Phase Forward and ClinPhone Integration Driving Clinical Data Management Efficiencies Worldwide
Phase Forward Incorporated, 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 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— Patients who are registered or withdrawn via Phase Forward’s InForm system will automatically be registered within or withdrawn from ClinPhone’s IVR database.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.”
“The integration of ClinPhone and Phase Forward technologies is in response to customer requests made of both companies,” commented Dr. Howard Goldberg, Vice President and General Manager at ClinPhone Inc. “We are gratified to see that the vision of managing clinical study processes more efficiently is being achieved by many forward-thinking Sponsors who have embraced our joint offering.”
“With this strategic partnership, Phase Forward and ClinPhone are providing one synergistic system, empowering sponsors and site users to simplify their clinical processes and cut costs. This integration delivers a significant return on the investments customers have made in our companies’ respective solutions,” said Kathryn Roy, Vice President of Marketing at Phase Forward. “By creating an integrated clinical trial environment, that leverages decades of expertise and industry leading technology solutions, we are helping our customers to conduct clinical trials faster and smarter.”
About Phase Forward
Phase Forward is a provider of integrated enterprise-level software products, services, and hosted solutions for use in the clinical trial component of its customers’ global research and development initiatives. Phase Forward’s customers include pharmaceutical, biotechnology, and medical device companies, as well as academic institutions, clinical research organizations, and other entities engaged in clinical trials. By automating essential elements of the clinical trial process, the Company believes its products allow its customers to accelerate the market introduction of new medical therapies and corresponding revenue, reduce overall research and development expenditures, enhance existing data quality control efforts, and reduce clinical and economic risk. Phase Forward believes its enterprise software and hosted solutions are the most widely adopted commercial data capture, data management, and adverse event reporting solutions in the clinical trial marketplace, having been utilized in over 10,000 clinical trials involving more than 1,000,000 clinical trial study participants and 300 therapeutic compounds and medical devices. Phase Forward’s customer base of over 220 customers is comprised of the leading pharmaceutical, biotechnology, medical device, and clinical research organizations, including AstraZeneca Pharmaceuticals LP, Aventis S.A., Biogen Idec Inc., Eli Lilly and Company, GlaxoSmithKline plc, Guidant Corporation, Institut de Recherches Internationales Servier, Pfizer Canada, The Procter & Gamble Company, Sanofi-Synthelabo, Schering-Plough Research Institute, and Serono S.A.. Phase Forward is headquartered in Waltham, Massachusetts with offices in the United Kingdom, Australia, France, and Japan. Additional information about Phase Forward is available at www.phaseforward.com .
About ClinPhone Group Ltd
ClinPhone is the largest and most experienced Clinical Technology Organization (CTO) in the industry, having supported well over 1000 clinical trials (of which more than 300 are currently live) in over 80 countries and 70 languages.
Since 1993 the ClinPhone brand has become synonymous with randomization and medication management services powered by Interactive Voice Response (IVR) technology and this has resulted in no less than 17 coveted preferred supplier agreements. The company has extended its product portfolio significantly during the last two years and now offers sponsors a comprehensive range of electronic trial management solutions:
— Interactive Web Response (IWR) – The web-based equivalent of ClinPhone’s market-leading IVR service
— Electronic Patient Reported Outcomes (ePRO) – Patient diaries, instruments and assessments administered by patients using the standard telephone
— Patient Recruitment Solutions – Internet patient data capture, IVR Screening and traditional advertising combined to produce a powerful patient recruitment tool
— Clinical Trial Management Software (CTMS) – ClinPhone’s latest acquisition is a pragmatic software product that enables clients to manage multiple numbers of studies from their own desktop
ClinPhone has further extended its reach by providing robust integration solutions to give clients access to real-time randomization, medication management and patient diary data through outsourced and in-house software products. This has proved highly successful and many Sponsors are taking advantage of real-time data availability via integrations with best-in-class EDC, CTMS and Drug Supply Management software.
The company has over 400 staff with over 100 employees out of U.S. offices in Princeton, New Jersey; Chicago, Illinois; Boston, Massachusetts and Saratoga, California. European facilities are located in Brussels, Belgium and Heidelberg, Germany with corporate headquarters in Nottingham, United Kingdom. Visit www.clinphone.com for further information.
