Achieving comprehensive drug accountability documentation to ensure regulatory compliance is a major issue facing clinical trial sponsors
This is the main finding of a recent poll conducted by ClinPhone, the global leader in clinical technology solutions.
The opinion poll of 250 industry participants was conducted as part of ClinPhone's recent webinar series, 'Drug accountability: full visibility through electronic management'.
The webinar series demonstrated how ClinPhone's newly-launched drug accountability solution can overcome such problems by enabling sponsors to centrally manage the entire drug accountability process.
ClinPhone drug accountability allows clients to demonstrate effective compliance with regulatory requirements by providing a full chain of custody for every medication unit, from dispatch to dispensing to destruction.
The results of ClinPhone's poll highlight that the industry is increasingly focusing on the problem of maintaining accurate drug accountability management within a clinical trial.
During the webinar, 28% of respondents identified that ensuring the provision of appropriate documentation meet regulatory requirements as the biggest issue facing them, and a further 26% pointed to the difficulties in consolidating site records, depot records and destruction certification.
These results identify a need for a better, faster and more efficient way to manage what is currently a very manual and labour-intensive activity.
The findings clearly reinforce the significant benefits that can be gained by using an electronic solution to centrally manage the entire drug accountability process.
Nikki Dowlman, product manager at ClinPhone, comments: "We introduced ClinPhone drug accountability in direct response to the industry need for an innovative electronic solution".
"Drug accountability is an area that has lagged behind related clinical trial activities in migrating to e-solutions, and the results of this poll highlight the need for our product.
"It is vital for every sponsor to be fully aware of the location of every single medication unit from the beginning to the end of a clinical trial.
"By capturing and integrating data from site, monitor, distribution depot and destruction facility, sponsors are able to eliminate inaccuracies between data sources and demonstrate complete tracking of the accountability, reconciliation, returns and destruction process".
ClinPhone drug accountability is a natural and logical extension of ClinPhone's market-leading trial supply management services.
Fully integrated with the company's interactive voice response (IVR) and interactive web response (IWR) services, it facilitates centralised management of the entire clinical supply chain from distribution to destruction.
The real-time access to accurate, quality data allows sponsors to gain complete visibility of the status of every used and unused pack associated with the study.
ClinPhone's new solution helps sponsors minimise paper-based operations and enjoy the benefits of a simplified and streamlined workflow.
