Improving Site Efficiency with Automated Drug Resupply and Forecasting 

By Casey Doyle

Clinical Project Services | Group Leader | Almac Clinical Technologies

 

Clinical trials are complex undertakings, but the greatest operational burden often falls on the clinical sites. These sites are responsible for managing the critical components that drive trial success. Recognising these components as the building blocks of a successful clinical trial is essential. Sites are tasked with recruitment and retention, data collection, data integrity, regulatory compliance, protocol knowledge and expertise, meeting sponsor expectations, administrative tasks, ensuring appropriate facilities for diverse participant needs, cost management, and prioritising the safety, well-being, and ethics of participants. 

To navigate the complexities surrounding these tasks, it is crucial to ensure that sites are set up for success by implementing technological resources that allow them to structure their workflow, enhance data accuracy, improve protocol adherence, and proactively address operational challenges. 

With the availability of appropriate technology, such as an IRT system or an eClinical technology solution, clinical sites can focus more on the most important part of a clinical trial – the participants. Interactive Response Technology (IRT) and eClinical providers help streamline processes and workflows to reduce errors, administrative burdens, and potential interruptions in dosing, thereby allowing for greater patient engagement. In this article, we will specifically focus on how an IRT system can improve site operational efficiency through automated drug resupply and forecasting. 

How does IRT replace manual inventory tracking?

During the design phase of an Interactive Response Technology (IRT) system, the sponsor shares the clinical trial protocol with the IRT provider. This protocol includes participant visit schedules and dosing plans. The IRT system then programs these visits, making it easy for users to track participant progress in real-time as visits are recorded. 

The IRT system uses coded logic to provide the right treatment at the right time, based on the visit schedule and dosing plans. This real-time registration helps with accurate tracking of medication assignments. 

The IRT system also uses predictive algorithms to figure out when more supplies are needed. It looks at several data points, such as: 

• Current site inventory: How much supply is available at the site right now? 

• Supply expiry: When will the supplies expire? The system stops counting supplies as available inventory before they expire to avoid using expired drugs. 

• Site resupply strategy: The system can be set with trigger values depending on whether a site is enrolling many or few participants. 

The IRT system can also look ahead to determine if there will be enough supplies for future visits. If not, it will automatically place orders to ensure there is enough inventory. 

With IRT or eClinical technology solutions, these considerations are handled automatically using real-time data. There is no need for manual coordination or paper trails, making the process effortless and accurate. 

How do IRT inputs drive predictive resupply data?

Interactive Response Technology (IRT) or broader eClinical solutions enable real-time visibility into critical data inputs such as registered participant visits, kit replacements due to loss or damage, and inventory adjustments. These inputs directly influence the clinical supply status at each site.

With this real-time data, stakeholders including clinical site staff, monitors, Sponsors, and CROs can track inventory fluctuations and monitor supply shipments from depot to site. This visibility is typically delivered through IRT dashboards, which display current site inventory alongside in-transit and unacknowledged shipments.

Dynamic reporting further enhances this visibility by enabling users to review and forecast site needs. These reports are available in both blinded and unblinded formats, tailored to user access levels, and support a wide range of operational decisions. Key reporting features include:

• Inventory Summary: A breakdown of supplies in various statuses – i.e. Available, In Transit, Quarantined, Damaged, Missing, Expiring, Expired, On-hold for Relabeling, Accounted, Reconciled, Returned, Destroyed (at site).
• Numbered and non-numbered supply: Status tracking for individual kits.
• Site Shipments: Overview of site shipments and statuses along with information such as date ordered, date expected, and date acknowledged.
• Supply Projections: Generation of supply needs for the current date based off predictive algorithm plus inclusion of visit or rand projections.

Monitoring inventory changes closely reduces the risk of stockouts and enables proactive decisions to minimise overages.  This is especially important in trials with expensive or temperature sensitive drugs.

How does IRT ensure protocol adherence through system-driven logic?

To ensure the credibility of clinical trial research, Sponsors rely on clinical sites to adhere strictly to protocol. Interactive Response Technology (IRT) or broader eClinical solutions play a critical role in supporting compliance. These systems not only safeguard data integrity but also uphold quality by embedding protocol-specific rules directly into their validated configurations. This system-driven logic ensures consistent execution across sites, reducing variability and minimising the risk of protocol deviations

1. Kit-Type Rules

Ensure only protocol-approved kits are shipped and dispensed.

2. Blinding & Randomisation

Prevent bias and maintain treatment balance while minimising stockout risk.

3. Controlled Dispensing

Dispense only when needed per protocol visit, optimising inventory and reducing waste from overages or expiry.

Compared to paper-based tracking, IRT systems apply rules such as kit limits per subject per visit, resupply strategies, and expiry tracking. These mechanisms help to monitor and maintain inventory thresholds effectively. By setting these limits, IRT ensures that sites receive only the necessary amount of drug, which proactively prevents expiry events from interrupting participant dosing.

Additionally, IRT and eClinical platforms enhance regulatory compliance by generating detailed electronic records and audit trails.  This not only strengthens data integrity but also simplifies site inspections and inventory reconciliation at study closeout, minimising the burden of maintaining paper documentation.

How does IRT empower sites to manage inventory proactively?

When an IRT or eClinical technology is not used, sites must manually forecast and manage inventory for both current and future participants. This creates an endless cycle of manual demand planning which is both error-prone, labor-intensive, and assumes the risk of potentially under or over-stocking. If a site is understocked, participant treatments will be interrupted which can have negative implications for end-point evaluations but even more so for participants’ safety. If a site is overstocked, there is a risk of wastage which can have significant financial impact to the overall trial in addition to added up front cost to the sites coordinating excess return shipments with couriers. Utilising an IRT or eClinical technology for sites alleviates these pain points.

IRT or eClinical technology alleviates these burdens by enabling real-time visit tracking and automatic inventory updates. Sites can log visits and flag missing, damaged, or quarantined kits, which are instantly removed from available stock. A built-in predictive algorithm then replenishes the stock to meet the site’s needs, eliminating the need for manual calculations and orders for replacement supplies. As the site’s needs change, the resupply strategy can adapt accordingly, such as with varying enrollment activities or the elimination of certain kit types as participants progress through treatment phases. In the IRT, the kit type that is no longer required can be removed from the resupply strategy, preventing the management of unnecessary returns or on-site kit destruction.

How does IRT allow sites to better manage protocol evolution?

Over the course of a clinical trial, there are always possibilities for amendments for extensions, study design, procedures, etc. to provide further evidence and tracking of functional outcomes against the hypothesis. The Inclusion of an IRT or eClinical solution provides seamless supply coverage for sites without interruption as products are automatically replenished using the predictive algorithm.  When visit schedules, treatment arms, or enrollment thresholds are updated, the IRT system reflects these changes in real time. This enables sites to continue operations without disruption. Sites can maintain continuity in participant dosing, avoid manual recalculations, and ensure compliance with the latest protocol changes.

Final Thoughts:

Clinical sites are the backbone of trial success, yet they face significant operational pressures. Implementing an IRT or eClinical solution shifts the burden of manual inventory tracking, forecasting, and protocol compliance to an automated, real-time system, freeing site staff to focus on participant care.

With predictive resupply, real-time dashboards, and built-in protocol logic, IRT ensures sites maintain optimal inventory levels, avoid dosing interruptions, and minimise waste. It adapts to protocol changes and enrollment trends without disrupting workflow. Most importantly, it empowers sites to operate efficiently, compliantly and confidently, supporting both trial integrity and participant safety.