Conducting a clinical trial – even a small one – is expensive. Pressure to contain costs is a constant presence in the lives of procurement managers, project managers, and senior personnel in all operational areas of Sponsor-companies and CROs. Accordingly, vendors who serve the pharmaceutical industry also live under intense pricing pressure. A demonstrable ROI – Return on Investment – is therefore a minimum requirement when considering whether a particular service provider is a worthy addition to the project mix.
IRT ... Is It Worth It
What, for example, is the ROI for an Interactive Response Technology (IRT/IVR/IWR) system? As an IRT provider who has successfully deployed global IRT systems for the past decade, Veracity Logic enjoys two types of clients: those for whom the answer to this question of ‘is it worth it?’ is so obvious they can’t imagine how anyone conducts a study without an IRT (as was loudly proclaimed by a number of Sponsors and CROs at a recent industry conference!), and those for whom the vision remains hazy. After all, there are a number of minimal ways to obtain just a simple randomization schedule, for example, short of setting up a complete IRT system for a project. And many project teams are well schooled in juggling drug shipments and subject activities by using spreadsheets and other manual means. Why, then, move to an IRT?
Here are ten (10) answers to that question:
- Savings in FTE and timeline costs compared to the manual management of shipments across multiple sites and countries.
- Ability to utilize complex randomization schedules/processes
- Easier management of diverse site requirements
- Ability to utilize predictive resupply/forecasting to minimize drug waste and maximize shipment efficiency
- Savings in FTE and timeline costs related to all aspects of quality oversight (i.e., a well-known reduction in quality issues compared to manual processes)
- Shortened timelines for managing project specifics, like sequential cohorts, given the common delays in data-entry into the clinical database (EDC)
- Getting risk assessment data soonest, as compared to EDC data
- Proving a demonstrable and defensible increase in security re the handling of study unblinding, along with reducing costs, consequences, and timeline hits associated with accidental unblinding and potential subject/data compromise
- Savings in FTE and costs for managing complex dosing and drug titrations, with an accompanying increase in data confidence
- Ease of managing drug supply expiry and status
Other topics in this month's newsletter:
Share this Post