RENO and TAHOE, Nev. (PRWEB) February 12, 2019
Crucial Data Solutions announces the latest version release of Clinical Studio, which includes IWRS to truly unify randomization and trial supply management in the clinical trial management process. Clinical Studio is a web-based enterprise eClinical system that is dedicated to improving data quality, reducing costs, and increasing EDC usage in clinical research.
IWRS, which stands for Interactive Web Response System, is a technology tool that allows research teams to facilitate patient randomization and manage drug supply. Traditionally, those capabilities have been done on disparate platforms, separate from the study data itself. Randomization and product tracking are now tied together and part of one streamlined system in Clinical Studio.
There are a handful of benefits of having IWRS and electronic data capture (EDC) accessible within one system. Because IWRS is already integrated into Clinical Studio, there is no programming needed and no added legwork to transfer data to an EDC platform. This also means sites no longer need to be logged into multiple software platforms. Instead, research teams are able to accomplish trial management tasks within Clinical Studio in an automated way.
Clinical Studio allows for double-blinded, multi-stratified or central randomization. It can return separate IDs for randomized patients, as well as perform multi-layered randomization. One of the value-adds to having this function tied to the EDC itself, aside from ideal accessibility and speed, is that research teams can control the rules of data entry based on the subject’s randomization allocation. For example, if specific questions, forms, or entire visits are not applicable to subjects allocated to a control group, the system will enforce that data control.
Trial supply management was greatly enhanced in the latest version release of Clinical Studio. Study designers can create their own customized product workflow or lifecycle. The system can optionally generate and print barcodes on label sheets to make tracking as efficient as possible. In TrialKit, Clinical Studio’s mobile companion, use the camera on a smartphone or tablet to scan barcodes through the workflow, eliminating errors, manual work, and dealing with multiple items at once. Each step of the supply management process is audited and adheres to 21 CFR Part 11. The system will also generate automated reports related to inventory.
What does it look like when randomization and product tracking are used together? First, each site contains a number of products in inventory. Multiple arms allow for products to be of different doses or placebo. When a study participant is randomized, the system tells the site coordinator which product to pull from inventory and use on the participant. The site coordinator can even scan that product to verify they have pulled the correct item. For blinded randomizations, each product is completely blinded so the site has no idea which dosage they are using, eliminating site bias. As the inventory gets low (floor) at a particular site, Clinical Studio sends reorder notifications to bring the inventory up to the predefined ceiling.
It is important to note that Clinical Studio supports randomization and product tracking whether they are used in unison or not. Leverage these features separately or together in the system. And for those who work more efficiently on their phone or tablet than their desktop, TrialKit shares all of the same capabilities as Clinical Studio’s mobile app counterpart. To learn more about Clinical Studio’s IWRS functionality, please contact us at firstname.lastname@example.org.
About Crucial Data Solutions, Inc.
Crucial Data Solutions, Inc. is a forward-thinking company dedicated to developing innovative technologies that reduce the cost of medical research by equipping clinical professionals with the tools they need to advance treatments that enable patients with life-altering conditions to lead better lives. We believe clinical research should be a true partnership between ourselves, research professionals, caregivers, and patients worldwide.