It’s 5PM, Do You Know Where Your Documents Are?

Case Studies, IRT Essentials

One of the much-lamented aspects of a regulated industry like pharmaceuticals is the amount of documentation required for the successful conduct of a clinical trial for new drug development. The old industry adage ‘if it isn’t documented, it didn’t happen’ was with us at the birth of modern FDA trials and it remains just as true today. The move from a predominantly paper-based environment to an electronic environment didn’t change a thing – the lament just moved from one venue to the next!
To complicate matters further, client audits and government inspections make it necessary to be able to lay your hands on a document expeditiously when called upon to do so. Government endorsement of GCPs and document management standards further add a string of ‘must do’s’ to everyone’s SOPs.

IRT – Not An Afterthought

IRT Essentials

Planning the official EDC or clinical database for an upcoming clinical trial is a unilaterally intense initiative. This is not always the case for other, also-important, applications used during a clinical trial – including collateral systems like Interactive Response Technology (IRT/IWR/IVR).

The IRT serves as a remote ‘front end’ for certain key clinical trial activities. Whereas the EDC is the clinical database, the IRT is widely recognized as the tool of choice for randomizing patients and managing drug inventory and subject drug assignments (including shipping and warehouse/depot interactions). The IRT is also first in line for important information about subject compliance with visit schedules. For many projects, IRT data is pushed to EDC systems on a transactional basis, eliminating the need for redundant data entry by busy clinical site users.

Managing Drug Returns with IRT

Case Studies, IRT Essentials

Drug accountability and the problems associated with it remain key issues for clinical trial management as we move into 2018.
Using an IRT (IVR/IWR) system to manage the distribution and assignment of investigational product (IP) is now a well established practice. Most IRTs these days also include some method of managing and documenting the return and destruction of IP consistent with federal guidelines which require Sponsors to account for all of their trial’s unused drug.
But IRTs differ in the functionality they offer with regard to accountability.

A Powerful Approach to Visit Windows

Case Studies, IRT Essentials

Having robust information on study visit windows and scheduled activities that is easily configurable (and reconfigurable as need be) is an important requirement when vetting IRT (IVR/IWR) systems for clinical trials. What kind of information should you look for?
First, there are the basics: scheduled activities, activity windows, and options for window enforcement. Here’s a project example from our VLIRT® system: