New Directions for ClinPhone
By Deb Borfitz

ClinPhone built its reputation as a clinical technology organization on the strength of its Web-based software for patient randomization, clinical trial supply management, and electronic patient diaries. It is now beginning to make a name for itself in other clinical trial arenas, most notably electronic data capture (EDC) and clinical trial management software. "The whole philosophy of the company is to make technology easy to use and minimize the pain for sponsors and study personnel," says CEO Steve Kent from his Nottingham, UK, office.

Ease of use was one of the major considerations of clinical research organization (CRO) Kendle International during its recent evaluation of EDC vendors, says Kent. In May, it selected ClinPhone EDC as its preferred solution. A similar agreement has since been signed with Chiltern International, a large Berkshire, UK-based CRO. The Clinical Solutions division of publicly traded InVentiv Health, headquartered in Somerset, NJ, also just penned a "technology and knowledge transfer" deal with ClinPhone.

Both types of arrangements are routine for ClinPhone, says Kent, but the company has seen "a half dozen [such transactions] in the last few months...a record take-up." The deal-making is important on two fronts: It drives revenues and provides a steady stream of customer feedback on product development. "It's the details that matter to customers and we want to get them right."

ClinPhone entered the EDC business with last year's acquisition of DataLabs, Irvine, CA. Among its unique features is the ability to make paper and electronic data entries into the same database. 

It doesn't hurt that ClinPhone is the first "certified partner" of the Clinical Data Interchange Standards Consortium (CDISC), the leading eClinical standards body, says Kent. ClinPhone EDC (formerly DataLabs Clinical) was "built with CDISC in mind" as will be "every core module and the product [ClinPhone Connect] used to connect them. We believe in open standards and the ability to transfer data seamlessly from system to system."

ClinPhone overall had a very good FY2006, which ended in February, says Kent. Revenue grew 27 percent and earnings-per-share were up 41 percent. New offices opened in Australia, San Francisco, and Boston, while existing offices expanded in Princeton and Chicago. ClinPhone was listed on the London Stock Exchange last summer, under the symbol CNP, providing needed capital to build its services and technology base.

Several new products were also launched. Among them was ClinPhone Drug Accountability, a one-of-a-kind software tool that allows site personnel to effortlessly and remotely track experimental compounds from production to patient ingestion or return to central depot for destruction. It is already in routine use by "a number of customers," says Kent.

The company's data exchange system, ClinPhone Connect, also made its debut. It allows study sponsors to integrate clinical data without having to modify applications on connected systems, including EDC, interactive voice response, clinical trial management, and drug supply management. "[Connect] can be thought of as routing software, allowing data to be transferred to different systems...in a way that most fits the needs of the receiving system," says Kent.

The alternative, which is to create interfaces, tend to have "functionalities that overlap and data ends up being misused, duplicated, or put to the wrong use...because of the different business logics built into [disparate systems]," says Kent.

Most recently, a "ready-made" randomization and clinical trial supply management solution was introduced. Called ClinPhone Compact, it is ideal for "simple trials where speed and simplicity are important," says Kent. This less sophisticated version of ClinPhone's industry-leading platform is currently being used on "well over 20 trials."

The company remains the leading worldwide provider of randomization and supply management software, says Kent, serving the top 50 pharmaceutical companies as well as many biotechnology firms and four of the five largest CROs.

ProSanos Launches Safety Signal Detection Tool
By Ann Neuer

CLAERITY is not a misspelling. It is the name of the latest pharmacovigilance product offered by ProSanos Corp., a provider of safety and risk management services. CLAERITY, launched at the DIA Annual Meeting in June, is a Web-based application designed to improve how adverse events, or "AEs" are mined, analyzed, and interpreted. As Prosanos President and CEO Jonathan Morris explains, the product uses the company's core data-mining technology to detect potential drug safety signals. CLAERITY runs on top of the FDA's Adverse Event Reporting System (AERS), a massive database that supports FDA's post-marketing safety surveillance program for all approved drugs and therapeutic biologic products in the U.S.

"On June 19, Alan Hochberg, our vice president of research, presented the first head-to-head study, which showed that CLAERITY detected 45 percent more drug safety signals than a leading competitor," says Morris. "FDA is very interested in the product, and presently, we are undergoing the contracting process with the agency. The big differentiators for our product are higher sensitivity to signals than what's being used today, better performance, an easy-to-use graphical interface, and results in seconds, not minutes or hours."

The AERS database contains millions of records, known as spontaneous reports, submitted by biopharmaceutical companies, healthcare providers, consumers, and lawyers. There are close to two million records, and although anyone can download the information from the FDA website, FDA does not provide tools to analyze or interpret the data. According to Morris, a number of companies offer first-generation tools for data mining, useful mostly for statisticians and data mining experts. CLAERITY, a second-generation application, enables a much wider range of users to access, search, and interpret this vast collection of data.

"Once someone logs on, there are more than a dozen dimensions that someone can use to help determine if there is a safety signal for a particular drug. There is information about the drug such as class effect, age effect, and gender effect," Morris says. The product also detects signals hidden within the background rate of common medical conditions, such as myocardial infarction, stroke, and seizure. Investigations are interactive and yield two-dimensional visual presentations of potential safety signals, unlike first-generation products that typically provide a one-dimensional list or table and work in batch mode.

The visualizations are enabled by PVmaps, a patent-pending data-mining algorithm that underlies CLAERITY as well as the company's safety and risk management services. PVmaps, a .NET Web-hosted application, detects drug/event combinations occurring at higher-than-expected frequencies in clinical data. It maps out answers to pharmacovigilance (PV) questions such as:  What are the significant signals for a drug of interest? Has a safety signal become more significant over time? How does the drug's safety profile compare to another drug indicated for the same condition? 

As Morris sees it, CLAERITY represents the next generation of data mining and safety tools. "The system works as fast as the user thinks, so instead of waiting for results, their time is now spent interpreting and asking more questions." Morris says product acceptance has been strong, and among pharmaceutical companies who perform data mining in drug safety, there is an awareness of the gaps in the existing technology and an acknowledgement that this technology advances the field.

TrueTrials Uses Transparency to Improve Site Selection
By Ann Neuer

The ABC News program Primetime recently reported on a guaranteed way to lose 15 pounds in two months. The story focused on a group of overweight men and women who had never been able to lose weight. They agreed to be photographed in skimpy bathing suits, and were told that if they did not lose 15 pounds within two months, those photographs would be broadcast on national television. To avoid humiliation, every participant was highly motivated to adopt healthy behaviors in order to reach the goal, and in the end, everyone was successful.

What does this anecdote have to do with improving site selection in the clinical trials industry? As it turns out, quite a lot. Using transparency -- that is, placing information out there for all to see -- can be an enormous motivator of behavior that ultimately impacts performance. It is this reality that one emerging startup, TrueTrials, is exploiting to make meaningful improvements in how sponsors and contract research organizations (CROs) select investigative sites. Finding sites that can perform -- i.e., recruit the contracted number of study volunteers and generate clean clinical trial data -- remains one of the key challenges in clinical development. Studies suggest that only 20 to 30 percent of sites perform as promised.

TrueTrials, a privately held company based in San Mateo, CA, is about to launch a Web-based system that is using transparency to address this major challenge. The company's vision for the long term is to enable high-performing sites to build solid reputations, eBay style, by documenting their performance. To accomplish this, TrueTrials invites investigative sites to enter their performance data online as a clinical trial unfolds. Over time, a database will be established that will clearly identify which sites are performing in which therapeutic areas. Both the better-performing and lesser-performing sites will eventually become highly visible as their composite information will be made available for the clinical trials community to see. The expectation is that sites will be motivated to perform as expected to maintain a good rating, or else opt to walk away from a potential study in which they are unlikely to succeed. "Sites will need to be brutally honest with their self-assessment for performing successfully on a trial. There will be nowhere for poorly performing sites to hide," says Sooji Lee-Rugh, M.D., CEO and co-founder of TrueTrials.

Sponsors and CROs will be able to verify the accuracy of the entered data for their own studies because they will have access to that data in real time, and will have the enrollment logs from the sites as a second source of data verification. All compiled information about trials from other sponsors and CROs will, of course, be blinded.

TrueTrials' next major release of its technology platform is expected in the next few months. Chief Technology Officer David Chan says the new release will use Asynchronous JavaScript and XML (AJAX) technology to improve user experience and to simplify a sponsor's or CRO's search for appropriate sites. 

With the new release, the company will start populating its database with lists of investigative sites that are currently available in the public domain. TrueTrials will contact the sites to advise them of the listing and to verify the accuracy of the information. Sites will also be invited to register with TrueTrials by completing a detailed application that will enable sponsors and CROs to locate desired traits when they perform searches. Sites that register will receive an evaluation of the completeness of their entry, which will determine how they will rank in the search. "Even this first step is intended to create motivation for sites to complete as much information as possible because it will increase the visibility of their site," says Lee-Rugh.
 
Searches by sponsors and CROs will be available in two levels of detail. For those who simply want to visit the TrueTrials website and perform a quick search, they can jump in by entering some basic search criteria. For a more detailed experience, sponsors and CROs can register as members, which will give access to more comprehensive information such as a site's experience with Phase I trials, details on patient population, or the frequency with which a local institutional review board (IRB) meets. TrueTrials is eager for sites, sponsors, and CROs to register so they can begin to use the system and provide feedback.

"The focus of our site selection technology is to provide a tool for sponsors and CROs to perform the best search and make the best matches possible. Instead of sponsors driving the site selection process based on fragmented information, sites will be able to level the playing field by providing data that will be of interest to sponsors who may not know about them. This will benefit all stakeholders who want to see changes in how sites are selected," says Lee-Rugh.

FEATURED EVENTS

MIT Advanced Study Program  -  Register for Fall 2007
The Massachusetts Institute of Technology Advanced Study Program (ASP) is now accepting applications for the Fall 2007 term.  ASP provides full and part-time certificate programs to working professionals at any stage of their careers. The program includes a flexible curriculum of MIT courses designed around the goals of participants and their sponsors. To fill out an application, view a five-minute video that describes the ASP program, or request an information packet, visit http://web.mit.edu/mitpep/go/asp07-bioit.html .

To have your event featured here, contact Lynn Cloonan for more information.