Does the digital world have warts? Yes. They’re called PDFs. The venerable Adobe format is a digital scourge. The PDF is not truly searchable. It’s not version controlled. It’s not auditable. PDFs are big, dumb, proliferating images.

There is only one safe, FDA-approved treatment for PDFs: XML. XML also treats paper-based data, to which PDFs are related.

The notion that vast quantities of clinical and regulatory data are destined for embalming in the PDF format has always troubled us. The PDF represents no improvement over paper. The PDF may actually be a step backward. Data belong in databases. Until now, we haven’t known who to unload our PDF scorn on.

PDF Hex

Then we had a chat with Dirk Karsten Beth, founder and president of Mission3. The company is based in Arizona. Like Octagon Research, Liquent and Qumas, Mission3 is offering tools to generate and track electronic common technical documents (eCTDs). Before going out on his own, Beth worked for companies like Documentum, Filenet and Arbortext. The guy knows document management, both in a general enterprise context and in the life sciences.

But as we spoke to him more, we had an increasingly clear idea that Mission3 is bluring the line between a tool for electronic document management—and electronic project management.

10X Growth

We love the-line-is-blurring story. It’s happening with contract research organizations (CROs) and technology firms. It’s going to be harder to tell them apart. Beth’s company, by the way, is experiencing explosive growth, with revenues at Mission3 up tenfold in the past year.

With the right preparation and process change, Mission3 believes it can save customers 10 percent of the process time from post-discovery through market availability. Put another way, that could mean up to six months or a year now wasted in compiling and preparing a variety of regulatory submissions and filings. And Mission3 is cheaper than the big, well-known names in the space. The software is web-based, meaning the IT department doesn’t need to be troubled with installing it.

Documents & Projects

For Beth, documents and projects are like peas in a pod. “We’re looking at binding those two systems together in an open, web services, modern architecture way,” says Beth. “You can create relationships with those two systems so data can flow automatically from one to the other.”

The company offers a suite of tools that manages all the documents and data from post-discovery through post-approval. Its submissions manager is called FastCrossing. Clinical data can be added to the system. Electronic data capture (EDC) systems that are web-services ready will be able to easily integrate with his system, he says. “We’ve built our solutions to be web-services enabled,” Beth says.

The Goal Line

Just as geese fly north in the spring, life science documents are destined to flow toward regulatory agencies. Mission3 supports both the documents themselves and the multidisciplinary teams that create them. “The end game is a submission,” says Beth. “Whatever the workflow is to get there, we can support that so the data doesn’t have to be manually moved.”

Mission3 is tailored to run on top of Oracle, as both companies recently announced. “Our sweet spot is the mid-market,” Beth says. “The Oracle relationship is driving us a bit more in to the big pharma.”

Here’s a quote from the news release: “The partnership with Mission3 strengthens our presence in the Life Sciences industry and gives our customers a great extension of their investment with Oracle,” said Oracle’s Ron Huddleston, senior director, independent software vendors.

Easy Cloning

What’s more, documents can be “cloned” for other regulatory jurisdictions, meaning that key parts of the electronic common technical document (eCTD) or other parts of a dossier can be automatically updated and populated as the underlying data change. “Once the work is done, your submission is ready to be published,” says Beth.

Here’s how the company describes “cloning” in more detail: “Cloning allows life science companies to manage submissions to multiple regions, dosages, or indications with little more effort than managing a single submission.”

Some companies in the industry, he says, are unaware they are out of compliance with the law. Says Beth: “These companies are breaking the law every day. They are emailing documents back and forth every day. If it’s patient data, and you don’t know who’s got the email, that can be breaking the law.”

Security Measures

The Mission3 system, in contrast, has a secure and audited messaging system. You can see a change to a document in real time. And if Roger in Regulatory starts downloading lots of prized company template documents on a Tuesday, and abruptly quits on a Wednesday, you’ll have a nice, printable report to take to your lawyer showing exactly what he did.

There are a number of document-sharing solutions out there. Microsoft has one. Google has one. 37Signals has one. Mission3’s solution, of course, is 21 CFR Part 11 compliant, which none of those companies can say.

Parents & Children

Aside from the legalities, Beth feels customers in pharma need a bit more industrial strength project management help. What does that mean in plain English? One example is that tasks (selecting a new ad agency, perhaps) can have birth dates and end dates, and parent-child relationships, putting them in proper order before or after other tasks (firing an old agency, perhaps).

Beth says that a new category of customer is discovering what the product can do: “We built MissionFire as a tool for sponsors. Since then, we’ve gotten a lot of traction with contract research organizations (CROs). Some of the largest CROs are looking at our solutions because of our project management capabilities.”

Paper Follies

Naturally, there is a high degree of granular security at the broad project-based level or by individual tasks, milestones or documents.

Longer term, Beth would like to see the industry make the transition away from information stored on dead trees. Especially in the context of the eCTD, which is not yet mandatory at the FDA, paper documents are less searchable, less useful than they should be in the age of networked information.

One of the main issues here is a bit embarrassing to talk about. But every company encounters it. Instead of focusing on the content of a document, people fuss over the fonts, the margins, the appearance. It’s a colossal waste of time across the economy.

“People write content and spend 70 percent of the time formatting the document rather than creating the content,” Beth laments. His system, and other similar systems, tease out greater organizational productivity by minimizing a certain amount of pointless massaging of a document’s bold text.

Online Collaboration

Only when using web-based tools, he believes, does genuine global collaboration occur. He mentions a customer with scientists in several locations. “They have 20 scientists who need to create this content in a single instance. That can’t be done by sending documents back and forth. It becomes unwieldy.”

“Paper is still out there,” Beth admits. “We’d like to see the day when it’s all electronic. You can’t search paper. There are so many problems with paper submissions. Customers that are visionary are seriously adopting the eCTD.”

PDF = Provably Dreadful Forever

How does he feel about the PDF format? He concedes it’s a bit ironic that the format is being used to digitize many regulatory documents. PDFs can’t be easily updated en masse. Nor can they be easily indexed. Reviewers at regulatory agencies who wrestle with dispiriting piles of paper must entangle themselves in dispiriting numbers of PDFs instead. Beth is lobbying for an XML alternative to the PDFs that are part of the eCTD standard.

Says Beth: “If it was all XML, which is what we’re proposing, that would add a lot of value to the industry. We’ve lobbied the International Conference on Harmonization (ICH) with a change request. It’s being discussed in Brussels this month. That doesn’t mean that much. But we’re looking for partners in pushing that standard forward.”

Microsoft, Google

Like any evangelist of a new way of doing things, Beth is optimistic that, however slowly, all sizes of customers in the life sciences will slowly migrate to more efficient tools. He readily concedes Microsoft’s dominance, but does not expect it to persist in the life sciences. Google may be another matter, he suggests.

“The stronghold that Microsoft has on document creation will be changing,” he says. “We’re going to see more adoption of more modern tools, more web-based applications, more collaborative solutions.”