Latest clinical research partnerships
Covance and ISB team on brain tumour biology
US contract research organisation Covance will work with the Seattle-based Institute for Systems Biology (ISB) to elucidate the genetic mechanisms behind glioblastoma multiforme.
The research project, terms of which were not disclosed, will combine the respective organisation’s capabilities in genomics with Covance providing assay and sequencing services.
Covance acquired its genomics laboratory from US drugmaker Merck & Co in 2009. In January the facility gained Clinical Laboratory Improvement Amendment (CLIA) certification from the State of Washington Department of Health.
Emergo and Data Pharma
Emergo Group and Data Pharma have partnered to set up a medical device focused clinical trial service in Japan to cater for growing industry demand.
The new entity, which will be based Emergo’s office in Tokyo, will provide trial management and consulting services designed to help device manufacturers navigate the unique challenges of Japan’ complex regulatory environment.
One of the major challenges is that Japan’s Pharmaceutical and Medical Devices Agency (PMDA) frequently requires that device manufacturers prove the efficacy and safety of their products via trials conducted in the country
Embago CEO Michiharu Miyahara said: “The Japanese government has a strategy to drive growth in the life sciences industry, but this has been challenging due to the complexity of conducting clinical trials in Japan which are sometimes needed to obtain regulatory approval.
“There are very few consultancies specializing in medical device clinical trials in Japan so we are addressing this growing need. Our team is eager to start helping manufacturers conduct clinical trials for their products prior to commercialization in Japan.”
Integra joins RxTrials US network
The Integra Clinical Research facility in San Diego has become the latest addition to RxTrials’ US research network.
Integra, which has links with the Neurological Institute of San Antonio, is a dedicated Phase II to IV study site that specialises in trials in central nervous system (CNS) disorders.
The facility is the eighth clinical trial site that Elicott City, Maryland-headquartered RxTrials’ has partnered with, across four US states.
Integra president Suzanne Gazda said: “Our model fits nicely with RxTrials because all the RxTrials sites are located within established clinical practices which provides an immediate pool of potential study volunteers and enhances retention dramatically.”
