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Institutional barriers to electronic data capture (EDC) are falling away as the pharmaceutical industry is increasingly coming to recognize the benefits of retiring paper trials forever.
Cyber-Ark's secure virtual vault data technology is helping AstraZeneca upgrade its clinical trial and information-sharing functions, according to project team members who spoke to PIR recently.
The high-profile natural and man-made disasters of the past few years, from 9/11 to Hurricane Katrina, have underscored the need for businesses of all sorts to protect their critical data.
California lawmakers will consider legislation this spring that would require pharmaceutical firms to disclose the results of all clinical trials done on each drug sold in the state.
The FDA has released a series of guidances and a final rule aimed at speeding products to market by streamlining the investigational new drug (IND) application process.
The FDA’s latest bid to accelerate new drug approvals, while praised by the pharmaceutical industry, is facing a backlash from some lawmakers and advocacy groups who point to the proposal as evidence the agency is too close to industry and does not place enough emphasis on public safety.
Clinical investigators can begin to test microdoses of new investigational drugs in smaller numbers of people before beginning conventional Phase I clinical trials, according to new FDA guidances that could change the face of clinical trials.
Medical journal editors are cracking down on authors who fail to disclose ties to drug or device companies, following several journal disclosures that peer-reviewed articles were written by freelance writers hired by drug companies.
Johnson & Johnson’s (J&J) embattled heart-failure medication Natrecor is again under fire after the company revealed this week that it failed to inform federal regulators about the deaths of two patients who participated in a clinical trial of the drug.