微妙なアプローチに適している10の重要なIRT機能

Interactive Response Technology (IRT) plays a vital role within the eClinical technology ecosystem with regard to the handling of patient and material logistics. When designed and managed with patients, study teams and sites in mind, it can increase efficiency in clinical trials and lead to positive experiences for all parties concerned. However, handled last minute or without the right focus or expertise, it may present additional risks and challenges.

In many IRT systems, features may be missing or may not function with the degree of flexibility that study teams need to adapt to trial designs that call for quick adjustments. Some IRT systems allow users to make swift changes, while other systems require code changes that may pause the study while the changes are implemented. 

When looking at the experiences of busy study coordinators and other end users of IRT, the vast majority of their work focuses around patients. Therefore, it is important that functionality is incorporated with patients in mind—not simply to check off a list of desired features. The following considerations will help you to think more deeply about what to look for when selecting an IRT provider. 

Flexible Cohort Management

An IRT system that provides sponsors with full flexibility throughout a study is key to streamlining trial logistics—especially for particularly complex trials. Cohort management is a good example. For an early phase oncology study such as a Phase Ib/IIa, an IRT system that allows you to add cohorts, close cohorts, and change cohorts in real time is vital.

Suvoda offers flexible cohort management capabilities and a number of other functionalities that help trial teams in oncology (and other therapeutic areas) adapt faster. For instance, study teams can incorporate statistical analyses to automate cohort adjustments and make adjustments to dosage in treatment arms as needed.

Integrations with EDC, eCOA, CTMS, and Other Systems

Best-of-breed solutions integrated together could be the difference between efficient study logistics and a nightmare of delays, costly change orders, and failure at crucial points in a trial.

Suvoda has a dedicated integrations team to enable data transfers to flow seamlessly between our systems and other eClinical software. 

A great example is our integration with Veeva Vault Clinical Data Management System (CDMS). Suvoda and Veeva have a successful history of partnership in offering thorough integrations, which gives clinical teams the efficiency they need in their trial operations.. By integrating with Veeva’s CDMS, data can be entered in Suvoda’s IRT system and automatically transferred to the Veeva eCRFs in real time. This eliminates duplicate data entry at the sites, which cuts down on time spent managing data and leads to a better site user experience overall.

Dynamic Visit Scheduling

When evaluating IRT providers, it’s important to pick a system that can manage flexible visit schedules. This is especially true in oncology trials where patients get dosed in cycles instead of a fixed number of visits.

Using Suvoda’s dynamic visit schedule module, new visits and new cycles can be automatically added to a patient’s visit schedule as they progress through the trial without the need for a change order or re-validation.

Hands-on UAT Support

User Acceptance Testing (UAT) is one of the most critical milestones of any IRT system implementation. Suvoda assigns each trial a cross-functional project team with expertise critical to your trial’s success to limit issues throughout a trial’s lifecycle. We also provide UAT test script generation services as well as all data setup required to make your UAT a positive experience.

At Suvoda, we see UAT as not only an opportunity to test the system, but a chance to help train sponsor and CRO users on our technology. We maximize your time with us to build trust between our project team and your clinical team to establish a positive working relationship.

Smart Temperature Excursion Management

The IRT of today allows you to monitor and manage drug statuses entirely within its system to reduce error and processing times. Systems can now integrate with temperature recording devices and software to help you automate the temperature excursion management process. With the right setup, you can drastically reduce time and effort spent on excursion tracking and assessment procedures. 

Suvoda’s IRT system integrates with various depot vendors, temperature logging systems, and temperature management solutions to offer end-to-end visibility from depot to site. These integrations help site users by automatically deciding if temperature excursions have occurred during shipments. All site users need to do is upload the logger file into their external temperature management system via our IRT system. The drug IDs that meet or exceed the excursion criteria are marked as quarantined, damaged, or given a custom status of your choice in the IRT system. 

As a result of this status update in the system, email notifications are automatically sent to supply managers and other team members. Because this solution decreases process times and the likelihood of manual error, it also enables greater patient safety by reducing the likelihood that they will receive damaged IMP/comparators.

Intuitive Reporting Capabilities

Drug development companies are investing heavily in data analytics to generate valuable insights. IRT solutions that provide robust reporting mechanisms empower sponsors to enact end-to-end improvements by giving study teams easier access to data. This also allows them to centralize and formalize their data to make clinical teams more audit-ready.

IRT systems are valued for their ability to manage a lot of transactions, many of which are complex, multistep processes. As a function of so many transactions, a lot of data is generated. Your team needs full visibility into that data. 

At Suvoda we say, “It’s our system, but it’s your data,” and you need to have access to it in real time. We’re able to provide you this kind of access with pre-built reports to give you quick insights, as well our ad-hoc reporting tool that allows you to customize and save reports whenever you need. We also have made reports easily shareable to enhance collaboration between study team members.

Secure, Visible Drug Release Process

It’s important that you have full control and visibility into your drug release within an IRT system for compliance and quality. In Suvoda’s IRT, drug release is a configurable two-step process, with one user initiating the release and a different user subsequently approving that release. Electronic signatures may be applied at each step in this process. This workflow generates configurable email notifications, is documented in a drug release history, and is tracked in Suvoda’s 21 CFR Part 11 compliant audit trail. Suvoda’s drug release process provides a unique combination of real-time control by clinical supplies teams as well as transparency for the sponsor.

Comprehensive Drug Accountability

IRT should help study teams perform end-to-end accountability, reconciliation, and returns. In the Suvoda system this is a configurable three-step process. First, the site completes accountability down to the dose level, if required. Then, a monitor logs into the system to complete reconciliation, having the ability to flag any discrepancies and leave comments for the site. Finally, the site processes drug units for destruction on-site or for shipment to a destruction facility. This step includes an application of the site user’s electronic signature to check that drug is being destroyed or shipped back in a compliant manner. Each step of this process generates useful email notifications and can be easily viewed in one of Suvoda’s drug accountability reports, providing the sponsor with full traceability and audit-readiness.

Cross-functional Project Teams

A dedicated, cross-functional IRT team that understands the ins and outs of your trials is critical for smooth timelines from initial requirements gathering to closeout. More particularly, IRT teams that have specific therapeutic area expertise can ensure trials are equipped with flexible functionality to manage logistics.

Suvoda assigns a cross-functional project team to give sponsors a single point of contact throughout the duration of the study for better communication and protocol-specific expertise. This enables quality and reliability from beginning to end.

Versatile Roles and Permissions

An IRT system that provides flexibility to configure user roles and permissions can help to navigate changing requirements mid-study. The Suvoda IRT system allows an unlimited number of roles with an unlimited number of permissions. New roles and new permissions can be easily added into the system in real-time by the Suvoda team so everybody has access to what they need, when they need it.

Takeaway: Patient-driven vs. Function-driven Systems

Many IRT solutions on the market today are what we call ‘function-driven systems’ that have built a site’s user experience around the function, not the patient. But if you put yourself in the shoes of very busy study coordinators or clinical site nurses, they don’t work with functions every day. They work with patients. 

When looking at the various features of an IRT system, it’s most important to think about what will save time and money, and what will make running a complex trial easier for your study teams and site users. Ultimately, an efficient system that makes site users’ jobs easier can lead to better interactions with patients. 

That’s why when you select your IRT provider, it’s important that you select a patient-driven system that offers you more flexibility to ultimately serve the needs of patients. Learn more about how you can benefit from Suvoda IRT.

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