Time is money, and never has the cliché been more apt. With biotech pioneers spending an average of 10 years and more than US$1.2bn to bring a new therapeutic to market, in recent years there has been a particular focus on applying technology (particularly Cloud-based tools) to the challenge of running costs and time-efficient trial processes.
So what are the issues that waste time and leak value from the drug development process? In 2010, McKinsey & Company published a report that found mismanagement of the trial master file (TMF) was responsible for slowing down trials by an average of 12 months, costing providers up to $2bn in lost revenue for a blockbuster therapy.
Bearing these staggering figures in mind, it is little surprise that technology that promises to bend both the time and cost curves down is an attractive alternative for a cash-strapped and time-poor industry.
Despite these economics, a recent study of TMF-owners across the pharma, biotech and life sciences industries finds that only 13% of drug developers have adopted purpose-built electronic trial master files (eTMFs). The study, carried out by Veeva Systems, sought to understand the barriers preventing drug developers from taking advantage of eTMF applications that would stream-line many of the inefficient processes that can slow clinical trials. The results highlight some of the common challenges companies face when undergoing major transformations in their business-critical technology, but also illuminate the long-term benefits pharma and biopharma companies stand to gain from making strategic investments in paperless TMF.
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