PharmaLinkFHI Implements Phase Forward's Internet-Based Data Management Solution, Speeds Clinical Study in Nepal

Business Wire, Feb 26, 2001

Business/Technology Editors and Healthcare/Pharmaceutical Writers

WALTHAM, Mass.--(BUSINESS WIRE)--Feb. 26, 2001

-- Phase Forward's InForm(TM) Solution Enabled PharmaLinkFHI to

Dramatically Accelerate Data Capture, Ensure Data Accuracy and

Eliminate Language Barriers --

Phase Forward Incorporated, the pioneer in proven eProcess solutions for accelerating global pharmaceutical development, announced today that Family Health International (FHI) and its commercial affiliate, PharmaLinkFHI (PharmaLink), successfully completed a clinical study in Kathmandu, Nepal using Phase Forward's flagship Web-based solution. With the InForm solution implemented by PharmaLink, FHI was able to access, analyze and report clinical data, allowing the completion of this family planning study well ahead of schedule.

"The study gained a lot from the InForm system. Local data entry, combined with timely query generation and resolution cut out an activity loop that would be very cumbersome with a paper-based system," said Hanif Nazerali, FHI senior research associate. "By using this internet-based application to capture data electronically, we reduced the number of unresolved queries and secured more reliable data, earlier in the process."

A traditional paper-based process would have required that data forms be sent via courier to FHI's headquarters office in North Carolina, where the data would have been hand-entered. The resulting data change requests would have to go through at least one round trip by courier. Because data review requires that this loop be repeated until each data item is approved, data capture and cleaning for this trial would have taken months longer without the InForm solution.

In addition, since the interview forms were in Nepalese, employing a system that enabled local data entry eliminated a potential language barrier. Bilingual study personnel effectively resolved queries and FHI was able to ensure much greater accuracy of the data. Moreover, the InForm system enabled real-time validation of the laboratory calculations that determined the primary study outcome, and facilitated laboratory QA by the U.S.-based FHI laboratory consultant.

"PharmaLinkFHI is a highly innovative organization, using the InForm solution and the Internet to the strategic advantage of its customers," said Bruce Press, vice president ASP Services of Phase Forward Incorporated. "With this study, PharmaLink and FHI have shown that global Internet connectivity can significantly reduce the cost of conducting international studies. We can now enable Internet data collection and management worldwide, including many locations in Asia, Africa and South America. This dramatically opens the potential for new study sites."

"Paradoxically, these new research sites will adopt new technologies quickly and willingly, because they have not invested heavily in conventional data management systems. As they expand, they recruit from a younger cohort who are far more comfortable and conversant with information technology than those of us in established research organizations," said Hanif Nazerali, who is based at Family Health International headquarters in North Carolina. "The challenge, as I see it, is ensuring that this new Internet-based application is available to those clinical researchers who can make a significant contribution to the health of the majority in Africa, Asia, and South America."

Phase Forward's InForm solution enables pharmaceutical companies to bring drugs to market faster by accelerating the collection and management of high quality clinical trial data. The technology is designed to meet the rigorous requirements of the highly regulated drug approval process. The InForm solution is the most widely used Internet-based clinical data management solution.

About Phase Forward

Phase Forward Incorporated is the pioneer in proven e-process solutions for accelerating global pharmaceutical development. Phase Forward's InForm software product uses Internet technologies to conduct and manage clinical trials efficiently and effectively. The InForm software product has been used in over 130 clinical trials worldwide. Our software and service solutions allow sponsors of clinical trials to eliminate the need to transcribe and process traditional paper data forms, to access global clinical trial data in real-time, and to begin data analysis almost immediately after the last patient has visited the clinic. Phase Forward believes that use of its InForm software product by clinical trial sponsors has the potential to cut one to two years off the current seven to nine years it takes to bring new drugs to market, enabling them to increase their revenue potential. Phase Forward Incorporated, a privately held company, is headquartered in Waltham, Mass. Additional information about Phase Forward is available at http://www.phaseforward.com.

Phase Forward and InForm are trademarks or registered trademarks of Phase Forward Incorporated. All other trademarks may be the property of their respective owners.