ClinPhone launches the first drug accountability software
trials that enables central management of drug accountability
across the entire clinical supply chain, from distribution to
destruction.
The UK-based clinical technology organisation (CTO) identified a desperate need among clinical trial professionals to improve the current drug accountability management processes and thus the Drug Accountability Solution was born.
Clinical trial regulations require that all investigational materials are properly accounted for and reconciled from start to finish, however, current manual methods of drug accountability are outdated and extremely laborious.
"In our market, research drug accountability and reconciliation was identified by clinical trial monitors as the greatest burden on the clinical trial process," Dr Nikki Dowlman, product development specialist at ClinPhone said in a recent webcast.
"The pharmaceutical industry is wasting around $156m (€124m) a year by using inefficient, non-electronic-based clinical trial processes," said ClinPhone business development and marketing manager, Patrick Hughes.
ClinPhone Drug Accountability allows sponsors to create and maintain electronic documentation for the whole drug accountability process, capturing and integrating data from site, monitor and distribution depot users.
It takes away the need for an exhaustive paper trail and removes the need to consolidate and reconcile data from numerous sources.
Sponsors can now manage and track each unit of clinical supplies including receipt at distribution depots and investigative sites, dispensing to patients, return of medication packs from patients, return of used medication packs to distribution depots and final destruction of supplies.
"The new software will also help pharmaceutical trial sponsors effectively comply with regulation requirements and demonstrate a full chain of custody for every medication unit from dispatch to dispensation and destruction," said the firm.
In addition, the software is fully integrated with the company's existing interactive voice response (IVR) and interactive web response (IWR) solutions and features electronic dispensing and returns logs, downloadable data for off-line use by study monitors and real-time reporting.
"By integrating and centralising information through technology, sponsors are able to eliminate previous discrepancies and ensure the integrity of the data," said Hughes.
"This is a product we are particularly excited about as it is the first of its kind in the marketplace."
The ClinPhone drug accountability license fee will be between 15 to 25 per cent of the budget for a typical randomisation and trial supply management solution, Dowlman told In-PharmaTechnologist.com.
"The exact price will depend on the exact configuration of the software deployed and variables within each study."
The technology will be showcased for the first time in the US next week at the 42nd Drug Information Association (DIA) Annual Meeting, Pennsylvania Convention Center, Philadelphia.
