Karen Travers is head of clinical development systems at Vertex Pharmaceuticals. She's been using the life science offering of Tourtellotte Solutions. The Boston-based Tourtellotte makes drug supply management software and recently updated its flagship product, tcVisualize, to version 2.0.

In some cases, estimating drug supplies in clinical trials is a seat-of-the-pants affair. It involves middle-school math: multiply the number of sites by the number of patients, add in a fudge factor, and there's your estimate. But especially for biotechs, just manufacturing the supplies is a significant budget item. "As drugs across the board get more complicated to make, there is more pressure to make that more efficient," Travers says.

Vertex wanted something rigorous. Travers is especially impressed with the simulation aspects of the Tourtellotte tool. We previously wrote about that program some time ago. The key idea is that it drops your clinical trial supply issue onto an animated map, allowing multi-center distribution networks to be represented on a computer screen. Central patient randomization? Site-based patient randomization? tcVisualize can handle it. Depots in different countries, investigative sites, supply lines--each can be added to the simulation with a click.

Travers calls tcVisualize "head and shoulders above anything we looked at." The biotech company has used tcVisualize in one trial, and hopes to expand it throughout its portfolio of projects. "You have visibility into the impact of your decisions," she says. "It's absolutely excellent."

As the program simulates supplies, she says, there is an ability to fine-tune assumptions. "It allows you to adjust them at a granular level," she says. "You should understand if you add two countries, what that might look like."

In a chat with Ed Tourtellotte, the company's CEO, it's clear the company's core technology is also used in a different product for the consumer retail industry; stores like Target and Staples are customers.

In pharma, Tourtellotte says, one of the biggest changes is that the program can now display actual data from a trial. "You can analyze what has happened so far and forecast that forward," Tourtellotte says. "Given where I am today, where am I going to end up? It can be used for reporting and dashboarding. You can say, 'Where's my trial?'"

In some cases, Tourtellotte says, the software is used to help senior management understand that a particular supply plan may be inadequate. "They may have unrealistic expectations of what is possible," he says. "You can prove that a plan doesn't work. It's a tool for people to first understand the implications of their trial design but also to explain the implications to others."

One common data input, he reports, is from interactive voice response (IVR) systems. Based on a customer's user privileges, he or she can access status reports on the relevant trials in blinded or unblinded fashion.

The system can also incorporate a variety of expiration dates and lot numbers. Such details can loom large if a trial is unfolding with multiple languages, labels, and package inserts, Tourtellotte says. Biotechnology products are especially perishable, of course, but small molecules that take eight months to manufacture can also upend supply chains.

"There is lot more focus on reducing overage and reducing waste," he notes. The issue is not whether there is some necessary amount of waste to allow for some margin of error in the projections; the software allows that amount to be estimated more accurately.

In the future, the company's tool will allow users to run the same Monte Carlo simulation a few thousand times for even higher levels of confidence in what the numbers are projecting. Also on the drawing boards: the ability to accommodate trials with variable dosing regimens (where the total quantity of medication to be received by each patient fluctuates dramatically) and pooled studies, in which different trials studying the same compound share the same reservoir of product. "It's a really good buffer," Tourtellotte says. "If you've over-packaged in one trial, you can consume it in another."

Business is good, he says, with headcount down slightly (to 45 people) despite two high-level appointments. Earlier this month, Tourtellotte selected David Diamond as his new chief operations officer; Diamond spent years in the Pentagon and at several top Massachusetts technology concerns. Former Boston TV newscaster Eileen Prose, meanwhile, was brought aboard as director of sales. She most recently worked at the Allen Roche Group, where, as senior account director/producer, she managed integrated media programs for many Fortune 500 companies.

All too often, bright medical luminaries have software forced upon them. Clinical sites may be finding all the patients, thinking big thoughts, but their tools are chosen for them. With each new trial, such sites receive another laptop, another program to learn.

So one wonders: what do penny-pinching academics and government scientists choose on their own dime?

One answer: OpenClinica from Akaza Research, out of Cambridge, Mass. The University of Connecticut just selected the package. Here's a complete list of features of the Akaza platform, which has been downloaded 3,000 times. There are 800 registered users.

It's all web-based, and easy to get data in and out of OpenClinica. The program conforms to the CDISC Operational Data Model standard. There is a wealth of both scientific and IT features. OpenClinica has special functionality for managing patient visit schedules, protocol compliance, and trial design. It combines elementary features of many commercial products.

One wrinkle is that it is a rudimentary clinical data and trial management system: OpenClinica can be used to manage data, sites, and trials. Users can create and manage case report forms. To quote the company's website: "It facilitates protocol configuration, design of case report forms, electronic data capture (EDC), and study/data management. OpenClinica supports HIPAA and 21 CFR Part 11 guidelines and is designed as a strictly standards-based, extensible, and modular platform." At many universities, the IT departments can get the free OpenClinica software up and running. The software really is available at no charge. If users need additional configuration or trial setup help, Akaza's 12 employees will provide services on top of the software.

"We're doing a lot of work in the academic space," says Cal Collins, Akaza Research's CEO. "It's nice to see momentum for that starting to accelerate." He's young but previously co-founded e-guana.net, currently known as Isovera, and before that studied database systems and geographic information systems (GIS) at Harvard University, from which he graduated magna cum laude.

A new version of the software is being released on November 9. It will have enhanced EDC functionality, with better tools for managing data and tracking subjects, not to mention additional support for other data formats like SAS transport files.

OpenClinica is designed for more academic collaboration, he says, at a price that doesn't break a professor's budget. "We have been in situations where our costs were a third or a quarter of competing quotes," Collins says. "We saw a need for a platform that had a lower costs of entry and a more fundamental business model that would support interoperability and transparency and community-driven development."

Inside academia and government, Collins says, there is some wariness about the commercial clinical trial technology vendors. "On the high end, there are issues with cost and vendor lock-in--and the inability to customize things or get the solution exactly the way you want it. We really see the industry as in a fragmented situation. It's a complex field. A lot of the fragmented solutions don't talk to each other."

In an age when anything running on Windows is a bit dubious from a security standpoint, Collins says OpenClinica can be less easily infected. "An open source platform has the potential to be more secure," Collins says. "There are more eyeballs looking at the code and looking for holes." The platform runs on the Oracle 10g and Postgre SQL databases, with ports to IBM's DB2 and SQL Server in the works. The community of OpenClinica developers is strong, he reports, and self-sustaining with its own website.

Last month, the annual Clinical Data Interchange Standards Consortium (CDISC) meeting saw president Becky Kush in fine form, with 200 attendees and a new media coordinator in tow.

With 175 organizations as members, the robust and vibrant CDISC is a tribute to Kush's vision for nonproprietary pharmaceutical data standards--and to her uncanny ability to attract both indefatigable generals and savvy ground troops for the fight.

People like Wayne Kubick, a longtime Kush ally and Phase Forward employee, kept the 2006 CDISC meeting rolling along with a more impish, even gleeful, atmosphere than might normally attach itself to a week-long acronym festival showcasing a few zillion screens of XML code. The opportunity to do something for the industry as a whole seems to invigorate and inspire just about everyone associated with CDISC. It's nice to see people talking and working with arch-rivals and competitors in a collegial manner.

One of the ironies of the growth of CDISC is that the largest vendors in the industry are now registered by CDISC. The organization has also just begun certifying vendors, which is an additional level of evaluation that costs between $2,000 and $12,000, to assess adherence to the Operational Data Model (ODM). Not long ago, a few of the same companies publicly doubted whether any customers actually cared about standards. Now they have religion.

Kush says sponsors of clinical trials, large and small, are starting to see the wisdom in standards. "They've seen the value for providing standard formats for FDA," Kush says. "They're starting to see that for a given trial, over half the benefit comes if you start the process up front."

There's a lot going on. The individual CDISC standards are being slowly refined and combined with each other. The FDA spoke at the conference and has more or less announced CDISC standards will eventually become official policy. Work to assimilate CDISC standards with those of hospitals is ongoing. The CDISC work is especially powerful in analyzing drug safety issues: It facilitates analysis across trials and throughout a class of compounds.

"Some companies can go look at their database and find they don't have to do post-marketing studies they thought they would have to do," says Kush. "If you have the data, you can say, 'Oh, we don't have to do a study.' Or they can do better designs."

In short, data standards are, well, increasingly standard. Kush's next goal: to continue the work of contract research organizations that had sought to standardize each element in a case report form. If this highly ambitious effort succeeds, "weight" on a clinical trial form would mean the same thing across the industry. PhRMA is participating, as is NIH, as is the AMIA. Says Kush: "It will help vendors. It will help FDA. It will help sponsors. FDA sees it as a path to higher-quality data."

Even so, Kush concedes that the unique history and landscape of data at each life science customer can complicate the transition from a customized approach to standards. "We are trying to figure out the best way to convey a business case," says Kush. "The savings rate up front on a trial is 80 percent. But if we start extrapolating that into dollars, people say, 'That's not the way it is at my company.' So we are going to give people an Excel spreadsheet so you can plug in your own numbers."