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IRT in Clinical Trials: Top 10 Solutions
Interactive response technology (IRT) in clinical trials
IRT in clinical trials refers to interactive response technology; an electronic system that is designed to help sponsors and sites with patient randomization and trial supply management. It is also sometimes referred to as randomization and trial supply management (RTSM), and there were previous iterations of similar technology that were referred to by other names. The first IRT in clinical trials came about as interactive voice response systems (IVRS) in the 1900s, which randomized patients, dispensed drugs, and resupplied sites through phones. IVRS evolved into web-based technology called interactive web response systems (IWRS)[1]. Some firms used systems based on both phone and web, so these systems were collectively termed IxRS[2]. These systems then expanded to include more features and modalities, collectively called IRT.
Through executing randomization protocols, making sure drug supplies are managed, distributed, and disposed of properly across sites, and even managing complex dosing regimens in more complex or adaptive trials, IRT systems also play roles in mitigating risk, ensuring statistical viability, supporting reporting and auditing, and improving the overall efficiency of trial operations.[3]
What is IRT used for?
Patient randomization: IRT can be used to screen patients entering the trial and randomize them into treatment arms. Leveraging technology for the randomization ensures allocation concealment and strict adherence to the randomization sequence.
Trial supply management: Another core function of IRT is managing the drug supply across sites in a clinical trial. IRT systems have various features to handle different aspects of trial supply management, from the manufacturing stage through to dispensation to patients. IRT ensures that the right drug, combination of drugs, or placebo is dispensed to each patient based on the treatment arm to which they are randomized.[4] It can also keep track of the drugs that are unused, wasted, or returned during the trial.[5]
Reporting and analysis: Real-time patient and drug supply data captured and stored in an IRT system is readily available to the study managers in the form of automated reports. Study managers can then use this information to review the trial’s progress and adherence to protocol, and make necessary adjustments if necessary. These reports can also be used during inspections and audits to demonstrate regulatory compliance.[3]
Difference between EDC and IRT
EDC, or electronic data capture, refers to a software tool that is used to collect and organize clinical trial data in electronic format rather than on paper. IRT in clinical trials only captures the minimum required data needed to carry out its functions related to patient randomization and drug supply management.[6]
Traditionally, the data from IRT systems had to be manually uploaded to an EDC system. Nowadays, the functions of EDC and IRT are commonly integrated, avoiding duplicate data entry and the need for reconciliation.[7]
What are the benefits of IRT in clinical trials?
IRT automates and centralizes the randomization process, eliminating potential errors associated with manual methods, and further allows the implementation of complex randomization designs that might otherwise not be feasible to perform manually. It also strictly controls sensitive data to ensure strict blinding, reducing potential bias and ensuring that statistical testing is assumptions-free.
IRT provides supply chain managers with real-time updates regarding product inventory and patient enrollment, which is helpful for maintaining supplies at each site that correspond to the enrolled patient population, preventing drug shortages and reducing wastage resulting from unused drug supplies.
Overall, interactive response technologies are valuable tools for managing the complexities of randomization and trial drug supply, as well as accelerating and reducing costs of clinical trials.
Top 10 trusted IRT (interactive response technology) vendors
If you are looking for an IRT provider to help streamline patient randomization and trial supply management operations in your trials, take a look at this handy list of tried and trusted vendors we have curated (solutions are listed in no particular order/preference). When assessing whether a solution is right for your organization or trial, consider some of the following questions:
What makes it stand out from the competitors?
Does the IRT system integrate smoothly with other systems, such as EDC and eConsent? Does the same provider offer these systems themselves?
Is the IRT system customizable? How quickly can it be set up/launched?
Does the vendor have an established track record of experience? Do they have a dedicated support team?
Suvoda IRT
Suvoda IRT offers rich and comprehensive functionality, with the core IRT features provided as building blocks which allows the platform to be easily configured to the needs of each unique study, regardless of its complexity. Suvoda’s product is designed to support the operations of complex, decentralized, patient-centric trials, and the IRT platform operates on the same architecture as their eCOA and eConsent solutions, providing a highly user-friendly, single sign-in platform optimized for seamless workflows. The advanced IRT functionalities are broadly grouped into trial logistics, patient logistics, and drug logistics, covering all aspects of RTSM operations and even integrating with temperature logs for cold freight/storage. Their technology is “low-code/no-code,” meaning that changes can be made without developer involvement, and has been used in more than 1000 trials across 80 countries.
May be ideal for: Sites and sponsors conducting complex trials and looking for a fully-integrated experience offered by a single provider that is trusted in the industry.
IQVIA Interactive Response Technology
IQVIA Interactive Response Technology is a part of the IQVIA patient engagement suite. It is designed to help execute site-based or decentralized trials with its highly flexible and optimized features. It supports everything from simple to complex randomization algorithms as well as novel trial designs.
IQVIA’s IRT accelerates study start-ups and protocol modifications with adaptable solutions and numerous self-service tools. Plus, it facilitates intelligent data integration to reduce data duplication and simplify the investigator and site experience. A suite of complementary solutions and over 400 turnkey integrations with other eClinical solutions enables greatly enhanced insights and reduced administrative burden.
Other solutions in the IQVIA patient engagement suite include eConsent, eCOA, IRT, and connected devices. These solutions can be used as stand-alone products or integrated and accompanied by expert services, offering sponsors nearly unlimited options for customization and configuration.
May be ideal for: Sponsors looking for a highly flexible and integrated IRT solution from one of the industry’s leading providers.
Medpace ClinTrak IRT
ClinTrak IRT by Medpace is an IRT software that can be customized to the exact level of functionality required by a particular clinical trial. It utilized web-based interfaces that can be globally accessed at any time by authorized personnel of each clinical research site. Each clinical trial is assigned a dedicated Medpace IRT project manager to coordinate all setup, programming, validation, and training activities.
ClinTrak IRT has already facilitated numerous studies across nearly 55 countries, having recorded almost 700,000 individual system transactions. It supports direct integrations with third-party vendors and depots for distribution and storage. Medpace offers other valuable ClinTrak modules – including ClinTrak Study Management and ClinTrak EDC – that can be easily integrated with the IRT system to further streamline operations and improve the trial’s overall efficiency.
May be ideal for: Sites and sponsors looking for a customizable system with dedicated customer support through the setup and training processes.
YPrime
YPrime IRT streamlines patient randomization and clinical supply management for any trial, from simple early-phase studies through late-stage trials with complex protocols. It also accommodates direct-to-patient trials or those clinical-supplies-only requirements. A noteworthy feature of this system is Power BI analytics which converts critical data into valuable status reports to facilitate informed decisions.
YPrime allows configuration with comprehensive, pre-validated modules to support various IRT functions. It can also be customized according to unique, protocol-specific requirements and integrations. This allows for significant acceleration of start-up timelines and quick builds. Its flexibility allows clinical trial sponsors and sites to cope with the ever-changing dynamics of the healthcare industry.[8] Sites and users can benefit from YPrime’s self-service tools, as well as YPrime’s 24x7x365 global technical support for both sites and patients.
May be ideal for: Sponsors and sites looking for a customizable solution who also place importance on strong technical support that is readily available for both sites and patients.
Medidata Rave RTSM
Medidata Rave RTSM claims to be the only fully pre-validated randomization and trial supply management solution that can be set up in only a few minutes. The Edit Live Design™ feature enables mid-study protocol design changes with minimized downtime and no change orders. Rave RTSM is built on Rave EDC; the default integration of these systems eliminates the need for replicate data entry and reconciliation, which saves costs and reduces the risk of errors. It also supports robust device tracking and accountability to mitigate risk and ensure regulatory compliance.
With countless years of clinical trial experience, Medidata’s Professional Services RTSM team partners with you every step of the way to optimize your RTSM processes. With full support in various configurations, from full build and execution to Live Study Management™, Medidata allows you to have “an experienced IRT SME playing the role of an unblinded supply manager during the trial”.
May be ideal for: Clinical trial sponsors looking for a customizable, fully integrated IRT solution offered by a leading player with an experienced support team.
Sharp Clinteract
Clinteract belongs to Sharp’s suite consisting of flexible, scalable, and efficient clinical trial solutions. This comprehensive randomization and clinical supply management solution aims to simplify even the most complicated randomization designs, visit schedules, and trial supply chains. It also eliminates the need for data entry duplication and reconciliation by allowing quick and smooth integration with any CTMS or EDC through API.
May be ideal for: Sites and sponsors looking for a highly-integrative IRT solution that focuses on user-friendliness and simplifying even the most complex trial operations.
Veeva RTSM
Veeva RTSM is one of the most user-friendly IRT systems available in the industry. It features a modular and highly configurable architecture that allows trial management teams to build trials (in an estimated 4 to 8 weeks) and implement mid-trial modifications (such as changing limitations on total subjects and activating cohorts) with exceptional speed. It supports all trial types, regardless of their complexity.[9]
Seamless integration with systems like EDC, eCOA, eConsent, and other eClinical tools facilitates a highly-efficient clinical trial ecosystem. Further, Veeva’s support team remains available at every step of trial setup and execution.
May be ideal for: Sites and sponsors looking for a configurable, user-friendly, and complete IRT system that offers easy integration with other tools, rapid trial builds, and full customer support.
4G Clinical Prancer RTSM
Prancer RTSM by 4G Clinical is a complete cloud-based IRT solution designed using natural language processing that brings flexibility, speed, and high-quality performance to clinical trials. Prancer’s most stand-out feature is its 100% configurability, which allows sponsors and sites to streamline complex trial designs with considerable ease. The system easily integrates with 4C Supply (4G Clinical’s supply optimization tool), allowing users to forecast changes in production and planning, compare IRT actuals against forecasts, and make changes in trials where and when required.
Prancer RTSM comes in various configurations:
- Prancer RTSM Lite: An affordable solution for early-phase or simple design studies
- Prancer RTSM Platform: Specialized for investigator-sponsored trials (ISTs)
- Prancer RTSM Rand-Only: Primarily for patient tracking, ideal for randomization-only studies
May be ideal for: Sponsors looking for a highly customizable solution that also comes in lighter, cost-effective configurations for certain simpler designs
Medrio RTSM
Medrio RTSM is designed to facilitate all study phases, sizes, and types. However, the factor that truly differentiates this IRT vendor from the rest is its team consisting of product, project, and subject matter experts. Medrio aims for completely transparent, engaged, and collaborative relationships with its clients, from the first consultation through to the end of the trial. They also offer complete decentralized clinical trial solutions that unify ePRO/eCOA, DDC, eConsent, and EDC with their RTSM.
May be ideal for: Sponsors looking for an IRT solution backed by attentive, full-service customer care.
Signant SmartSignals RTSM
SmartSignals RTSM is an easy-to-build/implement/manage system for randomizing patients and managing investigational product supply. With streamlined design and build approaches, it can be fully implemented approximately two times faster than other popular solutions – in one to four weeks, compared to eight weeks or more required to set up other RTSM. Protocol changes during the study can also be implemented extremely quickly.
Another core benefit of Signant SmartSignals RTSM is seamless integration with Signant’s full-spectrum evidence generation and clinical trial management solutions, like eCOA and clinical supply management. It also easily integrates with third-party providers of manufacturing solutions and electronic data capture (as examples).
Signant has more than 20 years of experience in clinical trials and has implemented over 2000 protocols in 90 countries. They have a product support team consisting of clinical science, biostatistical, business intelligence, and project management experts to guide you through RTSM deployment.
May be ideal for: Sponsors looking for an IRT solution that offers maximum visibility and control regardless of protocol design or complexity.
Conclusion
Choosing the right IRT in clinical trials is crucial for optimizing efficiency in patient randomization, blinding, and trial supply logistics. With many solid solutions available on the market, it is important to first define your organization’s or trial’s requirements and then study providers to determine which product matches your needs in terms of technological capabilities, configurability, integration with other systems, customer support, and pricing.