Quintiles preps CTMS for commercial sale; stats may sub for trials in personalized medicine;

> CIO Richard Thomas and his IT group are leading the effort to take Quintiles's Infosario CTMS from internal tool to commercial product. Article 

> A statistical strength standard, gleaned by mining federated data pools, may be the answer to the insurmountable mismatch between conventional clinical trials and personalized medicine. Paper

> Simulations Plus will work with the FDA to develop models that determine toxicity levels in food additives and contaminants. Item

> Web-based clinical data surveillance services from Pharmacy OneSource aim to help clinicians identify adverse drug events. Article

> In reviewing VIVUS's NDA for the diet pill Qnexa, the FDA has asked the drug developer to examine whether it can use existing databases to determine the risk of oral cleft in children whose mothers took topiramate, a Qnexa ingredient, to prevent migraines. Article

> An HHS report says that NIH lacks information on conflicts of interest among grantee institutions. Story

> Citigroup analysts began watching shares of eResearch Technology last week, issuing a "hold" rating. Item

> Blood component and tissue provider Hema-Quebec has selected Pilgrim to manage quality-related processes, including document management. Story

Suggested Articles

There's no evidence personal patient information leaked during the 11-week breach, but the same can't be said about Sangamo's own secrets.

Through a new online tracker, AllTrials names sponsors who fail to report clinical trial results on time per the FDAAA Final Rule.

The new solution aims to streamline the incorporation of human genomic data into clinical trial designs.