How to Get a 2 Week IRT Rollout: Re-Inventing the URS

IRT Essentials

One of the things we try to do with our weekly hot topics is bring to the forefront the latest excitements, ideas, and controversies surrounding clinical trials and Interactive Response Technology (IRT/IVR/IWR).

Among the most hopeful initiatives touted in recent industry conferences is the goal of implementing a 2 week rollout for an IRT system, from Contract Approval to Release for Client Testing (UAT).

Smoke and mirrors? Pie in the sky?
Or is it actually feasible?

Actionable Intelligence from the IRT for CRAs

IRT Essentials

One of the hottest topics in the clinical trials industry today is the transition to Risk Based Monitoring (RBM) (see Guidance for Industry: Oversight of Clinical Investigations_ A Risk-Based Approach to Monitoring; and ICH E6 R2). RBM includes the addition of a new ‘centralized monitoring’ function which focuses on risk within and across sites and even across projects, data that is then bundled to inform CRA activities.

But the industry is in transition: the vast majority of clinical trials are still not integrated with RBM processes. Project Managers and CRAs must still rely on IRT and EDC platforms to accomplish the kind of ‘pre-RBM’ remote monitoring within a project that mitigates risk and helps determine where site visits are needed and the level/type of SDV activities required.

In the News: An Overview

IRT Essentials

At three recent clinical trial conferences, industry thought-leaders laid out their current prospectus for revolutionary redesigns of traditional clinical trials processes – in many cases (but not all), leveraging technological advances in the interest of new concepts and efficiencies.