Here I sit watching the commercial break after the bottom of the 14th inning of this year’s Major League Baseball All Star game. Some fans have left the yard, many TV viewers are probably asleep right now, and the last thing anyone wants is for the players to tire themselves out (or get injured) playing a semi-meaningless exhibition game. Wait, what does this have to do with eCTD?
Nothing really, but I think that there is a lesson that we can apply to eCTD-related IT projects. Have you had the experience of an IT project taking much longer to complete than planned? I know I have. Now think about all of the IT systems that a company can consider when making the switch to eCTD. A global life sciences company might need:
- A comprehensive eCTD template package.
- An SPL (Structured Product Label) and/or PIM (Product Information Management) building tool.
- A document management system.
- Enterprise implementations of Adobe Acrobat.
- Enterprise implementations of MS Office.
- A paper/report publishing tool.
- An eCTD publishing tool.
- An eCTD viewing tool.
- A variety of plugins and other "small" applications.
Medium and small-sized companies will need at least a subset of these tools.
When implementing complex IT systems, companies considering the switch to eCTD should always be sure to set realistic expectations. How many IT resources will I have available during the implementation process? What is the target date for my first eCTD? Should I build in some wiggle room to let my regulatory team get used to new eCTD-specific business processes? Does the system’s vendor think that my implementation timeline is tight based on their previous experiences?
The answers to these questions (and thousands more) can vary depending on both the nature of the system being implemented and the nature of my organization. Setting realistic expectations for future IT projects will save me the tension of having to sit through unanticipated delays.
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