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The problem with disconnected systems

Traditionally, sponsors rely on several core systems to manage the lifecycle of clinical supplies. Forecasting and simulation tools inform and optimize production campaigns.

ERP systems support manufacturing operations and aspects of drug release, shipments, and inventory management. IRTs manage patient randomization and trial supply processes, such as drug ordering. Temperature management solutions help identify and manage excursions.

Four systems, each with some unique and some shared data, and each with an important role to play. As no one system holds all the data, the combined data are connected and co-dependent: no single system can work effectively in isolation. The interplay between systems is critical and leaves little room for error.

Unfortunately, siloed systems—often managed by separate vendors—make it difficult to marry up data to support timely and informed decision-making and optimize operations. When your data are not harmonized between systems, your problems can quickly escalate.

For instance, misalignment of data between systems can lead to inefficient inventory management. Inventory reflected physically in one system and digitally in another prevents sponsors from obtaining an accurate picture of supply, increasing the likelihood of inventory being inappropriately located to the determent of the trial.

This can create scenarios in which too much inventory is sitting doing nothing in a depot or at sites causing storage concerns and unnecessary hassle for clinicians. The outcome can be worse still if too little inventory is available at depots or sites, with the ultimate risk being that sponsors are prevented from randomizing or even continuing to treat existing patients.

Equally, limited visibility and connectivity between site activity and manufacturing can result from using standalone systems, which can pose a significant risk. In these scenarios, sponsors don’t have an accurate picture of their supply, yet the deeper disconnect means that they are also unable to establish one.

Where there is a disconnect between what is happening at sites and what sponsors are expecting to happen at sites, the risk of being unable to effectively complete interim and long-term planning (including building manufacturing plans) intensifies, along with the corresponding probably of materials being unavailable when needed.

Finally, without appropriate integration, temperature excursion data management is made infinitely more complex and time-consuming. This heightens the risk of unsafe product being provided to patients and places an extreme burden on sponsors who will need to demonstrate compliance and appropriate handling upon study completion.

When sponsors needed to pivot to accommodate the disruption of the pandemic, poor system integration made operating with agility and scalability unnecessarily difficult. As such, there is an increasing reluctance to continue managing these challenges, and the unnecessary risk and inefficiency they bring, and instead adopt system alignment and data co-ordination and consistency.

The argument for alignment and integration

Connecting the systems involved in the lifecycle management of clinical supplies closes the gap between the physical and digital supply chain. It creates an end-to-end mechanism of capturing, managing, and responding to data in real-time and promotes enhanced data integrity, as each system is working with the same accurate and up-to-date information. This reduces the effort required to manage trial data and lowers overall risk.

Let’s look at this in context. It’s typical for sponsors to lack visibility over actual drug usage at the site level, which impacts forecasting and requires manual intervention to achieve alignment between forecasts and usage.

Yet, through system integration, supply forecasts are automatically updated with real-time site usage. Access to real-time, quality data enables sponsors to make timely and informed decisions. It also reduces manual effort and facilitates better planning, which lowers the risk of both wastage and stockouts to deliver more patient-centric and cost-effective operations.

Another example is apparent during the inventory release and ordering process. Errors can occur when materials are released into an IRT system manually. These mistakes cause delays to shipments, in turn impacting patient recruitment and retention.

Where inventory management and IRT systems are integrated, a closed loop environment is established for inventory release and drug ordering, with a seamless flow of data from order trigger to order fulfilment and delivery. Alongside accuracy, speed is also improved via integration.

This approach saves time over traditional manual processes, which can take up to two days, while also eliminating the risk of manual processing errors. As the product is automatically released, and material instantly updated, better quality data are available to support a right first-time approach to delivering the right drug to the right patient at the right time.

With holistic visibility over trusted data, sponsors save time troubleshooting issues between multiple vendors, facilitating the faster release of materials, reduced impact, and more cost-effective operations.

Finally, where temperature data management is concerned, system integration mitigates the risk of material that has been involved in an excursion remaining available for patient assignment, as compromised supplies are automatically quarantined in the IRT. This approach improves patient safety and makes it quick and easy for sponsors to demonstrate compliance.

To streamline supply chains, deliver increased patient-centricity, lower risk, and promote timely trial completion, we can no longer afford to continue with the default factory settings of clinical supply technology. We must instead use this point in time as an opportunity to hit the reset button and establish unified supply chain systems that harness data to deliver increased performance. The insight and agility that results will be essential components for success in today’s post-pandemic clinical trial landscape.

About the Author

Abby Sener, Almac ONE Manager, Almac.