigators, patients, specimens, regulatory documents, data collection tools, and data. Suppliers include sites, regulatory authorities, oversight committees, labs, drug manufacturing, CROs, and technology vendors. Our finished product output is a clinical trial database and report, which is assembled into yet another product—a regulatory submission.
Without too much exercise of the imagination, we should be able to see several parallels with the supply chain management model applied in other industries. Yet few of us expect to see a trial run with the same clockwork precision as a Dell assembly line.
Since most pharmaceutical manufacturers are already employing supply chain management systems to produce drug products, it's tempting to imagine an SAP for clinical research. But implementing such a complex software solution is an expensive proposition even for the relatively finite and predictable links in the typical manufacturing supply chain. And the business case in clinical trials is unlikely to be very compelling for technology and consulting companies.
My friends at CDISC would say such a vision is possible if we just used CDISC standards, and CDISC together with the Gartner Group have claimed some incredible benefits if standards are fully adopted. But standards alone aren't sufficient to achieve the same savings and efficiencies as in supply chain automation—you also need exceptional supplier relationships coupled with planning, processes, controls, and technologies.
The very name implies a single, integrated view of the entire process with all the participants cheerfully humming together like a well-oiled machine. Not exactly the image that first comes to mind on most trials.
One key prerequisite involves managing superior supplier relationships, since supply chain management extends beyond corporate walls.
Some companies have already successfully applied customer relationship management principles to sites and investigators, but often retain an adversarial attitude in vendor relationships. In the supply chain model, relationships are negotiated for the long term, with a common, inter-dependent win-win benefit for both partners. This requires the utmost cooperation, trust, and transparency of information and integration of systems.
On the planning and management side, a clinical project manager could argue there's a great difference between managing product components (like disk drives, processors, and monitors in the case of Dell) versus investigators and patients in clinical trials. True enough, widgets don't have a mind of their own. And the excuses continue: The processes we must follow are too often paper-based, constrained by regulations or administrative bureaucracy.
And then there are the technologies we use—too many of them, each addressing different stages of the process, with too little intercommunication. The typical standalone clinical trials management system (CTMS) is a far cry from an integrated supply chain management system. These systems must seamlessly interconnect the systems of suppliers through customers to ensure seamless material and information flow and provide the management tools to ensure that all the individual pieces are running smoothly. Though we can easily purchase a 99 cent tune from our mobile phone in seconds, we can hardly imagine tying together a site's medical records system with our data capture system, and then triggering an automatic payment once a patient's e-CRFs have been received, with the entire end-to-end process actively monitored by a supervisory CTMS.
In our case, even the standards aren't quite all they're cracked up to be. Of course, we all know that it's much more complex to standardize all of the scientific variation involved in research. There are also too many different, often competing standards for different points of the process that don't quite fit together as well as we'd like—and most of these only cover some of our needs or aren't mature enough to be relied upon entirely.
And standards aren't of much use if they only exist in a printed document. They need to be part of an integrated, comprehensive system that manages the entire chain.
So, here are some of the key components we'd like to see in our imaginary supply chain for the clinical trials model:
And, naturally, all of it is validated as regulatory compliant all along the way.
Yes, I know: too much, too soon, too difficult, too busy. So maybe all of these pieces aren't quite there yet in clinical research—though some vendors may disagree. But since automated supply chains are ubiquitous in the commercial world all around us, and given the pressures upon the development community, why not?
Even if we can't just flip the switch on this hypothetical supply chain management system today, perhaps what we can do is begin moving in that direction by starting with a simple thought experiment.
Imagine that synergistic supplier relationships are in place for the long term. Imagine communication flowing freely between all parties so everyone knows exactly what is needed when—and getting it done so the assembly line continues to move smoothly. Imagine tapping into a "where's my trial?" system, showing which pieces are next to arrive and what possible obstacles loom ahead. And imagine plugging each new trial into the same system so that the process is predictable and repeatable.
Once the thought model is in place, we can start building the relationships and looking at the standards, processes, controls, and an integrated suite of technology components we need to manage that supply chain. Then the technologies will come.
Wayne R. Kubick is Senior Vice President and Chief Quality Officer at Lincoln Technologies, Inc., a Phase Forward company based in Waltham, MA. He can be reached at firstname.lastname@example.org