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PCCTC will utilize its services for the review of its cancer research protocols and related study documents.

Features of the Centralized Data Surveillance include: • Assessing protocol risks, needs and key performance metrics such as site proficiency, calibration, rest between maneuvers, protocol adherence, acceptable/unacceptable Best Test Review data errors impacting the start of tests, and amount of data with repeatability issues

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.

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.

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.

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.

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