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Parexel launches e-clinical solutions platform for late phase trials

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Tuesday, April 6, 2010, 16:44 This news item was posted in Clinical Trials category and has 0 Comments so far.

Parexel International Corporation, a leading global biopharmaceutical services provider, has introduced a new web-based technology platform for late phase clinical research for the biopharmaceutical industry.

Web-based technology platform technology brings greater cost effectiveness to conducting large-scale studies and facilitates highly efficient capture of global safety and health outcomes data in a real world setting.

The platform allows for a broad range of eClinical solutions, such as Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), Randomization and Trial Supply Management (RTSM), and Electronic Patient-Reported Outcomes (ePRO), to be incorporated in late phase studies for optimal data integration.

The solution integrates the innovative strategies and proven processes of Parexel’s PACE (Peri Approval Clinical Excellence) team with eClinical solutions from Perceptive Informatics, Parexel’s technology subsidiary.

Biopharmaceutical companies require much greater efficiency in managing the high volume throughput of data while controlling the costs related to these programs.

The new approach helps biopharmaceutical companies ensure higher data quality, accelerate better decision-making, and achieve faster determination of evidence-based health outcomes in late phase clinical research, Parexel said in a news release.

“A variety of late phase studies, including observational studies and patient registries, are being used as either primary or adjunct vehicles for pharmacovigilance and health evaluation activities in order to meet increasing regulatory and payer demands for long-term safety and health outcomes data,” stated Carol Collins, Ph.D., corporate vice president and Worldwide head of PACE, Parexel International.

The platform includes a streamlined user experience with single access; an intuitive interface with functionality for site self registration and management; an automated cues for unique late phase site requirements to enable improved compliance; enhanced reporting capabilities including site-based features such as investigator payment status reports and centralized access to data including site, patient, and clinical supply information

Parexel’s PACE (Peri Approval Clinical Excellence) team has conducted over 600 late phase studies, throughout 76 countries, which have involved more than one million patients and over 90,000 physician sites over the past five years.

Parexel plans demonstrations of the platform during the Partnerships in Clinical Trials Conference to be held April 12-14, 2010 in Orlando, Florida.

Parexel International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, medical communications and consulting services to the worldwide pharmaceutical, biotechnology and medical device industries.

Perceptive Informatics, Inc., a subsidiary of PAREXEL, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process.

Parexel’s late phase capabilities include Phase IIIb and IV clinical trials, observational studies, registries, expanded access programs, risk management programs, post approval safety surveillance, and comparative effectiveness research as well as health economics and outcomes research consulting.

Headquartered near Boston, Massachusetts, PAREXEL operates in 71 locations throughout 50 countries around the world.

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