Simplifying the Most Complicated of Clinical Trials
OVERVIEW: A long-term, Phase III randomized, double-blinded study can be challenging, let alone one that is being run in multiple countries with multiple dispensing units.
SOLUTION: At ISS we deliver expert level proficiency regardless of the complexity of a study. Our team proactively implemented a strategic management approach which allowed us to monitor each facet of the stud independently as well as in conjunction with one another. This enabled effective supply planning and utilization, which in turn reduced client risk and minimized waste.
RESULTS: The client’s targets were successfully exceeded and the study was completed with both recruitment and supply consumption at well under 10% variance from the forecast.
SYNOPSIS: The ISS platform provides an accurate way to gain real-time visibility into our clients’ supply and demand needs regardless of phase or study complexity.
Adapting to Changes in Trial Recruitment
OVERVIEW: A new client with a Phase III randomized, double blind trial wanted to transition to the ISS supply chain technology platform mid-study in order to evaluate whether or not they should manufacture of an expensive comparator compound. Recruitment for is study was slow, yet vital for analyzing the question thoroughly. To the end, the client chose to increase trial recruitment by 30%.
SOLUTION: We seamlessly transitioned the project to the ISS platform while planning for the go-ahead to evaluate the impact of increased trial recruitment. Using our proprietary platform that allows users to easily build new scenarios with existing information, we quickly generated updated planning forecasts for the client based on new demand as a result of the increased recruitment totals. Doing so prevented supply from losing value as it moved closer to expiration upon lengthening the recruiting process.
RESULTS: Once the project was transitioned to the ISS platform, we were able to quantify the impact of each change in terms of timing, costs and product needs for the client within moments. As a result, the client could plan supply needs accordingly while maintaining efficiencies.
SYNOPSIS: Unlike other companies, our software platforms are built to adapt to change and provide opportunities to enhance the efficiency of the clinical trial supply chain.
Managing Formulated Product with Ease
OVERVIEW: A client wanted to use our system to determine the feasibility of their manufactured product. They sought information regarding multiple studies that utilized bulk formulated product and pooled brite stock supplies. To do so effectively and efficiently, production time, quantities and depot forecasts needed to be accurately established.
SOLUTION: Our team began planning and forecasting for API through formulated product needs in order to generate studies based on the client’s manufacturing schedule. They quickly produced various planning scenarios to expose the precise impact that inventory product changes would have on depot demand, trial start dates and recruitment assumptions.
RESULTS: Batch production forecasts were easily accomplished from the compound level, which meant that the client could make accurate decisions from a portfolio perspective. This, in turn, helped with prioritization of supply and provided the client with a comfort level to move forward with executing studies accordingly.
Additionally, the client’s depot demand was accurately met, thus eliminating unnecessary costs and inventory waste.
SYNOPSIS: ISS enables users to proactively balance several pieces of the supply chain puzzle, avoiding risk to the supply chain while allowing clients to revise and manage production time and quantity forecasts.
Optimizing Plans for Multiple Dosing Scenarios
OVERVIEW: A pharmaceutical company sought to plan a study with multiple dosing changes for an adaptive trial. In this particular case, the dosing changes had to be considered after the interim analysis point. The client also specified a need to restart the study without losing time or wasting supply, thus making the pre-planning process particularly vital.
SOLUTION: Typically, such an interim analysis period is approximately six weeks. Without the use of simulation, however, six weeks would not be enough time to complete a full scale packaging release. Using the ISS system, we were able to simulate the different dosing scenarios at a significantly faster rate than other platforms would require. This gave us the ability to plan for upcoming demand and production while providing peace of mind to the client upon restarting the study.
RESULTS: Upon assessment of the interim analysis and a decision from the client on dose, we were able to utilize the system’s effective simulation to successfully implement the new plan within the required timeline. We evaluated the four active doses and the team was able to restart the study quickly using two new doses.
SYNOPSIS: With a build-in capacity to modify and adjust a study based on varying factors such as multiple dosing options, ISS clinical supply technology provides assurance and quick response.
Resolving the Complexity of Scheduled Drug Studies
OVERVIEW: Scheduled (also known as controlled) drugs are strictly regulated due to the potential for abuse and addiction. Therefore, clinical trials of such substances often require navigating unique logistical challenges to ensure compliance with stringent regulatory requirements. These challenges include clinical considerations such as the precise management of the drug supply chain.
All persons and organizations responsible for testing, manufacturing, importing, exporting, distributing or dispensing a scheduled drug must apply for and obtain a prior authorization from the U.S. Department of Justice's Drug Enforcement Administration (DEA). Additionally, each activity involving a controlled drug requires a separate registration from the DEA, which must be set-up with the appropriate quantities required during a 60 period and must be replaced every 60 days.
In this instance, a client requested to use our forecasting technology to track the use of a scheduled drug which they needed to be imported into the United States from Canada. The complexity and vigilance needed to meet the regulatory requirements for this study required efficient, detailed forecasting.
SOLUTION: Our team put details of the drug supply and import schedule into the ISS platform and watched them carefully. We were then able to successfully simulate demand to keep import overage to a minimum.
We also employed our forecasting tool to develop a precise DEA tracking process that prevented supply shortages at designated sites and ensured that all prior authorizations remained compliant.
RESULTS: By utilizing our clinical supply technology, the client was able to keep import overage at less than 10% while also ensuring the prevention of drug supply shortages.
SYNOPSIS: While a study of a scheduled substance could significantly increase the complexities of supply chain management for other companies, the ISS platform accurately simulates supply and demand of controlled substances, reducing concern over meeting compliance standards.
Minimizing the Expense of Comparator Studies
OVERVIEW: Comparator studies examine how an experimental drug product matches up to an existing drug product in the same class when measured on bioequivalence, safety and efficacy. Because supply of both the experimental drug and the existing drug must be managed, comparator studies tend to be more intricate and more expensive than placebo-controlled trials.
A client requested to use our forecasting technology to simulate the use of an expensive comparator drug across a Phase III trial to avoid waste and keep expenditures to a minimum.
SOLUTION: The ISS team got to work building the study, ensuring the ability to support complex protocols and make rapid changes as needed. By carefully tracking the simulation of predictive usage against actuals, we tailored the IWR logic to the values represented in our models.
RESULTS: We were able to save this client over $1 million USD by utilizing our technology to allocate drug supply to testing sites accordingly while avoiding waste.
SYNOPSIS: Though companies can feel uneasy when faced with the expense of managing both their experimental drug and a comparator drug, with the ISS technology they can rest assured that there will be no supply concerns and funds will not be squandered.