Korio's Compliance-Centric Platform is Changing the Way Sponsors Think About IRT

Korio is shifting the paradigm in how IRT is built and managed through our compliance-centric platform for randomization and trial supply management (RTSM).??At its core, our platform enforces all quality steps, SOPs, and Work Instructions?within?our product, versus the traditional approach of relying on a series of manual steps that are subject to the IRT provider following - and most critically, following correctly.

Why is this important?

IRT providers may have knowledgeable subject matter experts who follow the appropriate SOPs and Work Instructions necessary to achieve a high-quality outcome for any trial they support. The experience that sponsors have with their provider seems to always sit with the team that is assigned to support that client or clinical trial.??

However, there is a risk and a reoccurring theme as IRT providers grow and scale:??A frustrating decrease in quality and customer service?if the IRT provider’s resources assigned to your project do not follow the appropriate SOPs or Work Instructions to successfully build, deploy, and support your IRT – or if the vendor’s internal systems and technology lack the necessary components of an intuitive, easy to use workflow.

Until now.

Korio's compliance-centric IRT platform enables sites, sponsors and Korio employees to setup, manage and support IRT systems with GxP compliant-outcomes, which is a critical step to solving for delivery issues that people have grown accustomed to - but that are a burden?and a blocker to clinical trial progress.

Some of the features & benefits of the Korio platform include:

• The platform and delivery method ensures that all aspects of IRT system delivery and maintenance can meet GxP, FDA guidance, and other industry best practices.
• Anyone using the Korio platform to perform their work will produce outcomes that are predictable, repeatable, and compliant, adhering to industry regulations and best practices that are embedded into our technology.?
• Trials hosted on our platform include a real-time human-readable audit trail accessible by sites and sponsors to support site inspections, regulatory requirements, and site data ownership needs.?
• Customers have real-time ongoing access to their validated system documents including requirements, testing, UAT, and change history via a comprehensive traceability matrix.?
• Changes can be performed in an accurate, efficient, surgical manner with transparent impact assessment and predictable outcomes.??
• Our employees are set up for success – everyone at Korio has access to the best tools to perform their work in an efficient and repeatable manner to provide consistent, predictable experiences for our customers.?
• Korio’s platform and delivery process is architected to enable feature enhancement and innovation to support the most complex trials without deviating from the platform – the delivery of a simple trial or a robust trial design will be the same.??

To learn more about Korio's unique approach to IRT or to schedule a demo, LinkedIn Message CEO, Ryan Keane or leave a note at https://www.korioclinical.com/contact