We all do it. It makes no sense. It is ridiculous.

Sending attachments to and fro, hither and yon. “Did you get my attachment?” “Did you read my document?” “Any thoughts?” “Um, which version of that is live?” This is how some people spend their days.

Google has new free software that cuts that way of working to shreds. Google’s new programs are blessedly free of extraneous features. You can create and manage—online—simple spreadsheets and word-processing documents. Those documents can be printed. They look every bit as good as what you create in old-fashioned applications. You can upload Word, RTF and other documents to Google—and then turn around and save documents created in Google on your desktop. You can share those documents with one person or the world. Nor are these dumbed-down tools. There are a surprisingly long list of advanced formulas for spreadsheets and formatting commands for text documents.

Two new online applications from the search engine company should scare many clinical trial vendors—and please users. Could the insanity of the attachment be part of an era that is about to end? We hope so.

Why is this interesting to the clinical trial community? Because sharing and protecting data is very easy with Google. It could not be any easier.

For all the feature bloat in Microsoft products—those little tricks most of us never remember how to do—it takes a lot of work to make any Microsoft application 21 CFR Part 11 compliant. That FDA regulation, of course, governs everything that happens in the pharmaceutical industry. One way to make some Microsoft documents pass regulatory muster is to use a company like Compassoft, formerly known as Wimmer Systems.

Google has a simpler approach.

Out of the box, Google has security that is a) easy to use and b) more internet-based than anything from Apple or Microsoft. What’s more, Google automatically saves every version of your document and records who changed what. That’s right. There’s an audit trail. Online. For free. What’s not to like? Which is why Google Docs & Spreadsheets got us thinking about 21 CFR Part 11.

It is a bit far-fetched to say, today, that academic investigators could run a clinical trial using Google Docs & Spreadsheets. But we’re probably closer to that day than many in the industry realize. Google’s Docs & Spreadsheets, indeed, could be a step up from some kludgy paper-based systems.

Here, pasted from Google, is a list of supported browsers needed to use the Google tools.

  1. E 6.0+ (Windows)
  2. Firefox 1.07, 1.5.0.6+ (Mac & Windows—except for 1.0.8 on Windows and Mac, and 1.5b1 on Mac)
  3. Mozilla 1.7.12+
  4. Netscape 7.2, 8.0

Google Docs & Spreadsheets is not supported, and probably won’t run on*:
  1. IE 5 (Mac) or IE 4 (Windows)
  2. Safari
  3. Netscape 4
  4. Opera”

How secure is the information on Google Docs & Spreadsheets? We have no idea. Perhaps readers will help. Google says that it uses “a secure authentication method,” i.e. a user name and password. The search engine company doesn’t say much more. When you’re Google, you only have to say what you want to say.

The company’s general privacy statement reads: “Google records information such as account activity (e.g., storage usage, number of log-ins, actions taken), data displayed or clicked on (e.g., UI elements, links), and other log information (e.g., browser type, IP address, date and time of access, cookie ID, referrer URL).” Which is not much assurance that you could trace back the source of a problem. But even that is considerably more traceability than Microsoft can offer after a Word document has been flying around the internet (or your company) for a month or three.

All in all, the advent of Google tools threatens Microsoft more than any other company. At a time when Microsoft is preparing a new, much-heralded operating system said to both remedy past security problems and offer exciting new functionality, Google has nimbly leap-frogged ahead. It has jumped past the folks in Redmond and their rivals down in Cupertino with innovative, easy, powerful tools that those in clinical trials should familiarize themselves with.