New Tools for Digitally Run Clinical Trials


By Mark D. Uehling Bio-IT World
Target Health is a double role model. It is showing where both leading technology vendors and fearless contract research organizations (CROs) need to migrate.

As a small, focused, service-oriented CRO, the company knows how to take care of customers ranging from mid-tier biotechs to large pharmas that claim to be standardizing around other technology vendors.

But Target Health is itself a technology company, giving its own software an unusual amount of internal resources and attention. The company takes a release of its core application as seriously as any electronic data capture (EDC) concern. As with much larger EDC innovators, Target Health is exploring both e-source – paperless or almost-paperless data entry – and integration with hospital and physician-office IT systems.

The Manhattan company has just released version 3 of Target e*CRF, a suite of tools for setting up and running clinical trials digitally. The origins of Target e*CRF lie in its own experiences serving sponsors and gathering data. Denmark’s Ferring Pharmaceuticals has already had two NDAs approved with earlier versions of Target’s tools. Ferring says it locks its databases a single day after the last patient visit.

Target Health’s president, Jules Mitchel, is not a fan of software for the sake of software. “Drug development and device development are our business,” says Mitchel. “We make presentations to companies without demonstrating our software. We say, ‘This is what we have done.’ Customers want someone who can help them solve problems, not just make software.” Within e*CRF there is a WYSIWYG editor to create case report forms, and the SAS programming language for edit checks.

The key thing for sponsors, Mitchel says, is that no additional proficiencies will be required by a clinical research associate (CRA) or statistician using the tools. Says Mitchel: “For companies to use our software, they do not need to change the current skill sets employed by the company. The skill sets of a good CRA or SAS programmer are the fundamental skills needed to run our system.”

Mitchel’s VP for business development, Bill Johnson, formerly participated in EDC development at Merck. He believes Target Health is something of a new breed of companies, an e-CRO. Target Health’s technology is sufficiently flexible, Johnson says, to have two different departments in the same company using his software to design trials in their own preferred ways.

Yes, that might seem ill-advised to senior managers in, say, the financial services industry. But in pharma, it’s not top secret that teams dedicated to different diseases or types of trials often have idiosyncratic groups of preferences, standard operating procedures, and even color schemes. All of the above are invariably not shared by colleagues within the same company. Says Johnson of customers: “They can change our system to match their process.”

Joon You, Target Health’s chief technology officer, adds that the system can store the data in any common format. “The system can archive the data natively in XML and also PDF and SAS datasets. It does all three automatically, and there are other formats you can specify like Excel spreadsheets.”

Click here to login and leave a comment.  

0 Comments

Add Comment

Text Only 2000 character limit

Page 1 of 1

White Papers & Special Reports

definiens briefingon-76Next-Generation Technologies Revolutionizing Oncology and Diagnostics
underwritten by Definiens

This “Briefing On” collection of Bio-IT World features, commentaries and analysis, presents some of the latest thinking on high-throughput technologies that are being applied to the fields of research and drug discovery, with particular emphasis on oncology, diagnostics and imaging technologies. Download now at no charge compliments of the underwriting sponsor, Definiens. Download This Free Paper



gq nxt gen seq

This Bio•IT World Briefing On “Next-Generation Sequencing,” underwritten by GenomeQuest, Inc.,
presents a selection of feature stories, interviews,commentaries, conference reports, and editorials on the emergence, opportunities, and challenges posed by high-throughput sequencing. Covered in this collection: the launch of new platforms from Applied Biosystems and Helicos; new applications of nextgen sequencing; the rise of personal genomics; and informatics solutions to vexing problem of managing the vast volumes of next-gen data.  Download now 



Life Science Webcasts & Podcasts

GenoLogicsgenologics 2 translational
Enabling Translational Research Informatics

Learn about the challenges facing life sciences research labs to manage their translational research data:

  • The trends for organizations to adopt informatics solutions for translational research.
  • The unique requirements with managing complex data and workflow.
  • What labs should consider when reviewing informatics solutions for translational research.
  • Which life sciences research organizations are successfully adopting an informatics solution.

Download Now



More Podcasts

Job Openings

Assistant Editor (Science Writer)~Cambridge Healthtech Institute (CHI), Needham, MA, 
Cambridge Healthtech Institute seeks an assistant editor (science writer) who is an ambitious, dependable journalist who can fulfill a range of writing and editorial duties for a series of eNewsletters covering various aspects of the biopharmaceutical industry in addition to CHI’s flagship publication, Bio-IT World magazine.  This is a superb opportunity to make important contributions to the growth and success of a multimedia science publishing group, while gaining invaluable experience in multiple facets of the publishing industry.   Interested candidates should submit a cover letter, including 3 writing samples (attached in Word or PDF format), salary history or requirements, and resume to kdavies@healthtech.com. 

Fred Hutchinson Cancer Research Center: IT Business Analyst III
The Hutchinson Center is the only National Cancer Institute-designated comprehensive cancer center in the Pacific Northwest. Through our Tumor Research Initiative, we are finding new ways to detect tumors at an early stage.  We are presently seeking an experienced IT Business Analyst to assess technology needs for the Tumor Research Initiative, and to identify and design improvements to computer based systems.  For more information please visit www.fhcrc.org and search for Job# AD-21465

For reprints and/or copyright permission, please contact RMS, 1808 Colonial Village Lane, Lancaster, PA;

(717) 399-1900 ext 100 or via email to bio-itworld@theygsgroup.com.