Ratings from a new CenterWatch survey show that for the third consecutive year 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. In this survey of sites around the world, the most important survey CenterWatch has done measuring the relationship between CROs and sites, three global CROs came out on top: PPD, Kendle and ICON. PPD dominated the results, being rated...
Step-up in FDA audits has sites scrambling to be ready
Investigative sites used to rely on a monitor to ensure the site was compliant with all regulations. If the monitor 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. Regulatory agencies, seeing increasing levels of noncompliance and fraud, are responding by ramping up scrutiny of sites. With increasingly complex protocols, sites must be responsible for their own quality assurance and keep themselves always audit-ready. And the trend toward more FDA audits, as with many industry trends, can mean...
Eye On Human Genome Sciences
The stated mission of 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 on drug discovery and then moved into commercialization and marketing. Well-known examples of HGS’ innovative products include Benlysta (belimumab), which in March became the first new approved drug for lupus in...
To read the full articles for this issue of The CenterWatch Monthly, please click here for subscription information.
