Phase Forward and ClinPhone Integration Driving Clinical Data Management Efficiencies Worldwide

Business Wire, July 27, 2004

WALTHAM, Mass. & NOTTINGHAM, United Kingdom -- P&G and Kos Pharmaceuticals Realizing Benefits of Best of Breed Integrated EDC/IVR Platform

Phase Forward Incorporated (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, and the industry's foremost Clinical Technology Organization (CTO) ClinPhone Group Ltd., announced today that the integration of Phase Forward's InForm(TM) electronic data capture (EDC) solution and ClinPhone's Electronic Trial Management (ETM) solutions are delivering tangible benefits for customers worldwide. The companies offer an integrated solution to empower Sponsors with a single platform for the collection, management, and exchange of clinical data. Today leading pharmaceutical and biotech companies - including Procter & Gamble Pharmaceuticals and Kos Pharmaceuticals - are leveraging the integrated solutions to eliminate unnecessary steps in the clinical process and conduct trials more efficiently, more rapidly, and more cost-effectively.

As Sponsors and site users have become more comfortable with technologies such as EDC and Interactive Voice Response (IVR), they have sought ways to increase their return on investment. One effective way to reap additional benefits from these technologies is to take advantage of the fact that they often 'touch' the same data points - such as randomization codes, patient status, and stratification factors. Although clinical applications may have many common data points, when not integrated, they result in unnecessary inefficiencies. For example, an investigative site coordinator may enter patient demographics into an IVR database and later enter the same demographics into an EDC system. Not only does this involve a redundant task for the site staff, but it also creates the possibility that discrepancies may occur. This, in turn, leads to more queries and an inefficient use of site and sponsor time.

The integration of Phase Forward's InForm(TM) solution and ClinPhone's IVR system has avoided these pitfalls and offers the following benefits:

--Patients who are registered or withdrawn via Phase Forward's InForm system will automatically be registered within or withdrawn from ClinPhone's IVR database.

--Based on stratification and baseline data entered via the eCRFs, patients can be centrally randomized using the IVR system without having to reenter the eCRF data.

--Once patients are randomized using the IVR system, critical information is automatically updated in the InForm system database.

--Patient diary data collected using ClinPhone's Patient Direct(TM) can auto-populate diary eCRFs within the InForm system, enabling real-time evaluation of diary data.

Procter & Gamble Pharmaceuticals is currently leveraging the EDC/IVR integration for patient screening and enrollment. Previously, a site coordinator would create a case book, and then populate the case book with patient data. The same steps would then take place in the InForm system. Through the integration, screening and enrollment is handled through the IVR system and imported into the InForm solution. When a site coordinator now logs into the InForm system, patients have been enrolled, case books have automatically been created, and only patient data entry is necessary. Site burden is reduced as the clinicians do not have to transcribe diary data, calculate diary scores, or enter screening and demography information twice.

"Individual technologies can solve a number of challenges, but we all know that anytime data is entered into disparate systems, there lies the risk of creating discrepancies," said Rennie Castelino, Clinical Data Manager of Procter & Gamble Pharmaceuticals. "The integrated InForm/ClinPhone IVR platform enables us to take full advantage of each solution's capabilities, while eliminating areas of duplication. With the integration, our IVR calls have been shorter and EDC entry has been simplified. The IVR patient diaries populate the eCRFs and clinical investigators can view the data in real time. In short, we've further improved data quality and accuracy, reduced site workload, and streamlined and accelerated workflows."

As part of a 1,300-patient study, Kos Pharmaceuticals leveraged the integrated solution to simplify data capture processes at the sites. By integrating the EDC and IVR systems, Kos was able to streamline and simplify the workflow for site coordinators and eliminate redundant processes. The InForm software accelerated Kos' collection of vital clinical data, while ClinPhone's IVR helped Kos to efficiently manage a very complex medication supply chain. "Our site coordinators were extremely enthusiastic about the integration of the Phase Forward and ClinPhone systems. As the site coordinators manage a significant amount of data for each trial, solutions that help eliminate discrepancies and increase efficiency are invaluable," said Craig Amburgey, Associate Director of Clinical Research at Kos. "Overall we gained time and resources that could be put toward other product development initiatives."