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Are you equipped with an inspection-ready IRT?

In the race to improve speed and efficiency in drug development, clinical research studies have grown dramatically in the last decade in both numbers and complexity. Adaptive design, multiple cohorts, randomization and detailed dosing instructions have been driving factors in this increase as sponsors are looking to achieve more endpoints within a single protocol.

As companies continue to collect higher volumes of data in an effort to shorten the duration and number of trials required for submission, it becomes increasingly difficult for researchers to manage this information. This means the toolsets used to conduct studies are being relied upon more heavily. At the same time, the pharmaceutical landscape continues to shift toward large molecule compounds, where a unique set of challenges is emerging. Compared to small molecule drugs, biologics are more sensitive to temperature shifts, making supply chain management increasingly difficult.

Additionally, not only are there higher costs to manage when developing a biologic, but also the submission of a Biologics License Application (BLA) is subject to higher scrutiny by regulatory agencies. Therefore, biologics inherently require an increased focus on Interactive Response Technology (IRT) processes by regulators, as the data collected in an IRT is crucial to support a regulatory submission. This is why now, more than ever, the FDA is taking a closer look at IRTs and how these systems can directly impact patient safety and clinical trial integrity. The obvious conclusion is that the partner chosen to provide the technology to assist with these challenges must be up for the task.

In today’s pharmaceutical market, nearly 20 percent of total sales are biologics. By 2020, it was expected that they will make up slightly more than half of the world’s top 100 selling drugs. As we move toward the future, the industry will look to technologies like IRT to meet the needs of the trials that will bring these drugs to market. In the competitive pool of IRT providers that have developed during the system’s evolution, how many will be able to offer the technologies, design, and experience to do this successfully?

FDA expectations of an IRT system

The IRT system captures the broader features emerging within the market, such as electronic-reported outcomes, titration/dosing calculations, shamming (blinding of patient labs or other results), supply accountability, reconciliation, and returns. It can ensure the drug is at the right place, at the right time, and in the right quantities with the ability to respond to any changes throughout the course of the trial. The information collected and generated in an IRT system is at the center of some of the most critical aspects of a clinical trial, such as:

  • Integrity of randomization, implementation, and stratification of data
  • Dosing calculations and/or titration rules
  • Supply management aspects, such as control of expiring drugs, tracking of temperature excursions, and management of recalls

Beyond these, an IRT system improves the visibility that sponsors have into how sites are performing. For this reason, the FDA expects it to be used as a way to provide proper oversight of a clinical trial and to identify and remediate issues in a timely manner.

There are many vendors trying to use IRT in a very simplistic way and focusing solely on randomization and supply management. However, IRT saves time and money across many aspects of trial execution, and it has the potential to do even more. The use of analytics from IRT to support risk-based monitoring decisions in a controlled and objective manner is one of them. In addition, proactive identification of supply challenges or non-compliance with supply usage can save thousands or even millions of dollars. The mobile capability of IRT systems will enable even further uses, making the technology work better within a site or patient workflow than any other technology available.

There are few vendors that understand the challenges of clinical trials and the opportunity IRT has to enable these trials to run effectively. As the go-to provider for complex studies that have emerged flawlessly from the FDA’s first IRT audit, Almac has the experience, expertise, and integrity required to deliver the results necessary to bring your drug to the patients who need it.

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