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Clinical trials have increased in complexity over the past decade, with sponsors working with an increasing number of sites, countries and service providers. These massive globalized studies place new strains on the organization of essential study documents, collectively known as the trial master file (TMF). In response, vendors have pushed a technological solution: electronic TMF systems.
Vendors pitch eTMFs as a way to easily and securely share clinical study documents with internal and external teams, while also realizing many of the benefits electronic systems have over paper-based processes. Whereas paper files can be lost or destroyed and are only accessible where they are physically located, documents stored in an eTMF are less vulnerable to physical damage and can be viewed from anyplace with access to the web.
Biopharma companies rarely move quickly to adopt electronic clinical trial systems, but survey data suggest that eTMFs are on the rise. In its 2013 TMF survey, the Drug Information Association (DIA) found that 13% of respondents use a fully electronic system, up from 7% in 2010. Even more organizations have adopted a hybrid paper/electronic system. In 2010, just 27% of respondents took this approach. Now it has replaced paper as the most popular model, with 42% of people choosing a hybrid system. In 2012, almost half of the respondents to the DIA survey said eTMFs make internal and regulatory audits less burdensome.
The need to improve document management
Companies are going electronic to simplify research documentation.
The technology is particularly well suited to the modern era, in which sponsors have formed deep collaborations with service providers. William Blair analyst John Kreger has asked biopharma executives about outsourcing for the past three years and found penetration rates to be rising steadily. In 2013, respondents said 59% of late-phase research is outsourced, up from 54% in 2011.
Sharing paper documents in an outsourced system is a headache for sponsors, and the problem is magnified by the globalization of late-phase trials. In the four years ending in 2010, companies utilized study sites in almost twice as many countries as they did in the previous four-year period, according to the Tufts...