Medical Translation Insight

eCTD here, eCTD there, eCTD everywhere. With all of the talk about electronic submissions coming and being the best thing since sliced bread, it is easy to overlook two facts:

1. Most pharma companies are still doing paper-based submissions.
2. Electronic submissions will never completely replace paper - there some instances where it simply doesn't make sense to go electronic.

A recent discussion in LinkedIn's Electronic Data Capture group drove this point home.

The consensus seems to be that Phase I studies are likely to stay paper-based. Electronic solutions seem to make sense for studies with more than roughly 200 patients at more than 10 sites. Below that, paper is simpler, faster, and less expensive.

Commentators also posted suggestions for how to evaluate the paper-versus-electronic decision. Here are some of the things to consider:

• Time spent by monitors physically handling paper
• Storage, security, and transport costs
• Need for greater number of support staff
• Cost and time for qualifying EDC vendor
• Cost and time for validating and maintaining EDC system
• Internet access in remote locations

For translation service providers, that means that XML will grow in importance but Word and PDF files aren't going away anytime soon...


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