Clinical trials industry struggling with drug accountability
of maintaining adequate drug accountability documentation for
regulatory compliance.
This was the main finding of a recent poll of 250 industry participants conducted by ClinPhone, a provider of clinical technology solutions.
Clinical trial regulations require that all investigational materials are properly accounted for and reconciled from start to finish, however, the majority of drug accountability processes currently being carried out by companies are done manually and are extremely laborious.
According to ClinPhone, 28 per cent of its poll respondents identified that ensuring the provision of appropriate documentation to meet regulatory requirements was the biggest issue facing them.
A further 26 per cent 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," said a ClinPhone statement.
"The findings clearly reinforce the significant benefits that can be gained by using an electronic solution to centrally manage the entire drug accountability process."
A number of firms have developed software programmes to allow various components of clinical trials, such as data capture, to be done electronically, although drug accountability is an area that has typically lagged behind.
However, the problem of drug accountability is something that the industry is now increasingly beginning to focus on.
Earlier this year ClinPhone launched what it claimed was the first electronic solution for clinical trials that enables central management of drug accountability across the entire clinical supply chain, from distribution to destruction.
Called, ClinPhone Drug Accountability, it 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.
As a result, it takes away the need for an exhaustive paper trail and removes the need to consolidate and reconcile data from numerous sources. "We introduced ClinPhone drug accountability in direct response to the industry need for an innovative electronic solution," said Dr Nikki Dowlman, product manager at ClinPhone.
When asked by Outsourcing-Pharma what the uptake of the new product has been, Bill Byron, product strategy director said there had been "considerable interest," however refused to disclose the number of companies using the software due to "commercial sensitivity."
