With New Version and Lots of Cash, ASP DataTrak Takes Aim at the DBA, the CDMS - and Partners with SAS

Here's a sentence in the news release about a new version of DataTrak's software:

"Clients wishing to switch product suites no longer have to wait until the trial is completed before launching a new project with a different technology solution."

That is aimed, like an arrow, at electronic data capture (EDC) companies that are disappointing their customers.

The background? DataTrak has finished 67 trials since 1993. Another 60 studies in 47 countries are live. The company does EDC in application service provider (ASP) mode and says its technology has been used to support 14 new drug approvals at the FDA and EMEA.

After a chat with Marc Shlaes, chief technology officer and VP of R&D, it's clear DataTrak is attempting to help customers minimize the delays associated with database administrators (DBAs) in the clinical world. In coming up with its new version, DataTrak endeavored to give ordinary clinical types the ability to reconfigure a trial in midstream. Crucially, the company says it can allow that without the involvement of a DBA.

Shlaes notes that the company has always permitted midcourse changes. "All of those things would have to be figured out manually and applied at the database level by database experts. Then the results would be validated with a validated tool." Now that has changed. "We don't believe that any mid-study change will have to be done at the database level again," says Shlaes. Instead, the user interface allows an end-user to tweak what needs to be changed - and the application automatically adjusts the underlying database.

For customers who have been through the process of creating discrete components of a trial once, the time savings with the new version could be huge. Says Shlaes: "We've been able to slash the design time by an order of magnitude."

Under the hood, DataTrak generates for each customer - as it always has - a library of modules for edit checks, case report forms, units of measurement, gender, etc., etc. But the company's new version has native compliance with the Clinical Data Interchange Standards Consortium (CDISC) approach for the Operational Data Model (ODM), Version 1.2.

Shlaes says DataTrak customers are serious about CDISC - even if that means having different flavors of CDISC inside the same company. To ensure forward compatibility during the years each trial may take, DataTrak's new software allows up to five aliases to refer to a single data item. That will allow seamless transitions from one iteration of the CDISC standard to another. "As more and more acceptance of CDISC occurs over a four-year study, you're good to go," Shlaes explains.

He goes on to say that CDISC data schemas have been used within the company for years, with many resulting efficiencies. An example: DataTrak more or less tutored a few customers' central labs in the formatting of lab data. That helped both the sponsor and DataTrak.

Shlaes, clearly, is not on the fence about CDISC. He wants to make sure his stuff supports the standard. "We've been using it in production, and saving ourselves and our sponsors time and money for years. We have achieved major benefits with CDISC."

The company's CEO, Jeffrey Green, notes that he has had record results of late. "We had a very good 2004," Green says. "We just recently raised some additional cash. Things are going well." This does not mean he's complacent. "The market is still moving slower than it should. We should be four or five times the size we are now. We have a lot of staying power to wait for people to see that EDC is inevitable, which I believe it is."

We asked him about funds deployed to develop internal solutions for EDC and other clinical data management tasks. Green has no idea what the industrywide numbers are, he confesses. But his own conversations indicate a subsiding of in-house clinical development: "I think the wave of customers rolling their own has dissipated. There are examples, like Novartis. But that is clearly the minority of situations."

One of the developments that Green highlights is a partnership with SAS. For an extra fee, DataTrak will pipe clinical data directly from its server into SAS Drug Development - and out. This is not brand-new, but it's worth explaining. SAS Drug Development is a large, expensive application that usually resides behind the firewall.

As Green says: "The data will automatically be configured so that a customer, every 24 hours, could log in to their study and have SAS-auditable data." In short, the sponsor would require no clinical data management system (CDMS) to clean, massage or otherwise configure the data prior to analysis in SAS. We can hear a few readers whispering "hallelujah" under their breath.

The service grew out of market research, Green says. "We did focus groups with SAS before launching this. We wanted to hear what people's pain was. We had statisticians and data managers in the room. We were able to quantify the value proposition of what we're saving them."

Outside the mammoth drug companies, Green says, there is an ongoing debate on whether a CDMS is a must-have or an anachronism. Says Green: "The people who are going to recognize the value of this are those who have decided not to invest in a CDMS. Now they will never have to."

This is a refrain heard at many clinical vendors that do not offer a CDMS. It's interesting to contemplate whether the older CDM systems confer a competitive advantage, or could even become a hindrance to the adoption of newer, fresher clinical technologies. Sponsors and end-users with opinions on this are cordially invited to chime in. Let us know if your comments are clandestine and anonymous - or can be attributable to you and your company.

Green says the reason for the shift in thinking on the CDMS front is not due to any inherent issues with those monster applications. It's simply an indication of impatience. Getting the data ready for SAS is just taking more time than those at smaller sponsors are comfortable with. Says Green: "At most of these places, it's taking weeks or months to do." The company's website is here.

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Clinical Trials Congress - February 23-25, Loews Hotel, Philadelphia, PA Leverage Natural Products for Drug Development conference - February 28 - March 1, Philadelphia, PA Pharmatechnology Congress - March 14-16, Loews Hotel, Philadelphia, PA Beyond Genome 2005: The Future or Medicine - June 13-16, Fairmont Hotel, San Francisco, CA Access Human Safety and Risks - May 23-25, Boston, MA E-Clinical Trials and Research Program at Bio-IT World Conference + Expo - May 17-19, Boston, MA Best Practices Awards - Call for Entries - Deadline March 15th   Would you like to see your conference or event listed here? Contact Shari Redan at shari_redan@bio-itworld.com for more information.

TranSenda: Putting Your Process Front and Center At Long Last

If this columnist had a dollar for every time someone used the phrase "process change," we would be living far from the madding crowds. It would be somewhere in the mountains, in a small solar-powered cabin with access to the Internet via satellite. As life turned out, we reside not far from a government-funded NASCAR-driver training track called the Massachusetts Turnpike, a.k.a. I-90.

But TranSenda, in the Seattle area, has renewed my interest in the phrase "process change." Why? Because it recognizes that many companies' technological needs require customized approaches. Not every sponsor wants or needs another clinical application. Rather, they hope their existing technological assets will work together.

"Custom," in certain circles, is a suspect and discredited term. In this context, at TranSenda, it doesn't mean hand-coded, de novo, lengthy, expensive, or difficult to upgrade. Instead TranSenda's process modules contain pre-tested packets of code that plug and play with each other. The company hopes that will allow it to avoid the pitfalls of "custom" approaches that start from scratch.

The TranSenda solution is called Clinical Trial Process Manager, and it does not fit conveniently into any of the categories that readers may be familiar with. Strictly speaking, TranSenda offers neither a standard application, nor consulting services, nor custom data integration. The company provides all three. Solutions - including licenses and professional services - start at $100,000.

Despite the small price tag, these people are thinking big. TranSenda believes it can link traditional clinical trial applications and databases with manufacturing - or with enterprise resource planning (ERP) tools, among others. The latter might be at the customer premises, or at a contract research organization.

CEO Bob Webber explains that the central idea at the company is business process management, or BPM. His is a scalable, quickly deployed, customized approach. "We've targeted the biotechs," Webber notes. "They have a need to get started but don't want to invest in a half-million dollar clinical trial product. They need access to the data throughout the organization."

TranSenda will not try to go head-to-head against major, established clinical technology vendors. Instead, it has based its platform on Microsoft technology, with an eye toward making multifaceted systems that connect existing applications or provide targeted versions of applications.

They can deliver bare-bones tools to do scheduling, electronic data capture, adverse event tracking, clinical data management or clinical trial management. Says Webber: "We can start small and manage their processes and maintain the flexibility to grow later. We're making data from silos available across the organization. It's not just moving data from one system to another. It's making that data widely available."

The company starts with its own version of a Visio-like, drag-and-drop tool to diagram a work flow. That tool immediately creates an XML-based prototype for a prospective client. In a demo, clients who see the on-the-fly XML code are impressed, as that step alone can take a long time with traditional techniques. The company's approach provides under-the-hood functionality to ensure compliance with 21 CFR Part 11.

Jerrett Cangie, an account executive at TranSenda, says that some prospective customers don't know what a clinical trial management system is. Others are painfully aware that they have been paying for 37 features that are never used. "A larger solution doesn't have the option of stripping down the solution and giving customers just what they want - and charging them just for what they need," he says.

The ugly truth behind the proliferation of applications and databases, Cangie notes, is that data errors and duplication may arise. Let's face it. If you're keeping track of patient appointments in a dozen Excel spreadsheets, something may go awry if the cell in the 125th row, in the 85th column accidentally gets erased.

As Cangie envisions the clinical landscape, there is room for a bespoke, multi-functional platform that combines whatever features a company might need. Says Cangie: "We suspect that our BPM solution could provide small- to mid-sized biopharmas a more flexible and cost-effective EDC and/or CDMS platform than many of today's hard-coded industry leaders. We also suspect that our technology could potentially be used to extend the value of existing EDC/CDMS deployments by connecting them with other functional groups and applications to provide broader reporting, auditing and inter-department communication."

The connection of clinical and manufacturing teams is an intriguing proposition and will be interesting to watch. Here's more information on the company.

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Upcoming Industry Events Clinical Trials Congress - February 23 - 25, Loews Hotel, Philadelphia, PA The 2005 Clinical Trials Congress provides attendees with case study examples of clinical process optimization, the latest tools and technologies to increase efficiency and to maximize their clinical ROI.  With the highly-anticipated FDA Critical Path Initiative being released by the end of 2004, CTC is proud to have Dr. Janet Woodcock, the Director of Center for Drug Evaluation and Research at the FDA discuss the details of this Initiative and its effects on clinical trials. CTC provides numerous panel discussions, roundtables, networking receptions and interactive sessions. Visit  www.clinicalevent.com Leverage Natural Products for Drug Development conference - February 28 - March 1, Philadelphia, PA http://www.cbinet.com/events/HB517/index.html  Attend CBI's Leverage Natural Products for Drug Development conference, in Philadelphia, PA to better understand the value of natural products in the drug development process and methods for harnessing the opportunity they present. Special team discount rates are available. For more information or to register, please contact the Center for Business Intelligence toll free by phone at 1-800-817-8601 or via e-mail at cbireg@cbinet.com Pharmatechnology Congress - March 14 -16, Loews Hotel, Philadelphia, PA Pharmaceutical Technology Congress is the best-in-class meeting place for HOW pharma and biotech manages information and implements technology/IT strategy across the value chain for BOTTOM-LINE DRIVEN RESULTS.Presentations include a focus on: industry best practices, comparisons of pharma company Key Performance Indicators, Case Studies on Technology ROI and sessions on Business Process Management within R & D, Clinical Development, Sales and Marketing and Supply Chain. Visit us at www.pharmatechcongress.com Beyond Genome 2005: The Future or Medicine - June 13-16, Fairmont Hotel, San Francisco, CA. This event Features programs on Bioinformatics, RNA Interference, Proteomics, Systems Biologym, and new to 2005 Genomic Variation. We anticipate more than 1,000 scientists and over 40 exhibiting companies. visit www.beyondgenome.com for more information. Access Human Safety and Risks - May 23-24, Boston, MA CBI's Access Human Safety and Risks - Actual Application of Systems-Based Omics Technologies in Reducing Attrition Rates and the Costs of Drug Discovery is designed to help companies to achieve this goal - to innovate and modernize drug safety tools and practices so that compounds may be screened more effectively and quickly in discovery as opposed to down the line when cost and risks are greater.For more information or to register, please contact the Center for Business Intelligence toll free at 1-800-817-8601 or via e-mail at cbireg@cbinet.com, or go to http://www.cbinet.com/events/HB533/index.html  ECLINICAL TRIALS & RESEARCH CONFERENCE PROGRAM - featured at Bio-IT World Conference +Expo, May 17-19, Boston, MA Register by April 1 with Priority Code: B0102 and SAVE! http://www.bio-itworldexpo.com/live/26/events/26BOS05A/conference/CC977977 eClinical Trials & Research, a specialized conference program co-organized by Ken Getz (Tufts Center for Drug Research) and Becky Kush (CDISC) featured atBio-IT World Conference + Expo. Network and learn from a superb pool of experts who will share their experiences in planning, integrating, implementing and managing a variety of e-clinical research solutions. Register Today: http://www.bio-itworldexpo.com/live/26/register Bio-IT World Best Practices Awards - Call for Entries - Deadline March 15 Enter the third annual Best Practices Awards recognizing the innovative use of technology and business strategies to accelerate the drug discovery and R&D process. Submit your entry by January 30th and receive 50% off the entry fee price.  Visit www.bio-itworld.com/bestpractices/ for more information.