In an age when large transactions occur online, and total strangers do business virtually, it’s odd how important a paper signature remains. ARX Inc. is trying to change that.

Based in Israel, with offices in the U.S. and Europe, ARX has been around for almost 20 years, trying to help the world manage the snowdrifts of paper that entomb most offices and corporations. They’re not removing paper, as such, but one of the reasons people like paper: You can sign it, spill coffee on it, prove that it passed through your hands. Most of us don’t feel the same way about files on our computers.

Electronic signatures, in many implementations, have been proprietary in nature. A company buys a system. It works. But just try to take a document from that system to another organization.

Then there is the core ARX technology, CoSign, which uses hardware and software to leverage the portable, cross-platform Adobe Acrobat format. Small life science companies, ARX has found, recoil at the price of Adobe Acrobat Professional, which can securely sign documents electronically.

But the Adobe Acrobat Professional package can cost several hundred thousand dollars for an enterprise license. In some cases, smaller pharmas simply license a few key employees. That saves money. But it also creates contorted and inefficient workflows if everything in the company has to go through Dianna over in Regulatory.

ARX, on the other hand, allows every employee to sign documents digitally. The company has a new (free) application, OmniSign, which works with any standard program that accesses a printer. OmniSign is even versatile enough to sign readouts from laboratory instruments.

In addition, ARX has special plug-ins for widely used applications like Microsoft Word and Excel. Best of all, the ARX platform works on old computer hardware—mainframes in the basement of a hospital or academic medical center, perhaps.

ARX installs a box that attaches to your network, and software that runs the box. For those who care about the security terminology, ARX’s CoSign uses public-key infrastructure (PKI) to encrypt documents and signatures. For the rest of you, PKI is an open, highly robust and nonproprietary approach.

Why use anything? Well, ARX cites third-party data that suggest the actual cost of (as the company puts it) “wet signing” your John Hancock with a 29-cent ballpoint pen comes to $18 to $21 per document. Ouch. When one ponders the thousands or hundreds of thousands of pages signed for a single trial, paper signatures may be one of the more glaring extravagances in industry-sponsored research.

The ARX system, by contrast, can pay for itself in a few months. DataLabs and ClinPhone are both using ARX technology to expedite the movement of clinical trial paperwork. “The signature is embedded inside the PDF document and travels with the document to the receiving end,” says Gadi Aharoni, president and CEO of ARX. “The receiving end doesn’t need to install any software to read the signature. You will be able to see the graphical signature, the image of my signature.”

Aharoni adds that European privacy directives, far more strict than anything in the U.S., are becoming the world standard. Global companies, after all, find it easier to learn the toughest rules and adopt them as company policies. “Europe is about half a step ahead of the U.S. in terms of legislation and regulation,” he says. “The number of regulations that specifically require digital signatures is higher than in the U.S.” With governmental and corporate privacy lapses reported in newspapers on a regular basis, he would not be surprised by tighter regulation in North America in the years ahead.

Within the specialized confines of the pharmaceutical industry, ARX says, there is widely enabled functionality that enables entire systems to authenticate users. But it’s another matter to prove who signed a particular case report form (CRF) or a specific 1572 form. “You can’t send your entire database or electronic data capture (EDC) system to a business partner,” says Rodd W. Schlerf, ARX’s life sciences practice manager. CoSign’s ability to allow users to sign partial sections of documents is increasingly attractive, he says, as is letting multiple individuals sign the same document electronically.

Schlerf explains how the ARX system works. “Instead of printing a document to the regular printer, you print it into a CoSign printer. The CoSign printer converts the document into a PDF, and then it applies the signature to the PDF. There are a lot of legacy systems and proprietary or homegrown applications that people want to be able to sign. They print out a document and put a wet signature on it.”

Not using paper probably offers at least three cost savings. The first is the sheer cost of the transporting and handling the document. The second is the delay incurred as pieces (or piles) of paper get lost or forgotten in the course of a trial. The third is the cost of storing paper. In the case of ARX’s e-archiving, the documents’ “signer authenticity is guaranteed, and that accountability, data integrity and non-repudiation of documents and transactions is ensured,” the company website notes.

How much does the ARX approach cost? The price would vary based on the needs of the client. But a one-time charge of $18,000 (plus annual maintenance) might cover a typical installation for 100 users. The most receptive customers, says Schlerf, are those with geographically distributed operations and companies with large numbers of partners and customers.

Email Mark Uehling at markuehling@earthlink.net.