Veracity Logic’s VLIRT® web interface provides users with easy access to view data and a context-sensitive task menu for each record in the report. The task menu presents the users with only those options allowable for the selected record. For example, the task menu for a shipment that has been sent from the regional depot will allow a user to receive the shipment but will not allow the shipment to be sent again.
A variety of critical personnel involved in a clinical trial, including Sponsors, CROs, and Clinical Suppliers, need to keep track of the daily inventory of study drug and ancillary product available at each clinical site in the study. But the standard IRT inventory record includes data that unblinds. You need a fast way to provide site inventory status to those who need information, without a loss of study integrity. How to solve the dilemma?
Veracity Logic’s IRT has been developed over ten years of experience with issues exactly like this one in mind. Our system can readily provide both a blinded and an unblinded inventory view of the Inventory page of your project. You specify the users who will have access to each type of inventory view. Unblinded users will see the number of kits of each treatment type available at each site. Blinded users will see a ‘rollup’ report of the total counts of all kits (including both study drug and ancillary kits) available at each site. Administrative (unblinded) users will be able to toggle between the two views.
This is just one more of the many ways Veracity Logic’s IRT provides the power and flexibility you need to meet real-life scenarios with real-life solutions.
Oh my, not all demographics are created equal…
Your clinical trial has hundreds of subjects taking place in 32 countries. One of the best ways to help sites ensure accurate identification across subject visits is to require not only a unique ID for each subject but also a linked Date of Birth (DOB) and three-part subject Initials. Trouble is, some countries allow the capture of DOBs and some regard their presence in the IRT as a violation of patient privacy. Likewise, some countries allow the use of Initials…and some don’t. What to do?
Veracity Logic’s IRT was built with the capacity for demographic diversity in mind. By means of simple configuration settings, each site within each country can be set to capture Initials, or to replace Initials with dashes. Likewise, by simple configuration settings, each site within each country can require the collection of either a full DOB or, alternatively, an Age and Year of Birth.
By focusing on configurability rather than time-consuming custom coding, Veracity Logic’s IRT is easily modified to meet a wide variety of real-life study needs. No need to wrestle with systems that require ‘one size fit all’!
Interactive Response Technology solutions must be able to provide notifications in multiple languages as needed based on the countries in which a study is conducted. For IVR (phone) systems, voice prompts must also be translated and recorded in the needed languages.
We’ve got you covered! Veracity Logic supports over 40 languages including:
The IRT was originally configured to accept eligible subjects with a maximum age of 75. Midway through the trial, the maximum age was increased to 80…but only for sites whose IRBs had approved the increased age! What to do?
Veracity Logic configures a flag on the IRT Site Information page that allows Clinical Project Managers to designate which protocol amendment each site is authorized to use. The system adjusts accordingly, using either the 75 or the 80 age limit, for new subjects at each site. No need for one-size-fits-all! And Biostatisticians have the protocol information readily at their fingertips when it comes time for analysis.
Flexibility in accommodating changes … one of the most important aspects of vetting your IRT!
You’ve got a complicated study that, for ease of conduct, will require two special types of user roles not offered in your current IRT system. One is a kind of Project Observer who can access the same data your Project Managers can access, i.e., users and sites, resupply settings, screening limits, etc., but with a View-Only perspective. Your second need is for two types of Site Investigators, one with the power to unblind subjects in cases of emergency, one without that power. Your current IRT allows for only one type of PI role. What to do?
Veracity Logic’s IRT is built on an easily configurable platform which enables creation of new User Roles to fit study needs without timeline-busting custom coding. In the above case, the creation of a Clinical Project Observer with a specified set of permissions can be handled on a configuration basis via a User Roles table, as can the creation of a Blinded Investigator role. During study startup and throughout the trial, user permissions are managed by means of a user-friendly User Management module in the project system.
In other words, Veracity Logic’s IRT gives you the power and flexibility you need to meet real-life scenarios with real-life solutions.
For the sixth consecutive year, OmniComm Systems, a leading provider of electronic data capture technology, brings together industry thought leaders and life science organizations to explore and discuss how innovations in electronic data capture. Veracity Logic’s full-service Interactive Response Technology (IRT) integrates with OmniComm’s EDC system and many other mainstream EDC providers. Be sure to stop by our booth in …
You’ve got a study with 150 Clinical Sites globally and you want to be able to begin adding Sites to your IRT system as soon as they are enlisted (and allow Site Monitors to modify Site information as needed), but you don’t want Sites to be able to add Subjects until regulatory requirements are met. Once the study has started, authorized personnel should be able to add, modify, and remove Sites quickly and easily on an ongoing basis. How to do this?
Veracity Logic’s IRT solves the first problem by separating the Add Site function from the Activate Site function. Site information is added with the click of a button on the Sites page. At the desired point in the study startup process, the site is officially activated (by an authorized user). Once activated, clinical sites can begin to add subjects. Throughout the study, authorized users can easily access and modify site information as needed to keep site details up to date.
As part of the standard module, site information includes address, primary contact, phone and fax numbers, time zone, country, status as a clinical site or a depot, and whether the site will be resupplied using a manual, automatic, or predictive methodology. The warehouse supplying the site is specified, as is the maximum number of screened and randomized subjects permitted at the site.
Want to know more about the powerful standard offerings of Veracity Logic’s IRT?
Your study depends on reliable interaction between your IRT system and your EDC platform. But your current IRT provider has three times failed to successfully complete a transmission between the two systems…with no warning to you! In all three cases, the transmission error was caused by technical issues that were not in the IRT vendor’s control. Still, you need a way to solve the problem…fast!
Veracity Logic’s approach to third-party integration builds in error monitoring and correction processes. XML transmissions successfully completed are held in a SENT folder on the IRT server. Should the IRT server be unable to successfully transmit a document, that file will be moved into an Error folder and an email message automatically sent to IRT staff who can then take the necessary steps to address the issue and retransmit the file. If a snag at the EDC end is preventing data from being received, an email message is sent to VL’s staff so that resubmission steps can be taken.
At Veracity Logic, we know what real life is like, and we plan for it. Want more information or a demo of our system?
You’ve got a large, complex clinical study to be conducted at 120 sites in 22 countries around the world, with four treatment groups and two ancillary products required for the trial at all locations. Logistics of manufacture and distribution make it clear the most cost-effective solution is to have centralized warehousing in the US for two of the study drugs, in the UK for the other two study drugs, and that all ancillary supplies should best come from a warehouse in Germany! But your current IRT can’t handle the complex shipping and inventory management required for such an array. What to do?
Veracity Logic’s IRT has been designed to accommodate a wide variety of warehousing and distribution scenarios. For the case above, a central warehouse in the US and a central warehouse in the UK could directly supply one another with study drug, while each warehouse then managed the distribution of all four drugs to multiple depots positioned in EU and North America respectively. In addition, a regional depot in Mumbai (supplied by the UK warehouse) would feed clinical sites in India. A warehouse in Germany would be established to handle the distribution of ancillary supplies direct to all depots in all locations, for distribution to sites. The VL IRT Inventory Management module and Shipment modules would keep all the counts and details in sync.
Got a complex scenario for drug distribution?
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