Kendle acquired Decision Line Clinical. It’s a boutique Canadian Phase I CRO. Co-founders Edward Sellers and Myroslava Romach will join Kendle. “The company operates an 82-bed, 36,000-square-foot-facility for drug studies in Toronto, and has 110 full-time and 130 part-time employees,” according to this story.
The CSS Informatics division of PPD released a new version of eLoader. The software lets sponsors put patient response, vendor and laboratory data, and trial protocol information and electronic data capture system data from external sources into the Oracle Clinic data management system and the related terminology program, Oracle Thesaurus Management System. Users have the flexibility to load text, SAS transport or Clinical Data Interchange Standards Consortium (CDISC) operational data model (ODM) files or data directly from Oracle tables and views. Here’s the release.
Clinsys Clinical Research, a contract research organization (CRO), joined the CRO program of Medidata Solutions. “Having more data collection choices enables us to deliver customized projects that meet our customers’ objectives, and we know that clients prefer custom solutions rather than a ‘one type fits all’ approach,” said Ferrell Drewry, CIO and VP of biometrics at Clinsys. Here’s the news release.
Jim Clark, the CFO of the clinical trial technology suite etrials, has resigned. The company named its corporate controller and VP of finance, Jay Trepanier, to the interim posts of secretary and chief financial officer. Here’s a story and a release.
ClinPhone received its good clinical practice (GCP) inspection certificate from the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK. Steve Kent, CEO, ClinPhone, said: “This reinforces to our clients that ClinPhone is fully committed to good clinical practice. We have the appropriate policies and procedures in place, as well as robust technology with sufficient back-up systems, to successfully manage our clients’ studies to the very highest standards.” Here’s the release.
The FDA continues to face brutal criticism from politicians. One congressperson wants to give the FDA the power of subpoena. Another, Rep. John Dingell, recently exploded at FDA head Andrew von Eschenbach. Said Dingell: “You can’t do your job. You know I’ve been in this business a long time and I’ve had FDA commissioners constantly tell me ‘Oh, we are going to have a new means of doing this, and we are going to be leaner and meaner.’ It turns out that they are leaner and poorer and weaker and less capable of doing their job. And all these promises that I get from FDA commissioners about how they are going to do better turn out to be nothing more or less than, quite frankly, phooey.” Here’s the article in Medical Marketing & Media.
This $4,000 report from Global Industry Analysts has information about the market and science in the contraceptives therapeutic area.
The CRO market is recession-proof. That’s the thinking on Wall Street, according to the Associated Press. Charles River estimates that perhaps a quarter of research is outsourced now, and that figure could double. Goldman Sachs estimates a 7 percent annual rise in industry research spending. “We haven’t, to date, seen any major cutbacks in research area funding,” said Terri Cooper, a life sciences consultant with Deloitte Consulting: “They [pharma companies] recognize that somehow they’ve got to fuel their research and development pipelines.” Here’s the AP story.
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