Putting Clinical Study Control Where It Belongs

By Noah Cotes, Project Manager at Veracity Logic, LLC

 

In the fast-paced world of clinical trials, a lack of information and ability to adapt will leave you in the dust. To address this,  Veracity Logic advocates a “study-team-centric” model of clinical trial execution, where our system facilitates putting the study team in control.

To be team-centric means to consider the basic needs and realities of study teams – including Clinical Project Managers (CPMs), Monitors, and Site personnel—with an eye on ways to promote ease, clarity, simplicity, and workability.

Since Veracity Logic specializes in Interactive Response Technology (IRT/IWR/IVR/RTSM) systems, we look here at team centricity as it can be applied to the world of IRT. Below are four quick examples of a “power-to-the teams” philosophy as applied to specific IRT functions:

 

Managing Sites and Users

Project Managers can manage the addition, activation, editing, and deactivation of study sites and system users, either manually or via easy imports. The process is simple, so there is no need to involve technical personnel or vendors to maintain or make changes. And study permissions can easily be reconfigured to distribute this capability to other user roles – for example, the function to deactivate users can be given to Site Monitors to free up time for Project Managers.

Managing Resupply Levels for Sites

Changes that dictate the shipment request triggers can also be managed by Project Managers, either manually or via easy imports. For instance, if a site is enrolling faster than expected, Clinical Project Managers (or Site Monitors, if given access) can increase the amount of drug to be maintained at the site  and/or the level which triggers shipment requests for the site — all without having to involve technical support staff.

Managing Cohorts

If the study has cohorts, Project Managers can manually control cohort limits and enrollment. Study managers can open and close cohorts as needed throughout the study and increase the maximum number subjects allowed to enroll in  a specific cohort on their own. These updates are applied automatically so as soon as the cohort limit is changed, it becomes active throughout the entire system allowing for real-time updates. You can manage your VLIRT® system as your study requirements change.

Custom Reports on Demand

Conventional systems focus on providing ‘canned’ reports, which must be adapted for each study.  Custom reports and ad hoc queries can mean time delays and additional costs. By comparison, a team-centric approach to reports puts control in the hands of the study team, making answers available quickly and at no additional cost. Each data table in our VLIRT® system allows a one-button .csv data export, which then permits the quick manipulation of data in programs like Excel. These are real-time reports and can be created for Subjects, Activities, Kits, and Shipments. If the study has an ePRO  (electronic Patient-Related Outcomes) or eDiary component, the diary compliance pages can even be translated into real-time reports.

 

By giving the project team the power to manage sites, users, supply levels, and cohorts as well as the ability to quickly pull reports, the VLIRT system can make it easier for them to get the answers they need.

For more information on the VLIRT system, contact us.