Veeda Expands Global Capacity with New Oncology CRO

By Stephen DeSantis

Ahmedabad-based CRO Veeda Clinical Research, launched a new division, called Global Oncology CRO, to concentrate on cancer research while leveraging Veeda’s operational capacities in the United States, Europe and India. The oncology subsidiary will be led by its president and chief executive officer, Matt Bowman. The new business will be headquartered in Columbus, Ohio. Kathy Squillace was named to the position of vice president of clinical operations and Dave Colborn was made vice president of data management and information technology.

“Since July 1, 2007 we have been establishing the infrastructure for a global oncology CRO and today we are pleased to announce that both the personnel and technical infrastructure are in place, validated and tested,” said Binoy Gardi, Group Managing Director, Veeda Clinical Research.

The company stated it expects to expand its global capacity with targeted acquisitions in the coming months. Veeda bought a 40-bed phase I facility in Gorlitz, Germany last May. The facility is located in eastern Germany on the border of Poland and the Czech Republic. The unit was established in 1992 and has 15 staff.

Veeda was created in 2005 from the merger of the 18-year-old UK-based CRO, Phase I Clinical Trials Unit and two-year-old Clinsearch, an India-based phase I unit founded by Binoy Gardi and Apurva Shah.

In December 2006, Veeda acquired DICE, a Brussels-based CRO founded in 1989. The firm focused on data management, biostatistics and medical writing and provided Veeda with a European presence outside the United Kingdom.

Bio-Imaging Technologies Acquires Phoenix Data Systems

By Stephen DeSantis

Newton, Pa.-based contract research organization (CRO) Bio-Imaging Technologies has opened up a new book of business with the acquisition of eClinical company Phoenix Data Systems. Bio-Imaging, which specializes in running trials that require medical imaging management, purchased the King of Prussia, Pa.-based company for $24 million, including $17 million in stock and $7 million in cash.

Following the acquisition, Bio-Imaging raised its revenue guidance range from $42 to $45 million to $52 to $55 million. It boosted its earnings guidance from 21 to 23 cents per share to 22 cents to 24 cents per share. The company reported service revenues of $38.2 million last year.

Crosstree Capital Partners acted as financial advisors on the deal.

For the near-term, Bio-Imaging plans to manage the company as a separate entity while it finds ways to leverage its core CRO business.  The company stated it will be looking for sales force, marketing and technology efficiencies. For now, Phoenix Data Systems will remain relatively unchanged. The company will keep its name and continue to be run by its current president, William Claypool, M.D. All 127 of its employees will remain part of the organization. 

“We do see tremendous opportunity, probably in the next year time-frame, to start to look at how we can do things more efficiently and grow more revenues without growing as many people,” said Mark Weinstein, president and chief executive officer at Bio-Imaging stated during a conference call...

eClinical Technology News

Ft. Lauderdale, Fla.-based OmniComm Systems won a contract from Pleiad Devices, a medical device focused contract research organization. OmniComm will become a preferred vendor for Pleiad. The company will use OmniComm’s electronic data capture (EDC) product TrialMaster, initially for a trial studying an eye treatment. "Over the years, our team has had experience with most of the EDC vendors in the marketplace. TrialMaster is one of the best EDC products that we have seen and we look forward to offering our medical device customers this premier service," stated Stephen Brandao, vice president of business development at Pleiad Devices.

UK-based ClinPhone launched a combination EDC and interactive voice response and interactive web response (IVR/IWR) product to help its clients eliminate costs associated with integrating such technologies separately. The EDC component will be DataLabs – the company’s EDC solution obtained through the acquisition of DataLabs in late 2006 – combined with its IVR/IWR solutions for trial management and electronic patient reported outcomes (ePRO) needs. ClinPhone stated the new product guarantees the data that is shared between the two systems will be accurate via the company’s Connect integration platform.

Waltham, Mass.-based CRF has updated its ePRO software product TrialMax to be used on Tablet PC-based eDiaries running Window’s Vista. While the company stated the use of portable devices has created great benefit to its clients, it also sees the advantages of using Tablet PCs for some studies, and with certain patient populations. All of the company’s TrialMax capabilities -- including TrialManager and TrialStudio -- will be supported by all three device types.

Maryland-based clinical technology company Xceleron launched META-ID, a product designed to help clients comply with the FDA guidelines regarding Safety “Testing of Drug Metabolites”. The guidelines were published in February 2008 and seek to encourage more research into a drug’s metabolic differences between preclinical test species and humans. The company stated the product can be integrated into phase I studies already underway and deliver data within two weeks.

Oracle Clinical unveiled a new version of its EDC solution called Oracle Remote Data Capture Onsite 4.5.3. The enhanced product offers new functions geared toward helping investigative site personnel work more efficiently with upgrades such as new spreadsheet displays of multiple case books and edit check capabilities. The company cites industry experts who believe that investigative sites have not traditionally had their voices heard. 

Waltham, Mass.-based Phase Forward released Empirica Trace, an enhanced version of the company’s current adverse event reporting product Clintrace. The new product will bring together Clintrace’s capabilities with the company’s pharmacovigilance and risk management solutions. The product will be managed by Phase Forward’s Lincoln Safety Group. The product is web-based and will provide clients the ability to collect, analyze and report adverse events as well as handle global report distribution, quick data entry and MedDRA query support.

Cambridge, Mass.-based clinical management software provider PharmaPros unveiled its new product Electronic Data Lifecycle Management (eDLM) designed to manage information gathering during clinical research. The company stated its eDLM uses proprietary data integration technology to provide tracking and reporting functionality easily within client’s own systems. The tool allows clients to “orchestrate” this process from various data repositories and from multiple vendors, a capability that is becoming necessary within the industry.

etrials' Reports $2.6M Loss

Morrisville, N.C.-based etrials’ sales were up 17% during its 2007 fourth quarter. The eClinical company reported net service revenue was $4.9 million compared with $4.2 million in 2006. However, it reported a net loss for the fourth quarter of $2.6 million (or $0.24 per diluted share) compared with a net loss of $46,000 (or $0.00 per diluted share) in the fourth quarter of 2006.

The company stated its business costs rose substantially across the board, signifying it is investing heavily to return the firm to profitability. The fourth quarter included a $1.75 million charge it paid for a litigation settlement for a patent infringement case with software developer Datasci.

Net service revenue for the year was up 18%, with $18.3 million reported in 2007 compared with $15.5 million the prior year. etrials reported a loss of $6.2 million (or $0.57 per share)  compared with a $1.8 million loss (or $0.18 per share) in 2006.

The company stated costs were up significantly in all areas. Its sales and marketing costs also rose, partly due to new sales recruitment initiatives. Its R&D spending jumped 21%.also related to personnel costs. All told, $2.8 million was attributed to "increased personnel and related costs."

"Since mid-2007, we have made a number of key strategic senior management hires, made significant personnel upgrades, added a client services practice, and completely reorganized our sales organization to more effectively apply the expertise necessary to match our client needs. Further, we upgraded our IT infrastructure to ensure data performance, capacity, quality and security to position the company for long term growth," said Chip Jennings, president and chief executive officer of etrials.

etrials did, however, state its new project bookings were $7 million compared with $4.9 million in the third quarter of 2006, up 37% compared with the fourth quarter of 2006. The company was awarded 20 new contracts in 2007, including four from new customers.

"Even with our substantial progress, there is still much work to be done and more time required for these initiatives to wholly permeate the organization," added Jennings.

etrials stated it did not expect to benefit substantially from these investments until 2009.

AbCRO Opens Two Offices in Russia

By Sara Gambrill

Sofia, Bulgaria-based, American-owned contract research organization AbCRO opened two offices in Russia.

The St. Petersburg office has three employees and will be in charge of operations, while the Moscow office has one person and runs regulatory affairs. AbCRO has one active oncology clinical trial in Russia now and is bidding on others.

“Russia is the biggest country in our region. We had an existing client base that was interested in working with us if we had operations in Russia, so we decided that it was time that we did,” Dana Leff, chief executive officer of AbCRO, told CWWeekly at the DIA EuroMeeting in Barcelona. 

AbCRO was founded in 1999 and had two employees with an office in Sofia, Bulgaria, and a marketing office in Stamford, Conn. From 2001 to 2006, the company grew strongly, nearly doubling its employees between 2005 and 2006. “Between 2006 and 2007, our revenues more than doubled and our staff increased by about 60%. Our projections for revenue growth this year are about 60%,” said Leff.

AbCRO currently has 170 employees. AbCRO also has offices in Bucharest and Cluj, Romania; Zagreb, Croatia; and Belgrade, Serbia. In addition, the company opened an office in Warsaw, Poland, last year.

The company also has a clinical research associate in Kiev, Ukraine, with plans to open an office there soon. AbCRO has always had a business model that required clinical research associates to be full-time employees, which differentiates the company from some other CROs in the region.

Leff added that the company is planning to conduct feasibility studies in Azerbaijan. That country´s capital city, Baku, has a population of about 4 million and has good infrastructure. Azerbaijan’s average income levels are also a bit higher than those of neighboring countries.

Sara Gambrill, senior editor at CenterWatch and author of The Emerging Markets of Clinical Research.

eClinical Technology News

• Cleveland, Ohio-based Datatrak inked an enterprise agreement for at least $800,000, depending on the extent of services required by the client. The agreement is a three-year subscription license with an unnamed pharmaceutical company in Europe. The model is a contracting mechanism for the company’s platform is a separate option to its “trial by trial” model. Datatrak stated its typical “revenue composition” has been 25% for the technology element of an eClinical implementation and 75% for services. “We believe that we will always have the trial-by-trial business model, because this is more appropriate for clients with smaller pipelines. However, for clients with more predictable and larger pipelines, this model provides very predictable research and development costs and eliminates wasted time involved with negotiation and contracting under the trial-by-trial mode,” stated Jeffery Green, Pharm.D., chief executive officer of Datatrak.

• Seattle, Wash.-based Advanced Clinical Software (ACS) has launched a new version of its clinical trial management software (CTMS) product StudyManager, called StudyManager Sponsor Edition. The product is gear towards smaller sponsors, which may not have internal CTMS platforms. The new edition provides data collection, study management and real-time site/monitor interaction. “I root for the underdog,” said Bruce Schatzman, ACS’s founder and chief executive officer. “Most middle-tier research sponsors we’re addressing with our new product have been dwarfed for years by Big Pharma, which has the resources to purchase high-priced CTMS and electronic data capture (EDC) programs,” he said.

• Research Triangle Park, N.C.-based contract research organization (CRO) StatWorks has selected Akaza Research’s Open Clinica Enterprise for its EDC needs. Open Clinica is an open source, web-based, EDC software system that can be integrated into any existing infrastructure with internal client coding.

• India-based CRO SIRO Clinpharm (SIRO) is implementing a new IT framework using Oracle’s Life Sciences Applications and will use Sun Microsystems’ (Sun) hardware platform. This IT infrastructure will be implemented by DBMS Consulting, an Oracle partner network company.

• Waltham, Mass.-based Phase Forward will be moving to a 165,000 square-foot headquarters housed in a new state-of-the-art, green certified business center. The office is approximately five miles from the eClinical company’s current headquarters at 880 Winter St. The building has been certified by the U.S. Green Building Council (USGBC). A “Green” certification requires specific standards to be met in sustainability, water efficiency, energy, materials and resource, and indoor environmental quality. Phase Forward stated its accelerated growth, and anticipated new growth, created the need for a much larger office space. “Our high-caliber workforce has been key to our strong growth, so remaining in the Waltham area was a critical factor in recruiting and retaining employees and minimizing commute times,” said Bob Weiler, president and chief executive officer of Phase Forward.

Parexel Courts ClinPhone with Takeover Bid

UK-based eClinical company ClinPhone rejected a preliminary takeover offer from Parexel International,  a contract research organization (CRO) based in Waltham, Mass.

Although financial details were not disclosed, ClinPhone said it considered the offer too low.

“The board believes the indicated value materially undervalues the company and its prospects and the board therefore rejected this approach,” ClinPhone said in a statement.

Shares of the eClinical company’s stock, listed on the London Stock Exchange, shot up 16% to $1.93 immediately on the news. Parexel’s shares closed up 3.7% on Feb. 19 at $57.88.

In a statement, Parexel confirmed that it had made the initial offer for all of the shares issued by ClinPhone to be paid in cash. With its initial offer rejected, the company must now decide its next move. 

“Parexel is currently evaluating its options in relation to ClinPhone. A further announcement will be made in due course. However, there can be no certainty that an offer for ClinPhone will be forthcoming,” Parexel's statement said.

ClinPhone has about 730 employees. The company is valued at about $127 million. Parexel had 2007 revenues of more than $900 million.

In an interview with Reuter’s John Bowker, ClinPhone chief executive Steve Kent stated: "We are extremely confident about it (rejecting the bid),” adding that the firm had not consulted shareholders about the approach. We have very substantial plans (for growth). We have a clear business plan," he said. According to Kent, ClinPhone’s directors have not yet consulted with shareholders regarding the offer.

In September 2007, UK-based clinical trials technology company ClinPhone was forced to reduce its estimated 2007 revenue by roughly $20 million and its earnings by $1.98 million. The company blamed the drop in estimated financials to an increase in sales of its electronic data capture (EDC ) software at the expense of licensing the product, telephone outages and a weak U.S. dollar.

ClinPhone said it had an “exceptionally high rate” of contract cancellations during June and July, primarily due to “operational” issues.

Phase Forward Delivers Strong 4Q, 2007

Waltham, Mass.-based eClinical company Phase Forward reported strong fourth quarter and full 2007 annual results on Jan. 31. Revenues for the full year 2007 were $134.3 million, a 26% increase from $106.6 million in the previous year. More than 70%, or $96.9 million, of its total revenue stemmed from its electronic data capture product (EDC) product InForm.

"We believe Phase Forward's proven track record of delivering highly scalable and complex deployments for companies of all sizes serves as a strong motivating factor that influences customers to adopt Phase Forward and has made us a strategic partner of choice for many of our customers. Our strong business momentum and solid industry fundamentals make us optimistic about our outlook heading into 2008," said Bob Weiler, chief executive officer and president of Phase Forward.

Phase Forward’s operating income was $19.7 million for the year, an increase of 50% from 2006. Its full year operating margin of 14.7%. Revenue was up 25% for the fourth quarter of 2007 at $37.8 million compared with $30.2 million during the same period last year 2006. Net income nearly tripled to $15.7 million or 36 cents a share, from $5.48 million.

During the year, Phase Forward acquired the Montpelier, Vt.-based phase I software management company Green Mountain Logic for $5.2 million in cash.

"During 2007, we added over 50 new direct customers. These included clients spanning the global pharmaceutical, biotech, medical devices, CROs and academic sectors and range from the smallest to some of the largest life science companies in the world," said Weiler.

For 2008, the company stated it expects revenues to be between $165 and $169 million.

eClinical Technology News

• New York, N.Y.-based Medidata Solutions electronic data capture (EDC) won an agreement with Boston, Mass.-based CRO Parexel through the Medidata’s non-exclusive service provider model, ASPire to win. Medidata stated the CRO was attracted to Rave’s broad user acceptance, ease of deployment and real-time access to clinical data. Medidata Solutions also landed a contract with Dublin-based Elan Pharmaceuticals for the technology company’s Medidata Rave solution. Medidata stated that much of Elan’s data management operations is outsourced so it needed a product that could be easily adopted by any CRO regardless of past experience with the technology. Elan will use the solution for mid-to-late stage trials in North America.

• Cambridge, Mass.-based Akaza Research launched OpenClinica 2.2, a new version of the company’s open source clinical trial software. The updated version offers enhancements such as improved case report forms (CRFs), international language capability, full study audit reports and improved support for multi-site trials.

• Cleveland, OH-based eClinical company Datatrak has signed a five-year contract with Japanese telecommunications group NTT Data Corp. The enterprise-wide subscription license agreement that calls for NTT Data to standardized its systems on Datatrak platform, allowing NTT Data new Life Science group. The deal is worth $2.4 million with $2.1 million in upfront cash. Any optional services for the platform would be contracted separately. The agreement also gives NTT Data the ability to sublicense the eClinical platform to Japanese contract research organizations (CROs).

• Ft. Lauderdale, Fla-based OmniComm Systems has partnered with the City of Hope, a renowned research and treatment center for life-threatening diseases have entered into a new collaboration. The partnership is an effort to standardize the center’s case report forms and reporting tools to be aligned with the National Cancer Institute (NCI) requirements. City of Hope uses OmniComm’s EDC system TrialMaster.

etrials Becomes Sixth EDC Company to Settle Datasci Patent Dispute

By Stephen DeSantis

Morrisville, N.C., based-etrials has agreed to pay $1.75 million to Maryland-based technology firm Datasci LLC to settle a long running EDC technology patent infringement suit. The settlement includes an upfront licensing fee  for three of Datasci’s eClinical legacy products. By licensing the original technologies, Datasci has agreed to dismiss its claim against etrials, giving up any future royalty rights.

“Obviously we are eager to see more companies in this whole marketplace obtain licenses and start to use this technology. We hope there will be many more,” Marc Kozam, Co-founder of Datasci told CenterWatch.

He stated that the majority of companies from the original lawsuit have either settled with or are close to doing so.

The products in the agreement include ASFlash–offered by etrials in 2002 through 2003–and QSCapture and Webcapture, which aren’t current offerings.

“The settlement limits any future exposure and allows us to focus all of our attention on improving etrials' core operations and expanding our market share within the rapidly growing market for eClinical technologies and services," stated Chip Jennings, etrials’ chief executive officer.

Datasci filed similar lawsuits against eClinical companies Phase Forward, Datatrak, DSG and DataLabs. Phase Forward settled for $8.5 million. In August 2006, DataLabs, which was acquired by ClinPhone in October 2006, settled its suit for an undisclosed amount and a nonexclusive licensing arrangement.

DataLabs cited the primary reason for its settlement agreement was because of the possibility of its customers getting sued, which Datasci was exploring. DataTrak settled their case this year for undisclosed amount. DSG's suit was dismissed in March 2007. The terms of the agreement between Datasci and DSG were confidential.

According to Kozam, Datasci is an ongoing venture that is presently developing new innovations to address some of the challenges in the eClinical Marketplace.

“We don’t have end user products at this point, but there are several areas of development that are occurring," he stated.

In 2002, the U.S. Federal Patent and Trade Mark Office awarded Mark L. Kozam, founder of Maryland-based MLK Software a patent— 6,496,827—for the “methods and apparatus for the centralized collection and validation of geographically distributed clinical study data with verification of input data to the distributed system.” The patent was filed in January 2000 and patent office records show the company began the process of obtaining the patent by filing a Patent Cooperation Treaty (PCT) in May 1998.

Stephen DeSantis is the Senior Associate Editor at Thomson CenterWatch.

eClinical Technology News

Pittsburgh, Pa.-based ePRO company invivodata launched its new version of its EPX management system: EPX ePRO Management System, Version 5.0. The system is web-based and has the capability to manage site performance, patient enrollment and compliance, and data integrity in real-time. The system can also generate user-customized reports and changeable dashboard views. It has an e-mail alert system that signals when items need action taken and boasts the industry’s only electronic data clarification form (EDCF) system to resolve discrepancies in data.

Boulogne, France-based Market Research firm Cegedim Strategic Data acquired Paris-based 3ES, a CRO which specializes in online data management and analysis. 3ES was founded in 1998 and has developed its own eClinical software tool (INES). Its team of 15 employees will integrate into Cegedim’s pharmaco-epidemiological research team in Boulogne.

Paris-based engineering and consulting firm Business and Decisions has launched an eClinical division based in North America at the company’s Wayne, Pa., office. Kathryn Hanson, director of eClinical services and solutions, will lead the division. The company maintains a certified advantage Oracle partnership and will use the Oracle Clinical, remote data capture and thesaurus management system and Siebel clinical trials management system suite of applications. Its services will include technical services, application training, IT compliance and validation, application hosting, and managed services for Oracle’s Life Sciences products.

etrials Aims for Profitability with Rebuilding Plan

By Stephen DeSantis

Morrisville, N.C.-based eClinical company etrials’ third quarter revenue fell and its loss widened amid deep restructuring and organizational changes planned for the next two to three quarters. The company is trying to climb its way to profitability and improve its service delivery issues.

“Last quarter, we began to re-engineer etrials’ operations and transition the company into a more responsive, service-focused organization, building for the future. And we continued that process this quarter,” said Chip Jennings, chief executive officer of etrials.

The company has been undertaking major executive management changes as well. Jennings replaced the company founder John Cline in May, who resigned but still remains on its board of directors. Its former chief operating officer Robert Sammis was replaced with Peter Benton in July. etrials also hired a new vice president of product development, Chuck Piccirillo. The company is also building a new sales force.

Jennings spoke to a number of customers when he joined the company to ascertain what they thought needed to be changed within etrials.

“There was lots of commonality. There was not much disagreement actually. The single biggest issue from a customer perspective was service delivery issues and I don’t think it is any secret that etrials had some problems back in 2006 in regards to that,” said Jennings during the company’s recent earnings conference call.

OmniComm Inked 10 New Contracts

Florida-based electronic data capture (EDC) provider OmniComm Systems inked 10 new contracts during the third quarter of 2007. The additional deals bring the company’s total contracts to 35 for the year.

Among the largest projects were a two-year phase III dermatology study enrolling more than 2,000 subjects at 100 sites and a two-year, anti-infective study with 500 subjects participating at 50 sites. The company cited the integration of Oracle Clinical with its EDC solution, TrialMaster, as being a critical factor in this year’s success.

The company also stated its CRO Preferred Program has brought in 17 CROs partnerships since April.

“CROs are enjoying the benefits of fixed pricing, no hidden costs or fees, a dedicated hosted environment and complete training and sales and marketing support, all distinct advantages of being an OmniComm partner,” said Stephen Johnson, executive vice president of business development.

OmniComm reported $1,076,000 in net sales during the third quarter of 2007 compared with $702,752 during the same period last year. However, it reported a net operating loss of $853,103 during the quarter compared with $759,945 last year.

ClinPhone Inks Deal with Japanese Pharma

eClinical technology company ClinPhone has secured a contract with Bayer Yakuhin, the Japanese affiliate of Bayer. ClinPhone has been named the company’s preferred supplier of randomization and trial supply management services, specifically using ClinPhone’s Interactive Voice Response System (IVRS) for a phase III trial in Japan. ClinPhone opened its Asia Pacific offices in Melbourne Australia in late 2006 and credits the move for helping land this new contract.

ClinPhone's director of business development for Asia Pacific expanded on the importance of having a physical presence in the region.

“This important project demonstrates our commitment to serving our clients in this region. The location of the offices in Melbourne means that ClinPhone is able to provide a more consultative service across the Asia Pacific. The availability of business, technical and operational expertise in Asian business hours will really complement our established 24/7 global service and enable us to focus on the needs of our customers as we continue to strengthen our presence in the region,” he stated.

Quintiles Launches Patient Website iGuard for Drug Safety Service

By Stephen DeSantis

In an unusual move for a contract research organization (CRO), Research Triangle Park, N.C.-based Quintiles has created a new service specifically for consumers of prescription drugs. The free service is called iGuard, a drug risk monitoring and personalized safety alert online site, and it’s a significant step toward patient-directed research.

Using secure methods through iGuard, patients anonymously provide demographic, disease treatment and medical history information to the site, along with contact information. If there is an issue with a consumer drug, such as a change in its prescription label, a side effect warning, or other warnings from the manufacturer or a medical journal, the system sends patients a form to take to their doctors.

And the site offers patients a simpler way to determine a drug’s general risk. The system uses a series of alert levels, such as ‘Low Risk,’ ‘Guarded,’ or ‘High Risk’ so patients know when to seek more information or ask a doctor more questions. iGuard can also poll the patients online for the occurrence of adverse events or for other useful information.

Where does all that patient data go? Quintiles is banking on sponsors seeing the raw information as a valuable post-approval data windfall, and the CRO believes it can sell the data to clients as a unique service offering.

In the U.S., doctors can voluntarily submit safety monitoring data to the Food and Drug Administration (FDA) through a program known as MedWatch. But according to Quintiles, not many of them do. In addition, patients do not often report adverse events to their physicians.

According to the president of the program, Hugo Stephenson, M.D., phase IV research and post-approval safety studies have been costly and time consuming, and the trials often deliver inadequate data...

Medidata Inks Multiple Contracts in August

New York, N.Y.-based eClinical company Medidata Solutions inked a multi-year contract with Copenhagen-based pharmaceutical firm H. Lundbeck to manage more than 10 psychiatric phase II through IV trials. The studies will use Medidata Rave 5.6, set to launch this month. H. Lundbeck stated it chose Medidata’s electronic data capture (EDC) system based on feedback from clinical research associates and site managers.

“More and more, Medidata Rave is serving as the ‘backbone’ of the clinical research process – and we are pleased Lundbeck will benefit from Rave’s ability to easily integrate with other systems, meet the requirements of both large-and-small scale studies and enable them to rapidly conduct multiple studies in their strategic area of research,” said Tarek Sherif, chief executive officer of Medidata Solutions.

Recently, Boston-based electronic patient reported outcomes provider PHT announced it has integrated its LogPad ePRO system with Medidata Rave’s EDC technology. The companies have landed a deal with Sucampo Pharmaceuticals to manage its pediatric studies for the treatment of gastrointestinal disorders.The trial will enroll 120 patients throughout the U.S.

"By integrating multiple data streams, sponsors are able to take advantage of real efficiencies gained by using reliable electronic systems," said Phil Lee, president and chief executive officer of PHT.

Datatrak Revenue Down 37% in Q2

By Steve Zisson

Datatrak, an electronic data capture company, reported its second quarter revenue slumped 37% to $3.07 million and a net loss of $2.97 million or $0.22 per share on a basic and diluted basis. These results compared with revenue of $4.83 million and a net loss of $702,000, or $0.06 per share basic and diluted basis, in the second quarter of 2006. Datatrak laid off 17 employees in the second quarter, recording severance charges totaling $337,000.

The employee reductions in June are expected to decrease annual direct costs by approximately $515,000 and annual expenses by approximately $875,000, for a total cost reduction of approximately $1.4 million per year.

“During the second quarter, we instituted monumental changes at Datatrak,” stated Jeffrey Green, president and chief executive officer of Datatrak. “These changes have not only been related to cost cutting, but also relate to the current reorganization of our entire sales and marketing strategy that clearly was not producing the growth we believe possible with our product offerings. Though it may sound like a contradiction to some, while cost cutting in some areas, we are investing heavily in sales and marketing.”

Innovex Signs Agreement With ForceLogix For Sales Coaching Software

By Steve Zisson

Innovex, the Quintiles unit that provides commercialization services to the pharmaceutical, biotechnology and medical device industries, signed an agreement with software company ForceLogix to provide on-demand global access to Innsight, Innovex's custom-designed sales coaching tool.

When using ForceLogix's "SalesForceOptimizer" application, Innovex managers on six continents will be able to securely and rapidly share information to better coach their field teams.

"ForceLogix's technology allows us to deliver a multilingual coaching process that can be easily and rapidly configured and deployed globally," said Jim Kendall, senior director of Innovex Business Solutions. "This promotes the consistent execution of our coaching and enhances our ability to capture, evaluate and rank sales representative performance.”

Patrick Stakenas, president and chief executive officer of ForceLogix, added, ‘Our on-demand delivery model allows ForceLogix to quickly provide value to companies such as Innovex without the time, expense and added risks of having to buy hardware, software and implementation services.”

John Cline Resigns from etrials

By Stephen DeSantis

Morrisville, N.C.-based eClinical company etrials  reported that John Cline, founder and long time chief executive officer of the company, has resigned his post effective immediately in order to pursue other "entrepreneurial endeavors." He will, however, remain a member of the board of directors.

In 1999, Cline began the electronic paper diaries company Expidata, which was soon acquired by etrials (then PharmaCentric). The company -- along with most other eClinical companies in the space -- struggled through the early days of the electronic data capture marketplace.

As a thought leader in the clinical trials industry, Cline championed the value of paperless trials and helped usher in the modern EDC landscape we see today. In February 2006, etrials merged with CEA Acquisition Corp., a specified purpose acquisition company, changed its name to etrials Worldwide and began trading on the Nasdaq National Market. The merger gave the company a total of $20.5 million in cash.

"I am extremely proud and honored to have led our great employees from a small North Carolina start-up software firm to a top-tier, publicly-held global eClinical solutions company. As I move on to other entrepreneurial endeavors, I remain committed to etrials and support this change in management as a step forward in building a leading eClinical software solutions company," said Cline.

Last week ,etrials reported first quarter net services revenue jumped 51% to $4.1 million, compared with the same quarter a year ago. The company reported a loss of $0.9 million. In the first quarter of 2006, etrials reported a similar loss of $1 million. The company reported its gross margins improved to 47% compared with 40% the previous year.

It also reported a backlog of business of $19.8 million compared with $17.7 million at the end of 2006 and $24.8 million at the end of the first quarter of 2006. etrials reiterated that it expects new project bookings in 2007 will be up 40% to 50% over last year to $25 to $28 million.

“Our balance sheet remains strong, and we are well positioned to capitalize on the accelerating move towards electronic clinical software and services. We continue to believe 2007 will be a year of significant growth in new project bookings for etrials,” said Cline.

etrials has named Eugene "Chip" Jennings as the company's new president and CEO. Just prior to this position, Jennings was the senior corporate vice president of SHPS, a private healthcare management tools and resources company based in Kentucky.

Stephen DeSantis is the Senior Associate Editor at Thomson CenterWatch.

DSG Settles Patent Infringement Suit

Posted by: Stephen DeSantis

Pennsylvania-based Document Solutions Group (DSG) has settled a longstanding, patent infringement suit filed by St. Paul, Minn.-based technology company Datasci. Financial terms were not released.

"We are very pleased that this lawsuit is dismissed, and our current customer base and prospects will be excited to know that this lawsuit is behind us so we can put all our energies toward our customers and products in the life sciences industry,"stated DSG's chief executive officer, Tony Varano.

Datasci filed similar lawsuits against eClinical companies Phase Forward, Datatrak, etrials and DataLabs. Phase Forward settled for $8.5 million in the suit Datasci filed against the company in June 2004. In August 2006, DataLabs, which was acquired by ClinPhone in October 2006, settled its suit for an undisclosed amount and a nonexclusive licensing arrangement.

DataLabs cited the primary reason for its settlement agreement was because of the possibility of its customers getting sued, which Datasci was exploring at the time. DataTrak and etrials have not announced any settlements.

In 2002,the U.S. Federal Patent and Trade Mark Office awarded Mark L. Kozam, founder of Olney, Md.-based MLK Software a patent—6,496,827—for the:

“Methods and apparatus for the centralized collection and validation of geographically distributed clinical study data with verification of input data to the distributed system.”

The patent was filed in January 2000 and patent office records show the company began the process of obtaining the patent by filing a Patent Cooperation Treaty (PCT) in May 1998.

Stephen DeSantis is the Senior Associate Editor at Thomson CenterWatch.

Phase Forward Sees 22% Jump in Revenues

Posted by: Stephen DeSantis

Waltham, Mass.-based eClinical company Phase Forward reported a 22% jump in revenues to $106.6 million in 2006, compared with the previous year’s $87.1 million. In the fourth quarter of 2006, the company posted revenues of $30.2 million, a 28% increase compared with the fourth quarter of 2005.

Income from operations was $4.1 million, representing an increase of 67% from the prior year period and an operating margin of 13.6%. Income from operations was $13.2 million in 2006, representing an increase of 46% from 2005 and a full year operating margin of 12.4%. Net income was $16.2 million, or $0.45 per diluted share, for the full year compared with $12.7 million, or $0.36 per diluted share in 2005. Phase Forward’s share price jumped 7% to $14.49 on Feb. 1.

The company also won a contract with the Dublin-based CRO ICON. The agreement will be under Phase Forward’s CRO Advantage Program. ICON secured four studies in the fourth quarter that will use Phase Forward’s EDC solution, InForm. Phase Forward stated it added 38 new clients in 2006, including CardioFocus, Altana Pharma AG (now part of Nycomed)  Teijin Pharma and Orexigen.

“The fourth quarter was a strong finish to an excellent year for Phase Forward. During 2006, we accomplished key objectives such as winning numerous major purchase decisions, expanding and diversifying our customer base, and enhancing our market leadership position,” said Bob Weiler, chief executive officer for the firm.

Stephen DeSantis, Senior Associate Editor, Thomson CenterWatch.

Medidata Solutions Launches Rave 5.6

Posted by: Stephen DeSantis

Medidata Solutions has launched its newest version of its EDC technology platform Rave 5.6. The new version incorporates clinical trial management (CTM) functionality into its existing EDC product solution, allowing for one integrated clinical data management system.

The enhanced platform can maintain a global library of previously conducted studies to increase the speed of new study design. It can store images or documents as part of a case report form and can generate data clarification forms for sponsors using its double data entry capabilities.

The CTM functionality allows study designs to be edited and stored offline, and communicated internally within a sponsor. The new version also adds additional multilingual capabilities and a new module for local laboratory referencing.

Stephen DeSantis, Senior Associate Editor, Thomson CenterWatch.

Datatrak Forms Enterprise Relationship With GP-Pharm

Posted by: Stephen DeSantis

Cleveland, Ohio-based eClinical company Datatrak has formed an enterprise relationship with GP-Pharm, a Barcelona,Spain-based pharmaceutical company focusing on the development of hormonal and cytotoxic drugs. GP-Pharm is a part of the Lipotec Group, a Spanish-owned biochemical manufacturer and supplier of pharmaceutical, cosmetic and food ingredients. Initially, the contract calls for the company to use Datatrak’s EDC Version 4.0 product for a block of five clinical trials enrolling 730 patients and 145 sites. The trials are expected to be conducted in the next 14 months.

“The ordering of blocks of clinical trials under an enterprise business model structure represents another example of the stepwise progression of this market away from the inefficiencies and higher costs of the trial-by-trial behavior that had previously been the only means of contracting for electronic clinical trials,” said Jeffrey Green, president and chief executive officer at Datatrak.

Stephen DeSantis, Senior Associate Editor, Thomson CenterWatch.

AstraZeneca to Use Medidata’s eClinical Solutions for All Clinical Trials

Posted by: Stephen DeSantis

The New York, N.Y.-based eClinical company Medidata Solutions has been awarded a major contract from AstraZeneca to provide the company with its Medidata Rave electronic data capture (EDC), replacing AstraZeneca’s present in-house system.

AstraZeneca initially will incorporate Medi-data’s platform on 50 to 55 phase II through IV global studies; however, its ultimate goal is to use Rave on all studies within the next several years.

“I think we are seeing a trend, where companies who had internal systems, like AstraZeneca, are making decisions to go with a product that is off the shelf. The other side of the equation for a company such as AstraZeneca, is what is the overhead of trying to maintain an internally developed product,” Ed Ikeguchi, co-founder and chief medical officer at Medidata told CWWeekly. You can read CenterWatch complete in depth coverage of the deal in the December 4th issue of CWWeekly.

You can read the company press release here.

Stephen DeSantis, Senior Associate Editor, Thomson CenterWatch.

eClinical Market Has Strong Year

Posted by: Stephen DeSantis

In its third quarter, Morrisville, N.C.-based eClinical service provider etrials reported 40% growth in services revenue to $4.4 million.Net revenues during the same period in 2005 were $3.2 million. The company reported operating income of $178,331 compared with an operating loss of $148,618 in 2005 during the same period. etrials went public in 2005 in a reverse merger.

Major players in the eClinical market have seen high revenue growth in 2006, primarily due to an increase in EDC adoption and a less fragmented industry. Medidata Solutions reported the company’s 22nd quarter of consecutive growth. Medidata had a 189% increase in year-over-year revenue in the second quarter of 2006, and a 171% increase in year-over-year revenue for the first half.

United Kingdom-based ClinPhone released interim financial results for its six months ending Aug. 31. ClinPhone reported its revenue increased 32% to £20.7 million ($39.5 million) compared with £15.6 ($29.7 million) during the same period of 2005.One notable exception was eResearch Technology, which reported lower than expected earnings in its third quarter. The company’s share price dropped 22% to $6.04 on Nov. 9.

Stephen DeSantis, Senior Associate Editor, Thomson CenterWatch.

Phase Forward reports 26% increase in third quarter revenue

Posted by: Stephen DeSantis

Waltham, Mass.-based Phase Forward reported a 26% increase in third quarter 2006 revenues compared with the same period in 2005. The company reported third quarter revenues of $28 million, up from $22.2 million last year. For the fourth quarter of 2006, the company reported it expects revenues to be between $29.2 and $30.0 million. Income from operations was $4 million, showing a margin of 14.2% and an increase of 66% from the prior year period. The company reported expected revenues for the entire 2006 fiscal year to be between $105.6 and $106.4 million. On non-GAAP basis, the company expects EPS between $0.37 and $0.38.

Smaller EMR Companies Could Push Integration

Posted by: Stephen DeSantis

The use of electronic medical records (EMR) technology to enhance the conduct and efficiency of clinical trials has been highly touted of late. The ability to utilize hospital medical records in patient recruitment is seen as a promising solution to costly subject recruitment delays. Companies operating in the EMR space are looking for ways to integrate their systems to work togther with established eClinical infrasture. Aside from a few of the global IT giants such as Siemen AG and Oracle Clinical, GE Healthcare and McKesson, some of the smaller players in EMR may be the ones to watch out for. Being smart, quick and nimble has a big advantage in the IT idustry.

Time To Embrace Paperless Clinical Trials

Posted by: Steve Zisson

When it comes to efficient drug development, pharmaceutical companies have a lot to learn. Recent research we conducted at Thomson CenterWatch suggests, however, that they might just be getting t he message, at least when it comes to clinical trials In a recent survey, we polled users of electronic data capture (EDC) software – the folks on the front line of research who conduct their clinical trials using this software – for their views on the factors most likely to prevent future drug development delays.

Their top answer: EDC software. When we c onducted the same survey in 2003, EDC software came in fourth.That’s not to say that the industry has embraced the technology yet – only about 10% of clinical trials are currently done electronically. But the results of our survey certainly show a readiness to embrace an electronic trials process, unsurprising given the immense pressures on pharma companies from the courts, regulators, investors and the public at large. Paper trials, it seems, must end.Two recent quarterly reports from small EDC companies support the idea that biopharma is getting serious about efficient drug development...