Why being “Study-Team-Centric” Is Important in Clinical Trials

Give Your Clinical Study Team More Power!

In the fast-paced world of clinical trials,  immediate access to information and the ability to adapt are critical.  That’s why Veeva RTSM 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 Veeva RTSM specializes in Randomization and Trial Supply Management, we focus on team-centricity as it can be applied to the world of RTSM.

Below are four quick examples of our “power-to-the teams” philosophy as applied to specific clinical trial 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 of 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 the 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 the control in the hands of the study team, making answers available quickly and at no additional cost. Each data table in our 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.

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 Veeva RTSM system can make it easier for them to get the answers they need when they need them.

For more information on how we can help your next clinical trial, contact us.