Rob Smith: Perhaps the most striking and obvious change has been the ever-growing level of flexibility and sophistication in some IRT systems, which help to meet the needs of today's unique and complex trials. This mirrors the general trend in technology as a whole, but is also a reflection of the need for sponsors to maximise the effectiveness of each clinical trial. We have come a long way from those early phone-only systems that did basic randomisations and medication management. What has stayed static, though, is the necessity of understanding the clinical trial landscape.
Today's IRT systems aren't just another piece of software, but an integral component that not only supports a living, breathing patient's progression through a clinical trial, but also gives sponsors the necessary information to get that drug to market. The continued success of the best of them follows from their awareness of the special needs of the life sciences sphere and the regulatory oversight that comes with it.
IXRS 3 was born from over 20 years of experience in the IRT and clinical trial industry, and it comes with a team of experts on hand, all of whom are armed with years of experience in trials of all types and sizes. They can help to not only mitigate risk, but advise on optimising project design, assist with change management, and provide consistent support from beginning to end.
While some potential scenarios can be anticipated during the initial design of the project, others that arise during normal operations may not be considered. That's why the platform combines lessons from the past with an eye to the future, allowing for flexibility and customisation when needed, but ensuring consistency and stability over the lifespan of every clinical trial.
Taking advantage of the latest developments in software technology, the IXRS 3 platform can adapt to different build and design strategies, making it a rapid deployment solution in one case and the highly specialised, tailored product needed for a pivotal trial in another. Any trial profile, whether it involves one site or thousands worldwide, can be accommodated within the same platform. Regardless of the application, every trial on IXRS 3 receives the same industry-leading level of stability and service.
From my perspective, an IRT partner is invested in more than just simply delivering a software product and hoping that the available configuration points will accommodate the study's objectives. The IRT partner needs to be working to fully understand the sponsor's needs, expectations and practices beyond just the scope of a single trial - all while designing the right solution, and anticipating critical protocol and supply challenges. Quite often, there are different stakeholders within each sponsor organisation who might have specific needs or use cases that should be considered. Sometimes there may be a mix of legacy systems or other avenues of data flow on the sponsor side, and a good partner can help to ensure a seamless level of integration.
In evaluating a potential partner, a sponsor or CRO will benefit from digging deeper than just what they see in a product demo. A system that is too restrictive or confining runs the risk of making a trial work around it, rather than leveraging its benefits for efficiency and information management, so a potential partner should be able to explain not just how they deliver that product to the sponsor or CRO's requirements, but how they can support it throughout the life cycle of a clinical trial.
In addition, a partner can help the sponsor or CRO realise the benefits of information and operational consolidation across protocols, programmes and indications. Sometimes, the right IRT team may actually be better positioned to complete certain tasks more efficiently and at a lower cost than busy clinical and supply management staff from the sponsor or CRO. All of that requires a partner with a long term commitment towards the success of a sponsor or CRO. No sponsor or CRO wants to commit to a partnership only to discover that the flashy new technology vendor was little more than a start-up, fattened up for acquisition bait.
At its core, a trial's validity is dependent on a fair comparison between assigned treatments. Yet, the differing needs of running a global trial may require individual variation at the local level. In order to effectively balance consistency and flexibility, your IRT provider must be able to offer functionality and a level of service for your protocol that accepts and helps support local variability while still ensuring a consistent global approach.
This can include something as simple as having the IRT available in multiple languages, or supporting concurrent IP shipping and distribution strategies for different regional requirements. Data collection requirements, particularly in the areas of patient privacy, may also require the IRT to be structured differently depending upon the location of the clinical site.
Perhaps the most complicated, as well as the most important part, is the fact the IRT provider needs to be able to support all end users and clinical sites when they need assistance. The first step is offering an omnichannel solution for customer contact that allows those needing support to contact the IRT provider in the format and language they are most comfortable with using. But on top of that, an IRT partner needs to be able to react and deliver support in a timely manner to ensure that whatever issue is at hand is resolved and the site can continue using its platform without disruption.
One area that is increasingly emphasised in IRT, as well as across other technology applications, is the concept of user experience. Reducing obstacles between an end user and their goal is the hallmark of any positive user experience, and while the benefit to the user's overall satisfaction is obvious, the follow-through benefits to efficiency are not always so apparent.
Users who struggle with a product may not fully appreciate the potential benefits that it can offer and deliver, but when a user has a positive experience with a product, they actively look for ways to use that product to its full potential. In IRT terms, a UX improvement ensures a higher return on investment for the sponsor or CRO.
Another notable area of recent innovation is providing full traceability and accountability of supplies for a clinical trial. Compliance in this area can become a nightmare of inefficiency as staff often struggle to maintain complete records, leading to prolonged study closeout and an increase in overall costs. To prevent this, Almac Clinical Technologies created a streamlined solution called accountability and reconciliation tracking (ART), a native extension of IXRS 3 that can provide access to comprehensive features designed to give insight into chain of custody records and full visibility of investigational compound genealogy - from manufacturing to destruction.
IXRS 3 is a registered trademark of Almac Clinical Technologies.