Custom User Roles …

Case Studies

Problem:

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?
Solution:

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.

Help, I need to add a Site but the study hasn’t started!

Case Studies

Problem:

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?
Solution:

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?

Errors in transfers to EDC

Case Studies

Problem:

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!
Solution:

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?

Complex Warehousing and Regional Depots…

Case Studies

Problem:

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?
Solution:

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?

Audit Trail and Access

Case Studies

Problem:

Tom Smith, a Study Coordinator at Site A in your clinical study, retired from the project three months ago. Due to a communication snafu, your clinical staff forgot to remove Tom’s name from the roster of active system users of the project’s IRT system. Two months later, your company’s QA group discovers this fact during their bi-annual production audit of the IRT vendor. From a regulatory perspective (not that they don’t trust Tom, honest!), they have to be concerned about the potential for unauthorized data changes…and about the fact that someone no longer assigned to the project could continue to view production data. How to quickly put all issues and concerns to bed?
Solution:

Veracity Logic’s IRT provides access to its robust audit trail in two ways: interactively, at the level of each item, and via a ‘global’ audit trail which maintains the cumulative record of all data changes that have occurred on a given project. The VLIRT® audit trail captures the old and new data, timestamp and date of change, user making the change, and a justification (required) for the change. A quick query of the global audit trail will reveal any data changes made by Tom Smith subsequent to his date of departure. The system also captures the last login date/time for Tom. QA can rest easy when it sees that Tom last logged into the system prior to his departure date.

Want to hear about other ways Veracity Logic’s IRT can help solve project problems?

Manual Shipment Requests: Help, I need more drug…!

Case Studies

Problem:

Your resupply algorithm for a particular Site has worked very well—until now. This month a generally low-enrolling site has inexplicably had a banner crop of new subjects. The site is running low on study drug. How do you get more drug to them fast?
Solution:

Veracity Logic’s flexible IRT system allows for unscheduled Manual Shipment Requests on demand. Authorized (unblinded) users can select the Manual Request option from the Shipments page and specify the precise number of each type of drug to be shipped. The IRT notifies the warehouse of the unscheduled order and warehouse personnel use the IRT to advise the site when their order has been sent. When the package arrives and site personnel mark the shipment ‘received’ via the system, the site inventory is updated within the IRT.

With Veracity Logic’s IRT, a project can have both Automatic and Manual Shipment Request capabilities available at a site level for whatever situation might arise.

Want more details?

Need to shorten startup time without sacrificing project quality?

Case Studies

Problem:

Your study has a hard startup timeline but there have been an array of delays and modifications on the science side of things. You not only need to make up time, you need to make some changes to the specifications for your vendors, including your IRT system which is already in validation…and you need to do it all without killing your timeline or sacrificing quality. What to do?
Solution:

We know clinical trials…change is a common phenomenon! That’s why Veracity Logic’s IRT was designed to provide maximum flexibility for just such situations. The VLIRT® system was built with an emphasis on two key strategies:

Validated CORE technology
Configurable project system modifications

Our validated CORE informs risk assessment strategies to enable focused, efficient testing and a high quality product in a timeline-friendly fashion.

Our base of easily modified, quickly accessed, protocol-specific setup configurations keeps the need for custom coding to a minimum in the development and change management of all project systems.

Want more to know more about how VLIRT can make your life easier?

Forced Randomization …

Case Studies

Uh oh, we don’t have that drug type on the shelf…!
Problem:

Clinical site A has been slow but steady enrolling subjects for your study, and the IRT resupply schedule has been working just fine, provisioning the site with just the right amounts of the two types of study drug used in the study. But an unexpected bolus of three eligible subjects has enabled the site to exceed its usual goals. Unfortunately, the randomization schedule has just assigned three kits of the same treatment group to the new subjects. Problem is, site A only has two kits of that group left in its inventory! You don’t want to lose the third subject. What to do?!
Solution:

Veracity Logic’s IRT accommodates a variety of randomization schemas including “Forced Randomization”. In the Forced Randomization scenario, the inventory management module of the IRT ‘knows’ that site A is one kit short on the assigned treatment group. The system automatically skips ahead in the randomization schedule to the first available kit in a treatment group that is currently available in site A’s inventory. It then assigns that kit/treatment group to the subject. This ‘forcing’ of assignment is balanced by the system in subsequent randomizations in which the ‘skipped’ kit/treatment group is assigned at the next study opportunity.

A special notification sent to specified users documenting when a Forced Randomization assignment has occurred.

In other words, Veracity Logic’s IRT gives you the power and flexibility you need to meet real-life scenarios with real-life solutions.

Summary Rollup Reports…

Case Studies

Problem:

Your drug supply depots are using up study drug faster than expected. You need to track down the problem. For one thing, you want to take a quick look at Subject Activities and see how many instances of unscheduled resupply of study drug have occurred in your study thus far, at all clinical sites globally, and, in particular, at Canadian sites, where the biggest problem seems to lie. How do you quickly get the information you need from your IRT?
Solution:

Veracity Logic’s IRT solves this problem with on-screen Activity Rollup function. A toggle on the Activities page brings up a summary report filterable by Country, Site, or Activity. Activity totals are provided at the Site, Country, and Study level (as defined for your project). The same summary data is presented for all other activities, including scheduled visits and unscheduled activities (such as Screen Failures, Early Withdrawals, and Unblinding).

Subject Rollup functionality, accessible by a toggle click on the Subjects page, is also a part of Veracity Logic’s standard offering. The Subject Rollup report provides at a glance the record of all scheduled subject visits that have occurred (and their dates) within and across subjects. This report is filterable by Subject Status, Site, and Country,

Want to know more about the powerful standard offerings of Veracity Logic’s IRT?

Reaching the Help Desk…

Case Studies

Problem:

Users of your IRT are having trouble remembering how to reach the Help Desk for system and project issues. Phone numbers and email addresses are provided in various documents, but somehow your study’s site users, project managers, and site monitors –globally!–don’t seem to be able to find them when they need them, or they waste valuable time looking. How can your IRT provider ease the pain?
Solution:

Veracity Logic’s IRT provides the Help Desk email address on the system login screen and again on a Help page within the project system, easily accessible from the Main Menu. Help Desk phone numbers for each Country are listed on the Help page as well. Users literally have help at their fingertips…just click the direct email link, or pick up the phone for more urgent issues requiring immediate resolution. If your study has an IVR (phone) component as well as a web interface, users can instantly reach the Help Desk by simply hitting the star key from anywhere in the call system. At VL, we figure the point of a Help Desk is to help!

Want to know more about the powerful standard offerings of Veracity Logic’s IRT platform? Choose Contact Us from the menu above for a demo!