etrials Inc.
This article was originally published in Start Up
Executive Summary
A little younger than some of its competitors in the electronic data capture world, etrials Inc. has nonetheless made a name for itself since its 1999 founding. Revenues are up, its list of customers is growing and the European marketing is beckoning for its integrated suite of products designed to streamline clinical trials for biotech and Pharma clients.
High touch EDC
2701 Aerial Center Parkway, Suite 100
Morrisville, NC 27560
Phone: (919) 653-2000
Fax: (919) 653-2001
Web Site: www.etrials.com
Contact: John Cline, President
Industry Segment: Clinical Information Systems
Business: Electronic clinical trial data capture and management
Founded: September 1999
Founders: John Cline; Doug Pietrowski; Travis Jackson
Employees: 70
Financing to Date: $8 million
By now, the numbers are deeply ingrained: clinical trials consume most of the $800 million that it takes to get the average drug to market. And each day a trial is delayed, for whatever reason, costs its sponsor $1 million. These figures have long been bandied about to promote web-based technologies for streamlining various aspects of the trial process. Offerings range from tools for patient recruitment, electronic patient diaries, software to drive patient compliance, and electronic data capture (EDC) systems—integrated suites of products for managing clinical research data, from deployment through database lock.
By enabling real-time access to the mountain of data collected in clinical trials, EDC allows sponsors to monitor trials as they unfold. Such immediate feedback is increasingly important: up to 70% of the billions spent on R&D go to drugs that don't make it to market. If a sponsor finds out within weeks, rather than months, that a compound is ineffective, it can make a much earlier go/no go decision.
But implementing EDC is more than just replacing paper with software—it requires a reworking of the entire trial process. For that reason, the industry, Big Pharma in particular, has been slow to embrace it. But EDC is starting to gain a foothold. Pundits disagree on the speed of adoption, but most believe that one-fourth to one-half of all US clinical trials will employ EDC by 2005.
etrials Inc. may not been around as long as some of the other EDC players—CB Technologies Inc., Phase Forward Inc. , or Datatrak International Inc. —and it may not have raised as much money, but there is no disputing that it is off to a promising start. The company has enjoyed consistent triple-digit revenue growth. Year-to date sales, as of June 30, 2002 were 177% higher than the same period in 2001. Co-founder and president John Cline reports that etrials is poised to break even this fall, a mere three years after it was formed.
Cline was first exposed to electronic trial technology during a stint in the mid-90s as VP of sales and marketing at Sweden's Minidoc AB, which at the time was an electronic patient diary (EPD) vendor. Frustrated by what he perceived as archaic technology, Cline and Minidoc colleagues Doug Pietrowski and Travis Jackson formed Expidata in January 1999 to build a better solution. Nine months later, they merged Expidata with PharmaCentric Inc., which had a trial management system, and subsequently renamed the new entity etrials.
The company has focused from its inception on building scalable technology. Unlike some other EDC players, which do a significant amount of original programming for each study (and maintain large programming staffs), etrials has developed software toolkits that can be easily customized for each trial.
The result of their efforts is QuickStudy, a suite of tools and services designed to handle all aspects of clinical trial data collection and management. The process begins with QuickStudy Start, etrials' process for interviewing the client's team, evaluating the trial protocol, and identifying all of the necessary data points. That information is developed by QuickStudy Build, user-friendly software for creating case report forms (CRFs) and database entry screens.
Once the trial is underway, investigators enter patient data in QuickStudy Capture, which etrials claims offers the fastest page turns in the industry. It is not unusual, Cline says, for some EDC systems to have 30-40 second delays in page turns. etrials averages five seconds, even over dial-up phone connection from overseas.
QuickStudy Capture also offers rapid edit-checking to instantly verify data quality. These edit-checks require complex algorithms that can slow the performance of system. etrials CompiledCheck technology compresses and compiles edit checks, Cline says, and deploys them up to 500% faster than the industry norm.
QuickStudy Log is the patient diary system. etrials offers trial participants handheld electronic diaries—licensed from Hewlett-Packard—to record symptom and quality-of-life data. And investigators use the Log to capture clinical data. QuickStudy Log is the first EPD to offer mid-study changes, Cline says. If, in the course of the trial, the client realizes it needs to collect more data, etrials is able to automatically synch the additional data points into diaries overnight as they are cradled. Other EPD systems require trial participants to bring the handheld unit to the investigator's site or mail them to the CRO or sponsor for reprogramming.
QuickStudy View is a secure web-based reporting tool that gives sponsors and investigators real-time access to clinical trial data, enabling them to monitor results, evaluate progress, generate reports, and tweak the process if necessary.
etrials has applied for three US patents on its technology: for its QuickStudy Start process, its edit-checking capability, and its mid-study EPD changes.
Cline emphasizes that etrials is much more than its software tools. Its service component, QuickStudy Touch, encompasses consulting, training, customer support, and data management—approximately 80% of etrials clients assign data management duties to them, Cline says, rather than a CRO.
Cline says that etrials is unique among EDC vendors in its emphasis on blending clinical expertise with technology. Almost one-half of etrials' staff is focused on clinical operations, a much higher ratio, he believes, than its competitors. "It is important to be both high touch and high tech," says Cline, "especially at this relatively early stage in EDC adoption."
etrials insists on guiding clients through the process of using the technology. "We've had clients who say, ‘we just want to buy your software and the manual—leave us alone,'" Cline says, "but we won't do it." The company wants to avoid the risk that untrained clients might implement the QuickStudy tools in a way that doesn't accurately reflect the capability of the software. Not that etrials won't back away over time. The QuickStudy software is optimized for follow-on studies—study logic and data entry screens are reusable. etrials is more than willing to minimize handholding in subsequent trials, once the client has instituted the necessary process changes and is comfortable using etrials' tools.
Sixty percent of etrials' business is from repeat customers. Particularly impressive, Cline says, when you consider that most of its clients are biotech companies with just one compound. He estimates that biotechs comprise 80% of etrials' client base—20% of them large biotech companies—and the rest are pharmaceutical companies.
etrials charges its clients for set-up services and an ongoing software license fee. Cline says etrials' prices are among the lowest in the industry, and comparable to running a paper-based trial. "Price has never been much of an issue for our clients," he says. "When you are able to a deploy trial in as little as six weeks from the initial meeting and compile a locked database in days from the last patient visit, the results speak for themselves."
The company sells its software and services directly, but is also eager to partner with CROs: it has a preferred software vendor marketing agreement with Cato Research and recently signed another with Dublin-based CRO Eclipse Clinical Technologies Ltd.
It is also partnering with Eclipse to penetrate the European market. Although many of its client's trials have had an international component—its very first EDC client was a multinational firm based in Australia—etrials is poised to make a big push in Europe, which most believe is now ready to embrace EDC. Eclipse will provide sales and technical support, as well as customer service to etrials' European clients. The first trial for the partners is an international 6000 patient study with 270 sites, including 50 sites in seven different countries. Cline says that it is particularly important to partner well in Europe because of the cultural and regulatory differences. And technical barriers remain: there are some countries—Italy for one, says Cline—where connectivity can be a problem. "We have told clients that EDC may not be their best option there."
Indeed, Cline is more than willing to be blunt with clients or potential clients if he doesn't think EDC, or etrials, is the best solution for a particular trial. "We won't take on work if we can't do it well," he says. "For us to succeed, we need our clients to succeed—we want them to be able to tell their colleagues, ‘I locked my database in weeks vs. months because of etrials.'" It all comes back to what he calls high touch: "We'll do whatever it takes to make our clients happy," says Cline, "at the end of the day, it's all about the service."
etrials has raised $8 million from angel investors, lead by Tryon Capital Investment Partners. Despite its anticipated near-term profitability, the company is looking to raise another $5 million from high net worth investors to accelerate and support its European launch.—NTD