Clinical Research Technology News (Winter 1998)

In this column of the special Technology Issue, we are providing our readers with news on recent developments in clinical research technology. Contact numbers are given where possible. This information has been gathered by the Editor to the best of his knowledge at time of publication. For more details, call the companies mentioned.

The most exciting developments in clinical research technology in 1998 are likely to revolve around the use of the Internet, as people experienced in clinical research apply their expertise to use the Internet in appropriate ways. The Web is already playing a role in patient recruitment and investigator identification, led by CenterWatch and others. There are several new initiatives underway in Web-based trials management and electronic data collection (EDC). Some are just ideas, others have been released, and at least one company is backed by major funding wth significant plans which show great promise. It’s early days, but this picture should begin to become clear by the March DIA meeting on clinical data management in Philadelphia and the ACRP Annual Meeting in May.

At the Executive Retreat on Technology in October, Anderson Clinical Technologies showed an innovative, low-cost patient diary system based on their punch-card technology used for drug compliance; (847) 392-9190.

AVANTEC continues to enhance its already comprehensive service offering for collecting and managing data electronically. It has added a significant new suite of trials management tools to its overall service offerings; (800) 574-8610.

Battelle and Boston Healthcare Associates have formed a joint venture to create a clinical data warehouse based on the cooperative pooling of data from major managed care organizations and health systems. This could have a significant impact on outcomes research (617) 912-5170.

Domain Solutions has announced the long-awaited release of Clintrial 4.1. ClinTRACE is claimed to be the leading Adverse Event system in terms of number of customers. The Clintrial 4 development partners report slow going in the transition to the new product. Meanwhile the company has seen significant executive management turnover, and is in the process of ongoing consolidation following the absorption of Presidio (an EDC vendor); (919) 547-7070.

DLB Systems has been acquired by Premier Research Worldwide, a publicly held CRO. Coincident with this has been the strengthening of the company’s management team with new players. Premier’s financial strength, CRO services, and longstanding expertise in collection and submission technologies make the Premier/DLB combination unique. DLB’s Web-based site entry solution is being beta tested for formal release later in 98; (800) 879-0352.

IBM is making news with its new partnership with PPD Pharmaco’s Belmont Research unit. IBM will be reselling Belmont’s software products and Belmont will be working on extending IBM ClinWare beyond EDC and trials management. IBM is reported to be making inroads at major pharmaceutical companies with its EDC product to challenge TechniLogix (see below) for the leading EDC position. Glaxo Italy had reported it is piloting a Web version of ClinWare. IBM also supports the DataTRAK services company through providing ClinWare software, hardware support and network connectivity through the IBM Global Network; (617) 895-2834.

TechniLogix, Inc., an EDC vendor, now claims almost 3000 sites are current users of their Quest software in active trials. At least 4 major pharmaceutical companies are using their software in multiple, multisite, global trials and the company remains the only EDC vendor with practical experience in multinational Phase III trials of any real scale; (201) 840-1212.

The pharmaceutical unit of SAIC (Science Applications International Corporation), the country’s largest employee-owned technology company, has completed two important projects this year: it has ported its patient recruitment system (a robust Oracle-based system with call center support) to Windows NT for an SMO, and it is completing the first full-featured EDC system built in SAS, this for a pharmaceutical company; (937) 431-2261.

Viacron Inc, a disease management technology firm, has an FDA-approved device which could be applied to patient diaries. It may be the best combination of low cost, interactive communication between study coordinator and patients, and sophisticated graphical reports of any other offering; (612) 920-1651.

Site-specific software remains an underserved market. Advanced Clinical Software has a new version of Study Manager and a new service called E-Trial; (206) 230-8225. Integra Systems Design has been developing a significant product now in testing; (334) 433-4400. Premier/DLB is exploring how its Field Monitor product could be better adapted to site-specific uses; (800) 879-0352.