Interactive Response Technology (IRT) helps clinical trial sites and sponsors manage both participant randomization and trial supply management (RTSM). What was once a manual, paper-based solution for participant randomization and supply tracking is now an automated, technology-driven approach that improves the accuracy, efficiency, and regulatory compliance within clinical trials.
Modern IRT systems use a web interface that supports the supply chain, integration, subject randomization, tracking, and clinical reporting. Supply chain optimization, data quality, and compliance with regulatory bodies require rigorous planning, monitoring, and documentation. Still, when done efficiently and effectively, they can result in considerable cost savings, trial accuracy, transparency, and enhanced participant safety. IRT systems provide an effective way to streamline and manage clinical trial operations. IRT is critical to ensuring randomization of participants & the treatment they receive is as per the protocol.
This article considers the key considerations when choosing an IRT system for clinical trials.
Scalability and flexibility
Clinical trials have seen a huge overhaul in recent years. In the wake of the global pandemic, trials are focused on global collaboration and patient-centricity to reach research goals and improve participant care, and clinical trials are using innovative trial designs and adapting approaches to achieve this. Therefore, IRT systems must adapt to different trial designs and sizes, with varying complexities, to comply with the regulatory requirements and operational demands of clinical research.
Clinical trials can range from small, single-site studies to large, global, multi-site trials. IRT scalability ensures that the system can handle growing participant numbers, increasing amounts of data, and expand operations without compromising performance or integrity.
Contemporary trials may use complex randomization strategies with multiple participant cohorts. The industry is increasingly considering innovative trial designs, including adaptive and master protocols, and patient-led supply chains as seen in precision and personalized medicine. Flexible IRT systems must be able to accommodate changes to study design and procedures in the face of protocol or site amendments, without considerable reconfiguration delay. Flexibility within IRT systems is particularly important when considering the fluctuation of trial demands: scalable and adaptive systems enable effort reduction, minimizing waste and carbon emissions, and saving both money and time.
Data integration and real-time reporting
Clinical trials involve multiple stakeholders around the world, including CROs, sponsors, researchers, supply chain and site staff, regulatory bodies, and study participants. As such, the need for enhanced collaboration and seamless communication has never been more important. Choosing an IRT system with seamless data integration and real-time reporting is key to streamlining trial operations.
Data integration refers to the collection and synchronizing of data from the various sources and systems within a clinical trial, ensuring that information from different stakeholders is collected, processed, and stored in a unified manner, compliant with governmental regulations.
Reporting suites allow for the ability to create charts and graphs from the data, providing quick insights into key trial and status information. Tailored reports including multiple trials deliver an aggregate view within a portfolio. Real-time reporting allows users to access real-time insights into drug availability, status, and batch expiration across all locations, with dashboards and alerts providing up-to-date insights, a critical element of enhanced decision-making.
First-time data quality
Data reconciliation takes time and effort and has the potential to delay trial results submission to regulatory authorities. If the IRT system is designed with the need for accurate & consistent data across all trial platforms as a principle of good RTSM design, it can reduce data reconciliation effort, monitoring effort & on-time submission/avoidance of delays.
Look for a vendor who designs the RTSM for first-time quality, including real-time guidance & data validation, plus self-service authorized data changes with a full audit trail.
An expertly designed RTSM, in alignment with protocol rules with clear unambiguous questions and messages for sites, can also result in improved compliance.
User-friendliness and customer support
A user-friendly interface ensures clinical trial sites, investigators, and participants can easily navigate the system without extensive training: this can reduce unnecessary delays and promote compliance. Fewer system errors not only ensure compliance with regulatory requirements but also maintain the integrity of data, which means a user-friendly and intuitive IRT system ultimately contributes to the successful execution of clinical trials. For global multi-site trials, user-friendly systems ensure that sites from different regions can use the platform consistently, reducing delays in trial progress and saving time and resources.
According to a study published in The Journal of Medical Internet Research, using digital systems in clinical trials aids recruitment and enhances participant engagement, accelerating clinical trial procedures. Solid participant engagement is the foundation of all successful clinical trials, and choosing a user-friendly IRT system can help facilitate this.
Look for an IRT system with comprehensive customer support. When you consider companies such as Perceptive eClinical, for example, not only do you get a comprehensive IRT system that will drive the success of your clinical trial, but you also get access to some of the industry’s most experienced randomization and trial supply management professionals, in addition to live support for site and users 24/7, 365 days a year. A dedicated expert with in-house system expertise and specific trial knowledge will provide support in all aspects of clinical trial management, from randomization to drug management and logistics, throughout protocol design, trial setup, and trial execution.
Choosing the right IRT system is an essential component of clinical trial success. By focusing on scalability, flexibility, data integration, real-time reporting, adaptability, user-friendliness, and comprehensive support, CROs and biopharmaceutical companies can streamline trial operations, minimize risks, and optimize participant safety, while maintaining the integrity of trial data.
To find out more, go to: https://www.perceptive.com/eclinical-perceptive/home/
Resources
The Journal of Medical Internet Research. Improving Participant Recruitment in Clinical Trials: Comparative Analysis of Innovative Digital Platforms. https://pmc.ncbi.nlm.nih.gov/articles/PMC11694053/
