May 2011 – The CenterWatch Monthly : PDF
Sites worldwide rate PPD, Kendle, ICON top CROs
Ratings from a new CenterWatch survey show that for the third consecutive year contract research organizations (CROs) have continued to improve their relationships with investigative sites, particularly as CROs focus resources on improving project management and training monitors to make it easier for investigators to conduct successful, more efficient clinical studies.
Step-up in FDA audits has sites scrambling to be ready
Investigative sites used to rely on a monitor—sent by the sponsor or CRO every few weeks to check the study data—to ensure the site was compliant with all regulations.
The monitor was the site’s main contact with the industry, and if she didn’t see any problems in the data, the site felt secure in its readiness for an FDA audit, should one suddenly occur.
Those days are gone…
Eye On Human Genome Sciences
The stated mission of Human Genome Sciences (HGS) is “to apply great science and medicine to bring innovative drugs to patients with unmet medical needs.” This relatively young company began by focusing mostly on drug discovery and then moved into commercialization and marketing of its promising lead products, as well as those in the GlaxoSmithKline (GSK) clinical pipeline. However, HGS has an ongoing commitment to scientific innovation and development of new medicines for life-threatening acute and chronic diseases, using its strengths in the discovery and understanding of human genes and their biological functions.
Also in this issue:
- Stimulating regulatory harmonization of medical devices
- Industry Briefs
- The Pulse on Recruitment
- New Study Launches