inVentiv Health Clinical recently invested in Mytrus, a California based “Virtual Trial” company. Mytrus has previously parted with Pfizer to create REMOTE, an “at home” clinical study of the bladder control drug, Detrol LA. Although the Pfizer study failed to meet...
In 2012, an all-time high of 28,000 principal investigators participated in FDA regulated research, according to a study in the March/April Tufts Center for the Study of Drug Development (CSDD) Impact Report. However, compound annual growth in the number of active...
A recent study, “Oncology Clinical Trials: Drug Development and Case Studies” examined the average number of patients per site during different phases of oncology trials. The study found that Phase 1 trials averaged 12.9 patients per site, while Phase 2 and Phase...
The continuing resolution (CR) bill provides the FDA with an increase of $24 million is the 2013 fiscal year, according to a recent article on outsourcing-pharma.com. The proposed $2.5 billion FDA budget includes $10 million that would allow FDA to add 16 inspectors...
At the end of February, FDA released a final rule, entitled “Additional Safeguards for Children in Clinical Investigations of Food and Drug Administrated-Regulated Products.” The final rule says that FDA will not allow waivers of parental or guardian permission for...
