Friday, June 29, 2007
The Association for the Accreditation of Human Research Protection Programs (AAHRPP) has accredited its largest group of institutions at one time in its six-year history. In total, 16 organizations gained AAHRPP approval. The certification is valid for three years. The AAHRPP is a non-profit organization that offers accreditation to organizations that conduct or review research with humans.
Maryland-based CRO United BioSource Corporation (UBC), in conjunction with eClinical firm Medidata Solutions, and the adaptive trials tools and modeling company Tessella, have joined together to educate the industry on the use of adaptive clinical trials in drug development. The companies are producing a series of free webinars—six in total—that will feature expertise from industry professionals and regulatory authorities on how to overcome some of the challenges of these studies.
NovaCardia reported positive preliminary results from a phase III trial of KW-3902 for the treatment of acute congestive heart failure (CHF). This double-blind, randomized trial enrolled 304 subjects with CHF and renal impairment. Subjects received placebo or 10, 20 or 30 milligram doses of intravenous KW- 3902, administered daily for up to three days. All subjects received intravenous furosemide.
Dublin-based ICON Clinical has established a new business unit called its lifecycle sciences group, focusing specifically on outcomes research and economic analysis services. The news was announced during the Drug Information Association (DIA) 43rd Annual Meeting in Atlanta. The group will work with stakeholders across the client organization in area such as clinical development, but also with sales and marketing, medical affairs and strategic development groups—units where most contract research organizations (CROs) have less interaction with.
Waltham, Mass.-based contract research organization (CRO) Parexel International has opened a major clinical operations and data management office in Hyderabad, India. The office will serve as the company’s main hub in the region and will expand its presence in the emerging Indian clinical trials market. Although Parexel already operates an 86-bed phase I unit in Ahmedabad, through a joint venture with the CRO Synchron, this would be the company’s first late phase clinical operations office in the region.
India continues to be a country where investment in contract research is hot. A deal announced Monday is a big one.
Newton, Mass.-based patient recruitment company BBK Worldwide has created a new company division called the global mobilization team. The company stated that this division will help address the challenges of planning and deploying of resources for large-scale, global trials. BBK stated the division will include in-country staff with expertise in local patient recruitment, a web-based communication structure and real-time access to data essential for making changes in recruitment operations mid-trial.
Mumbai-based Wellquest CRO, the clinical outsourcing division of India pharmaceutical company Nicholas Piramal, opened a 30,000 square foot research facility in Hyderabad. The 112-bed center boasts separate wards for female and pediatric subjects. The unit will be Wellquest’s second facility in India, which runs a 20,000 square foot center at the Wellspring Hospital in Mumbai. The Mumbai facility consists of a 60-bed ward, six-bed ICU, pharmacy, phlebotomy stations, bioanalytical laboratory and an accredited central pathology laboratory. Wellquest was established in 2000 by Nicholas Piramal and has conducted about 100 pivotal trials and 40 pilot studies. Both facilities are complaint with Good Clinical Practice and Good Laboratory Practice guidelines.