Eliminate the Disconnect in a Systems Approach


Applied Clinical Trials

Applied Clinical TrialsApplied Clinical Trials-03-01-2009
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Improving the quality and speed of drug development through integration and interoperability.

Drug developers thrive on production speed. Speed that is continually accelerated by the threat to remain competitive, regardless of pressures from generics and pressures to deliver an increasingly complex product portfolio to satisfy global demand. It is no surprise that many pharmaceutical manufacturers are searching for new ways to keep pace.

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One trend having an impact is the transformation of the IT landscape from disconnected, application-by-application efforts to a holistic, integrated systems approach. In the clinical trials process, for instance, clinical supply units are learning how to use valuable information derived from early development and testing to improve product quality.

In a 2008 article,1 Hussain Mooraj from AMR Research said: "AMR Research recently conducted a Web-based survey of life sciences manufacturers' struggle to enter a new phase of innovation with technology among various manufacturing segments for business growth strategies. The study found that life sciences manufacturers are 'looking to build the global end-to-end value chain, but current product supply competency is weak.' It also states that 'contract manufacturing is becoming a strategic part of the emerging business model...and companies are transforming traditional supply chains to demand-driven value networks.'"

In today's fiercely competitive market, discovering ways to leverage this information can prove crucial to winning the first-to-market race, and ultimately, capturing valuable market share. AMR's results show that life science companies "embarking on a demand-driven transformation are able to lower working capital costs, reduce stock-outs, improve perfect order, and have more successful product launches."

Independent systems

In recent years, drug developers have realized the benefits of applying automated technology to optimize various processes within the clinical supply chain. Because each process step within the supply chain presents unique challenges, companies have implemented highly specialized, stand-alone systems to best manage them.

This presents a formidable challenge for clinical supply departments that manage a multitude of systems from different suppliers. Perhaps, more importantly, it limits the value that manufacturers are able to extract from their automated technology because of limited information-exchanging capabilities and the time it takes to validate each system and train each employee.

One of the best ways to see how all of these disparate business and plant-floor systems impact the drug development process is by reviewing how they fit into the manufacturing and distribution landscape. Although integration between these systems seems easy enough, it poses one of the greatest challenges for clinical supply units because of the lack of standards or linking mechanisms. For example, Boehringer Ingelheim International, a German-based pharmaceutical company, was challenged with reducing the time it took to bring a product to market. All business processes and systems had to be regularly reviewed and streamlined to help ensure global compliance. The company determined that a clinical trial supply system using software and hardware technology with a common platform could be an effective way to meet the goal of producing clinical supplies faster, more efficiently, and less expensively. All of which helped the company to meet the competitive pace of the industry.

Enterprise resource planning (ERP) systems are some of the most prevalent systems in the commercial production area, offering drugmakers the ability to standardize business procedures and share information across the enterprise. In fact, many drugmakers are seeking ways to track clinical supplies using ERP so that they extract maximum value out of the system. However, because ERP systems typically are unable to gather plant floor information, let alone individual products, this has proven extremely difficult.

Another key component of a drug development facility is the warehouse management system (WMS) that manages the materials inside the warehouse and the production site. Although the WMS can track a product, batch or physical location, most commercial systems available today are unable to track individual items because it has many of the same limitations as an ERP system.

Other tools of the trade

Besides ERP and WMS, there are a number of other systems tailored to meet the needs of clinical supply units.

For example, randomization tools provide manufacturers with a random code to assign treatment to a subject during a blind clinical study. Because they use a complex mathematical generation of random lists and numbers for tracking purposes, randomization tools are seldom integrated with the clinical supply unit's material management system. Labeling tools also generally function independently and are used within the unit to assign distribution and patient safety information to each product.

Figure 1

When manufacturers use independent systems that are not integrated, tracking a product from one system to another or tracing a product from the clinical supply unit down to the patient is highly difficult and extremely costly.

Boehringer Ingelheim, for example, streamlined its investigational product supply chain using a common database across three sites to allow access to shared data and processes, including label texts, study data randomizations, and information on materials and batches.

Management systems

Systems with enterprise-wide integration capabilities specifically designed for the clinical trials process not only allow drug makers to alleviate complexity, they also help leverage clinical supply information.

In the case of Boehringer Ingelheim, the company was able to implement an integrated information architecture that allowed it to reduce operating costs while improving trial throughput and timeliness. The company also was able to better manage materials and traceability, along with also achieving compliance goals.

Fortunately for clinical supply units, some leading providers of automation and information solutions have developed clinical supply management (CSM) systems. Ideally, CSMs should meet all of the clinical supply unit's needs for drug manufacturing, packaging, and clinical site distribution on time and with minimal waste (see Figure 1).

When tightly integrated with the ERP system, the information captured by the CSM system can be leveraged across the enterprise. One method that leading clinical trial management solution providers are using to better integrate these systems is the Packaging Unit Code (PUC). The PUC helps the CSM system transform the product focus of the ERP system into meaningful information on a patient kit level. Through the use of integrated code randomization, clinical trial management solutions can generate a unique worldwide identifier for each packaging unit. The PUC functions as the central anchor, which then enables the CSM system to tie all other patient kit identity numbers back to the PUC.

For example, one patient kit can consist of seven blister strips that provide a daily dose of medication. The strips are packaged into a one-week box and then placed in a one-month box. An integrated CSM system generates a unique number for each packaging entity, which is tied to the patient kit throughout the kit's lifetime. One patient kit would be assigned seven identifiers for the blister strips, four for the one-week box, and one for the one-month box.

These specialized numbers are similar to serial numbers used in the discrete industry that help track individually manufactured parts for final product assembly, and can be linked directly to the ERP system. The product number tracked by the ERP system also is represented by a series of PUC numbers in the CSM. The blind patient number or randomized kit number also is tied to the PUC as well. Sequence numbers—the logical representation of kit production and releasing order—are commonly used within IVR systems and also are linked to the PUC.

Pharma specific

To help drug manufacturers identify and track the drug through all stages of development—including packaging, warehousing, investigator site distribution, and patient distribution—the PUC serves as a physical barcode or RFID on the clinical label. The PUC also is recognized by integrated voice response (IVR) systems that are used during the selection and distribution of patient kits.

Using the PUC as an anchor, the CSM system easily integrates with ERP and IVR systems to provide a single solution throughout all stages of a clinical study. Along with system integration capabilities, the PUC concept also promotes quality, efficiency, and speed within the clinical supply unit, especially during the packaging process.

Because the CSM system generates the PUC structure before the packaging activities take place, the information electronically controls the packaging process. This process is best described using the example given of the daily dosage blister packs. The CSM system is aware of individual blister strip placement in each respective one week-box and one month-box through the use of stored PUC numbers.

Once the contents of the blister packs are placed in the boxes, drugmakers check each box for accuracy. Many manufacturers still have quality assurance teams that manually check the boxes—a time intensive process with a high margin of error. Used in conjunction with RFID or barcodes, the PUC helps eliminate the need for manual checks by using an electronic check to verify that the correct blister is placed in the corresponding box. As a result, the packaging process runs more efficiently, in some cases increasing throughput by up to 50%.

The PUC also improves the quality and speed of the reconciliation process. If any part of a kit has to be reconciled, the system automatically locates all items within that particular container and identifies anything that has been destroyed. Using the integrated clinical trial supply system and applying the PUC capability, Boehringer achieved full tracking and tracing capability—from the raw material to the finished medication kits to the patient.

Destination integration

By combining the strength of CSM, ERP, and IVR systems, drugs can be quickly and efficiently dispensed to the patient. Fully-integrated CSM systems can provide drug manufacturers with the tracking and documentation needed to decrease production cycle and reconciliation times, as well as reduce the amount of quality assurance checks and resources needed during the trials process. Equipped with these capabilities, drug manufacturers can better meet the complexities inherent to the clinical trials process.

As the pharmaceutical industry evolves to cope with changing market demands and demographics, drug developers must look to establish open, integrated CSM systems that facilitate information sharing across the enterprise. Those who make the transition can expect to reap the rewards, including faster time to market, reduced business risk, and improved operational efficiency.

Martin Dittmer is life sciences product manager at Rockwell Automation, and Armin Lechler , MD, leads the life sciences consulting team for Rockwell Automation in Europe.


H. Mooraj, "Three Key Trends in Life Sciences Product Supply," knowpharma.com (2008).

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