Trial seekers use specific keywords in searches; FDA proposes conditions for PRO instruments;

> People searching for health information related to clinical research studies tend to use longer and more specific keywords in their Internet searches. Study

> Draft guidance from the FDA instructs that patient-reported outcome instruments can be used as the basis of product approval and labeling claims if: the measure is deemed to be a well-defined and reliable  assessment of the study objectives, the findings are supported by appropriately designed investigations, AND the instrument measures the concept represented by the claim [italics and capitalizations are FDA's]. Draft guidance

> California is asking hospitals to report any serious adverse events from the last several years or swear that none have occurred. Article

> SciQuest is growing and has expanded and extended the lease on its Cary, NC, headquarters. Article

> Business consultancy Huron has acquired Click Commerce and now offers software and services for managing basic research and clinical trials. Huron release

> Attendees at the ClearTrial annual user group meeting in Cambridge, MA, got a sneak preview of ClearTrial v4, the next major release. ClearTrial release

> Cato Research will implement BioClinica's clinical trial management system platform. Cato release

> The SEC has charged a clinical trial investigator with unlawfully tipping a hedge fund portfolio manager about problems with drug candidate. Article

> The National Quality Forum has endorsed a framework for the public reporting of patient safety events. NQF release

> Rensselaer Polytechnic has opened the Center for Modeling, Simulation, and Imaging in Medicine. RPI release

BD&L Summit

Deal-Making Insights for the Life Sciences Industry

Bringing together key deal-makers and serving as an open forum for cross-functional business development and legal teams to share valuable insights and actionable strategies on successfully managing alliances, licensing agreements, and M&A deals.