Are you wondering if you should use an IRT (IWR/IVR) for your next clinical trial?
Perhaps in past trials, the IRT you used had limited features and just wasn’t worth the cost and hassle.
If this is the case, take another look.
During a clinical trial, site users record activities for subjects; a well-designed IRT can do these very effectively, saving both time and money. IRTs provide an array of options, often pre-configured, that enhance effectiveness and efficiency.
Here are seven ways using an IRT can help your next Clinical Trial:
1) Randomization: You may be able to find low-cost providers of simple randomization schedules. But for sophisticated statistical manipulations that help save time, product, and money, IRTs are the technology of choice. An IRT can easily manage:
- complicated stratification and cohort management
- adaptive randomization schema that permits statistically valid deactivation of failing treatment groups during a study
- dynamic/minimization approaches that create balanced randomization schedules on the fly based on the experience of the trial
- statistically supported forced randomization models which minimize drug issues by permitting sites to randomize based on drug availability
2) Shipping and Inventory Management: IRTs are designed to easily provide the status, tracking, and history of shipments and site drug inventory throughout a trial. Think about it – it this a function you want your team managing with spreadsheets?
3) Predictive Resupply: A good IRT system will offer the ability to manage a sophisticated set of variables to calculate site resupply schedules and quantities based on subject status. This helps to optimize drug supply efficiency and budget all at the same time.
4) Drug dispensation and titration management: IRTs are valuable for recording and tracking drug dispensation during a clinical trial, especially when the trial involves complex situations:
- dispensing by means of kit randomization scheme to maintain blind
- shipping kits directly to the patient’s home (decentralized trials)
- requesting just-in-time shipments; helpful when drug supply is limited
- managing subjects who need to take a drug hiatus or who miss dosing visits
- managing subject dose levels and enforcing titration rules
- performing dosing calculations and drug assignments based on subject characteristics such as age or weight, or based on batch characteristics such as potency or vial size
5) Monitoring temperature control, drug accountability, returns, and destruction: The IRT provides a cross-site, cross-country, centralized database in which to record and monitor the status of these important clinical trial logistical issues.
6) Earlier data entry: Because sites must use the IRT to carry out their trial activities (that is, the IRT provides a Subject ID at screening and a kit number at randomization or when recording a drug assignment visit) data entered into the IRT is available immediately. Data entry into the EDC system supporting the study is often delayed.
7) Integration with EDC platforms: A key requirement of an IRT is to be able to easily connect with the clients’ EDC in a manner that reduces the need for site coordinators to make duplicate entries in more than one portal and subsequent reconciliation.
About costs: IRT costs generally tend to remain at the low end of pharmaceutical technological requirements. Sponsors and CROs can control costs by being sure to ask for proposals from multiple IRTs, as there are significant differences, often attributable to variations in overhead.
According to our clients, Veracity Logic’s distributed network model places us squarely in the ‘value’ end of the normal range. In addition, changes during a trial are often made more quickly and more inexpensively with small IRT providers than with large ones.
Managing relationships: VL will help your team every step of the way – streamlining set up, 24/7 help desk, and more. This is especially helpful for smaller CROs or relatively new pharma sponsor teams.
Contact Us to start a discussion or schedule a demo.