DataTrak Acquisition of ClickFind: Part One

EDC Vendor Modernizes Product Line

Dr. Green Throws Down Gauntlet To Clinical Technology Industry: How Long Will It Take You To Do What He Can Offer Now?

The DataTrak account executive had been optimistic. Even confident. But then the call came. The news was bad. The contract had gone elsewhere.

And who won the business? DataTrak CEO Jeffrey Green heard the name of the victorious vendor: ClickFind. "I said, 'Who the hell are they?' " Green recalls. Soon he rang up ClickFind and started a conversation. Seven months later, DataTrak bought the once-obscure company for $4 million in cash and $14 million in DataTrak stock.

The ClickFind acquisition, Green says, grew out of DataTrak's assessment of the current urgency in the EDC market. "There is window of opportunity over the next 18 months to be able to offer a complete and unified architecture," Green says.

"Unified" is his mantra. At DataTrak, the innocuous word "integrate" verges on being an epithet, a slur. Green's notion is to help customers choose only the functions they need on an à la carte basis. But everything runs out of one application, one database, one username, one password. Enterprise software is not a new idea. But in pharma, where best-of-breed and point solutions have been the norm, this will be unexpected.

What's more, the build vs. buy analysis to the acquisition of ClickFind was stark. DataTrak could have created its own version of what ClickFind had with an investment of three years and $5 million. But that would have missed wooing potential customers in the meantime.

For Green, the deal became a way to ensure that the company's vision was synchronized with what it could offer customers. "DataTrak is a well-proven point solution," Green says. "If we had to remain true to the vision we saw, with the world wanting a platform with multiple capabilities, we fell short. We had to fix that."

The key concept, for Green, is that DataTrak can now offer the industry a "unified" (he repeats it a lot) solution. The vendor need not claim to integrate a mishmash of technologies designed or acquired over the years. That's what his competitors tend to do.

From a vendor perspective, very few companies are in a position to replicate everything DataTrak has. DataTrak already provided global services on an application service provider (ASP) basis. And ClickFind studied every major niche, every last technology subcategory in clinical trials. Then it built a Web-based equivalent. That effort was audacious and seems to have impressed Green. "We now have the broadest platform in the industry," he says. "We are basically leapfrogging over our competition. We call this a game-changing event."

Green is not known for meekness or a hesitant style of speech. He believes that DataTrak can now offer just about anything except garage door openers. The company's clinical suite provides, on an à la carte basis:

• electronic data capture (EDC)
• group collaboration tools: file management, portals, email
• electronic case report form (eCRF) booklets for enrolled patients
• electrocardiograms (ECG) automatically incorporated into each patient's eCRF book
• clinical data management system (CDMS)
• inventory management
• patient randomization
• medical coding
• XML based interactive voice response system (IVR)
• image management
• laboratory data management
• basic safety data management system
• project management and basic clinical trial management system (CTMS)
• automated EDC startup from Excel spreadsheet
• paper-electronic "hybrid" studies
• custom reports

DataTrak can't do document management or manage payments to investigator sites, but the company is working on that. To be fair, some of the largest clinical trial technology companies can also offer similarly expansive combinations of offerings. Even a smallish company like DataLabs recently acquired Broadpeak and rolled its CTMS solution up with its existing EDC tools.

Still, we're not aware of any vendor that can match DataTrak feature for feature. Large and established companies like ClinPhone, etrials, Oracle Clinical, Medidata and Phase Forward all have elements of what DataTrak possesses, even market-leading pieces in some cases. But in all but Medidata's case, DataTrak competitors require that customers rent or acquire multiple applications. Multiple databases. For some sponsors, that's fine. For others, it's nuts.

Says Green: "A customer doesn't have to buy everything. It's modular. If you want EDC and ECG, you can do that. It is all under one architecture. You pick the functionality you want."

Green's core belief is that some day soon, people will not want to regularly export data from system ABC and import it into system XYZ. Data integration in clinical trials, he says, never really was efficient, even when the vendor had high hopes, or large pharmas threw hundreds of people at the job.

One element of DataTrak's due diligence was anecdotal. An external consultant contacted ClickFind users, and was surprised at the level of enthusiasm. "The references from ClickFind customers were off the scale," says Green.

Green was asked about potential challenges for clinical technology vendors that have either become public or that are rumored to be considering that. Welcome to another level of paperwork, he says. Complying with Sarbanes-Oxley cost DataTrak $600,000. For months, Green arrived at his own headquarters and had no idea if a new face was a DataTrak employee or a consultant working on Sarbanes-Oxley. (Some estimates, he says, put the total U.S. cost of complying with the law at $1.4 trillion.)

Green also notes that private companies that decide to become public will have less latitude in financial statements. Such companies will have more difficulty claiming rapid growth rates in press releases that do not contain hard numbers. "You can't hide your financials any more and say you have 60 percent growth rates," Green says. "Everything will be exposed. The name of the game is leverage and earnings. It's not giving away your technology to buy market share."

In general, Green reports, demand for EDC is as brisk as he's ever seen. For the first time, some customers are not expecting that DataTrak mount a vast, triumphant Broadway musical in response to an ordinary RFP. Instead, they're emailing in orders for repeat business.

We can offer no prediction on how well DataTrak will execute its we-can-do-everything strategy. But if the company can deliver on its vision, DataTrak could leverage the internet, existing facilities and services, and its new ClickFind tools to win some nice contracts. If it works, the Ohio company appears to have the potential to significantly simplify the existing clinical trial technology landscape for all but the very largest sponsors of clinical trials. Many industry giants remain attached to homegrown applications. For all other sponsors of clinical trials, it could be tempting to take a look at what new tricks the familiar DataTrak dog can do now.

: Featured Events :

The 2nd Annual Text Analytics Summit 2006 - JUne 22 - 23, Hilton Back Bay, Boston USA Life Sciences Conference + Expo - April 3 - 5, Boston, MA MIT Summer Session - Registration now open! Stability Programs - June 8 - 9, Princeton, NJ Bio-IT Best Practices Awards - Call for Entries - Deadline April 7 CBI's Drug Development – From Animal Models to Phase I; Pursue Quality Leads by Expediting PK/PD and Efficacy Data Collection -- April 10 - 11, 2006, Philadelphia, PA   Would you like to see your conference or event listed here? Contact Gina Bajenaru at gina_bajenaru@bio-itworld.com for more information.

DataTrak Acquisition of ClickFind: Part Two

Texas Executive Taunts Rivals 

Some entrepreneurs dream of selling their companies, buying a few sports cars and mansions, and settling into a life of golf. Jim-Bob Ward is different.

Ward just sold ClickFind to Cleveland's DataTrak International. The price: $18 million (in cash and DataTrak stock). From the sound of it, Ward simply cannot wait to get up in the morning as VP of e-clinical development at DataTrak, his new employer. That's because he finally gets to go into hand-to-hand combat against the biggest, toughest names in the industry and see who's got the best technology.

Ward candidly admits learning from competitors' public playbooks over the years, avoiding their errors, and relishing the chance to win customers that rivals didn't realize were unhappy. "We're here to play," says Ward. "We're here to stay. We are so glad to be out there, to compete."

The DataTrak deal lets him compete head-to-head against solutions he regards as flawed. So he has no plans to spend his golden years by the pool? "I'm 45 years old," he says with a laugh. "I have no intention of retiring. All I want to do is win."

From the inception of his company in 2000, Ward says, his analysis of clinical trials tools was that the technology environment in clinical trials was needlessly fractured. Point solutions were proliferating like rodents, causing high frustration and cost.

"When we first looked at the clinical marketplace, I'd never seen such a mess in my life," Ward recalls. A unified solution, one that met all the major needs of the clinical trial, was needed. "We knew we could do this. We just didn't know how long the window would be open." The company operated "under the radar," he says, to avoid having some of its ideas about Java, XML, and SQL in clinical trials borrowed prematurely.

When the call came from DataTrak, ClickFind was not on the market. But Ward says he would have been leery of acquirers who could have bought the Bryan, Texas, company and moved it to San Francisco, Philadelphia, Boston, or some other Yankee metropolis where you may need a million bucks if you want a dwelling for little ones, spouses, and pets. Ward says he would never have considered such a move, to protect the cohesion of his 17-person team, all of whom are rooted in Texas.

He also appears to have struck up a warm relationship with Jeff Green, DataTrak's CEO, praising the Cleveland icon's uncensored, straight-ahead candor. "Right or wrong, he was the one out there doing the missionary work," says Ward of Green. "He was trying to build the market for EDC. You have to respect that."

Before ClickFind was acquired, this newsletter covered the company twice, most recently a few months ago. At the time, we worried that we'd fallen in love, just as we reflexively fall in love with any animal, vegetable, or mineral vowing to toss the paper out of clinical trials. There appear to be no big mistakes in our earlier story, which includes a customer reference from a biostatistician.

April Registry Conference: Current Strategy and Best Practices

When the Soviet Union collapsed, it was fascinating to watch ex-KGB officers and grim Politburo members who had never been in front of a TV camera suddenly try to explain policies that had never been open for debate.

The pharmaceutical industry is in the middle of a similar transition. In a few short years, the industry has been forced by medical journal editors and Congressional bullying to offer more data about clinical trials. Long-secret data-lots of it-is available online. Registries are here, most people are used to them, and they're not going away.

But can the industry do registries and databases better?

The Center For Business Intelligence has a meeting on the topic on April 24-25 at the Sheraton National in Arlington, Virginia. We recently chatted with two of the presenters from Hoffman-La Roche. They tell us the Virginia conference will try to help attendees grasp the nuances of both registries (which are primarily for patients) and results databases (which are for physicians, journal editors, and experts writing review articles).

Crucially, the conference has representatives from every major constituency in the clinical trial debate: sponsors, medical journals, patient advocacy groups, and regulatory agencies from the U.S. and abroad. (In the interest of full disclosure, the editor of this newsletter will be moderating a panel at the conference.)

Roche has a few speakers at the meeting, and its perspective is especially interesting. More than two dozen people at the Swiss company put their heads together. They decided that making the information available to the public was paramount.

So the company worked out an arrangement with a publishing and consulting firm, Centerwatch. In addition to what they charge for, Centerwatch has a wealth of free information for the public on its site, and Roche decided that would ensure its data had the highest possible visibility.

In less than a year, after spending a million francs just to tweak its IT systems, Roche has put data from 300 trials on its Centerwatch site, with half a dozen fulltime employees working on just registries and results databases.

Roche's Richard Barr, director of strategic communication, is the first to admit that the needs of registries and databases are in flux. He's looking forward to the conference as an opportunity to look at the raison d'être for these new data reservoirs. The initial reason for a registry, he notes, was to help patients find trials. Then medical journal editors had concerns.

Now there are additional reasons. "It's morphed into this general discussion about transparency," he says. "What kind of transparency are we looking for? What needs to be transparent to whom, when, and how?" It will be impossible to determine success, he suggests, until there is some industry-wide agreement on what the right objective is.

Barr has concerns about many registries-including, it would seem-his own company's. "We risk being more opaque than transparent," he says. "By putting everything out there, we may communicate nothing. We're putting so much data and so many kinds of data out there that the ultimate goal of trying to help patients remains a challenge."

He says there is evidence that ordinary patients find navigating all registries difficult: "People are having a hard time finding the information they want and knowing what to do based on that information." Citing research of ordinary visitors to the ClinicalTrials.gov website, he says many patients have many more questions than that site can answer. "All parties contributing to registries need to ensure that users are at the table when creating, and refining, purportedly user-friendly systems," Barr says. "If we better understand what users are looking for, we have a better chance of providing it." 

Barr says that one lesson of Roche's registry has been that flexibility needs to be built into any design. Politics, from any direction, may require changes on the fly. "The ground rules have changed and changed again," he says. "It is such a mobile situation. The original goal has morphed. The one thing we learned was that you must design a flexible solution, otherwise your solution will be a problem six months later."

A colleague of Barr's, Cheryl Karol, is global director of Roche's department of ethics in clinical research. She candidly concedes that the spate of news reports about clinical trials have left the reputation of the entire industry (not just one company) in tatters. The trust of the public, clearly, is vital for the industry's ability to recruit patients. "We just don't have it," she says. "It's a shame. It's important to have that restored. We need to regain that public trust."

She and most readers are familiar with sizable efforts by industry to comply with the requests of medical journal editors. Karol says that it may be premature to suggest there is a thaw in the relations between the industry and the academic editors. But she expresses the hope that they will understand how extensive, and sincere, the industry's effort to publish details about trials really is.

Karol notes that registries and databases and portals are proliferating. Some of the consequences of that are good: There is more data for patients and physicians to find. But there is the potential for confusion, even bewilderment, at such a profusion of data. One worthy and laudable site, Karol says, is run by the International Federation of Pharmaceutical Manufacturers & Associations.

Karol says the public still has some lessons to learn about the clinical trial process. "Most people don't understand the clinical trial process at all," she says. "It's a little complicated." Ideally, she says, the April meeting can begin to explore ways to persuade non-industry stakeholders that the industry sincerely wants to share its data and engage in dialogue.

E-Clinical Trial Lineup at Life Sciences Expo Register now for our upcoming Life Sciences Conference + Expo (April 3-5, Boston). Go to http://www.lifesciencesexpo.com/live/26/ for more details. The E-Clinical Trials and Research track, which has been co-organized by Becky Kush (CDISC) and Ken Getz (Tufts CSDD), features the following outstanding speakers and topics: * Landen Bain (Topsail Technologies) Single source and an IHE profile for clinical research * Michael Barrett* (Critical Mass Consulting) TBA * Paul Bleicher (Phase Forward) Integrating EHR and EDC: Holy Grail or tilting at windmills?  * Jason Burke (SAS) Is industry ready for an interoperability platform? * John Cline (eTrials) Driving eClinical efficiencies and ROI: CRO and vendor partnerships  * Ramon Dempers (ICM Corp.) Integration to ensure effective drug safety/clinical trials * Don Detmer (AMIA) Beyond trial registration: A global trial bank for clinical trial reporting * John Halamka (Harvard Medical School) The HIT standards panel * David Hardison (SAIC) The emerging role of eClinical research data in healthcare * Ed Helton (SAS) Pharmacovigilance, safety, and clinical intelligence * Alan Hochberg (ProSanos) The future of safety data: SRS in an EMR world * Charles Jaffe (Intel) The global trial bank initiative * Rebecca Kush (CDISC) Progress report on standards: CDISC and HL7 RCRIM * Paul Lammers (Serono) Clinical trials in an electronic era * Gary Lubin (Merck) Capital flows 'upstream' * Charles Mead (Oracle) Semantic interoperability between life sciences and healthcare: Hurdles, realities, and promises * Jean Paty (InVivoData) Electronic patient reported outcomes: Documenting the ROI * Carol Rozwell (Gartner) Creating a clinical trials information management strategy for fun and profit * Uwe Trinks (Sentrx) Clinical trials 2010  * Robbert Van Manen (Lincoln Technologies) Optimizing clinical intelligence in signal detection using hierarchically structured thesauri * Deborah Zarin* (NIH) The International Clinical Trial Registry Platform   (*invited)

: Featured Events :

Upcoming Industry Events The 2nd Annual Text Analytics Summit 2006 - June 22 - 23, Hilton Back Bay, Boston USA Following the massively successful Text Mining Summit 2005, the 2nd Annual Text Analytics Summit 2006 will bring together leading-edge developers and tech-savvy users of text analytics technology. Users and developers will meet in order to discuss:latest developments in text analytics technology;leveraging text analytics enterprise-wide;lucrative emerging applications for text analytics; + much more. Free Ticket Offer We have 2 free tickets to give away to Bio-IT World Subscribers – simply go to www.textanalyticsnews.com/freeticket/bio to enter the prize draw! For further info, visit www.textanalyticsnews.com/bio, call Ravi Virpal on +44 (0) 20 7375 7162 or email ravi@textanalyticsnews.com  Life Sciences Conference + Expo - April 3 - 5, Boston, MA The Life Sciences Conference + Expo features an outstanding program of keynotes, three-day conference tracks, educational workshops, exhibit floor, and award programs and special events.  Speakers will discuss the latest technology developments and research breakthroughs on the complete spectrum of topics involved in drug discovery through market delivery. Learn from actual case studies and panel presentations on how the leading pharma and biotech companies utilize IT and informatics to enhance drug process and speed the time to market. Find out more today at: http://www.lifesciencesexpo.com Stability Programs - June 8 - 9, Princeton, NJ https://www.cbinet.com/show_conference.cfm?confCode=HB653 CBI is pleased to announce the 2006 Stability Programs Summit, which features new, elevated content and a distinct focus on pressing stability regulatory requirements.  This conference convenes leaders from key regulatory agencies and leading case studies to map out the next steps in meeting various stability testing requirements as set by ICH, FDA, ASEAN, WHO, and EMEA.  Attend to learn how to best implement a stability testing program, how to evaluate the tools and technology available and gain insight into the various methods for stability data analysis. Bio-IT World Best Practices - Call for Entries - Deadline: April 7th Bio-IT World is now seeking submissions to its 2006 Best Practices Awards Program. This annual Best Practices Awards Program attracts an elite group of life science professionals: executives, entrepreneurs, cutting-edge innovators and others responsible for developing and implementing innovative solutions for streamlining the drug development and clinical trial process. The winners and entrants will be featured in a Special Report published in Bio-IT World, and invited to attend a gala Awards Announcement reception, held during the annual DIA conference.Find out more at www.bio-itworld.com/bestpractices/2006 MIT PROFESSIONAL INSTITUTE – SUMMER SESSION 2006 The Massachusetts Institute of Technology is currently accepting registrations for 35 intensive, week-long programs designed especially for professionals. Courses taught on campus by MIT faculty from June through August. Earn a certificate and CEUs.  Offerings include biotechnology, chemical engineering, energy, IT, mechanical engineering, nanotechnology, physics, technology policy, system architecture, and other topics of vital interest to today's engineers and scientists.  Visit our website to register and view course descriptions. http://web.mit.edu/mitpep/ads/pi-bioit-may.html CBI's Drug Development – From Animal Models to Phase I; Pursue Quality Leads by Expediting PK/PD and Efficacy Data Collection -- April 10 - 11, 2006, Philadelphia, PA  Expediting drug development is a major concern for the pharmaceutical industry.  Maximizing preclinical and early clinical development not only speeds up the process, but also reduces money wasted on pursuing compounds with little or no potential for approval.  The purpose of this event is to bridge the gap between preclinical and Phase I development.  High level speakers present crucial solutions ranging from developing new humanized transgenic animal models to designing more efficient Phase I trials.  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. Visit: https://www.cbinet.com/show_conference.cfm?confCode=HB637