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Considerations for Using a Mobile Medical App as an Investigational Device

The authors concluded that its secondary analysis of existing data from Study 329 demonstrated clinically significant increases in harms, including suicidal ideation and behavior (SIB) and other serious adverse events in individuals taking paroxetine.

Amid the push for clinical trials to adopt more modern digital data technologies, the job of assuring adherence to key data quality and integrity principles is achievable under current regulations governing electronic record-keeping. Doing so, however, will require a new and reinvented framework: data stewardship.

Washington correspondent Jill Wechsler reports on Janet Woodcock's explanation to Congress last week on the FDA’s lengthy and deliberative process for issuing important policy advisories on biosimilar naming, labeling and interchangeability.

IBM and ICON plc recently announced a collaboration to use the Watson system to enhance oncology clinical trial feasibility, recruitment and start up via Trial Matching.

Synowledge specializes in pharmacovigilance, regulatory affairs and information technology services to support biopharmaceutical companies with recording, analyzing and reporting adverse drug events.

The recent landmark international trial that was conducted at 23 cancer centers around the world including Memorial Sloan Kettering Cancer Center, New York, had results published last month.

The new results, published by The BMJ, contradict the original research findings that portrayed paroxetine as an effective and safe treatment for children and adolescents with major depression.

Much of the growth that has taken place in the top tier of CROs in recent years has been in the acquisition of some of the smaller, more innovative companies, rather than an increase in the number of compounds under study.

An analysis of 10.2 million adverse report records filed with the FDA along with survey of 123 health professionals by Tufts CSDD, found voluntary adverse drug event (ADE) reporting in the United States is incomplete, inaccurate, and inefficient.

New faces among the Pharma Industry rise the ranks.

ICON announced that it is applying IBM's Watson Clinical Trial Matching to its breast, lung, colon and rectal cancer trials.