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The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) is launching an internet search portal this fall that will provide a centralized location to access clinical trial registries and databases worldwide.
Risk management should begin early in a drug’s life cycle and continue for the entire life of the product, according to a Pfizer executive who said strong communication with regulatory agencies and the medical community is necessary to promote drug safety.
Academic institutional review boards (IRBs) in the U.S. are spending the majority of their funding and time on administrative tasks rather than on protocol review, according to a new study.
A computer simulation of a nonobese diabetic mouse could help researchers better understand Type 1 diabetes, and develop treatment and prevention therapies, the virtual mouse’s developers said.
An FDA draft guidance that proposes manufacturers conduct nonclinical safety studies on drug combinations, including adjunctive therapies, is excessive and needs to be further clarified, PhRMA said in recent comments submitted to the agency.
Drugmakers are conducting significantly fewer clinical trials then they were in the 1990s, a trend reflected by a rapid decline in the number of principal investigators (PIs) in the U.S. between 2001 and 2003, according to a new study.
Many clinical investigators have not had proper training and are rarely credentialed by an accreditation organization, according to clinical trials experts, many of whom are concerned about the quality of future clinical studies and the integrity of those who will oversee them.
Roche has launched a public clinical trials registry and results database, the company announced April 15. Thomson CenterWatch, a Boston data management company, is hosting the site for Roche, which is based in Basel, Switzerland.
The FDA may start taking a closer look at the use of electronic patient diaries and electronic data capture in clinical trials from a compliance standpoint, an industry expert predicted recently.
The widespread use of electronic data capture (EDC) technology is helping Novartis Pharmaceuticals cut down on errors during the clinical trial process and achieve research savings approaching $100 million annually.