The GAO sting operation and subsequent increased scrutiny will “definitely change how pharma and CROs choose IRBs”, according to the VP of NEIRB who spoke to Outsourcing-Pharma after successfully completing a FDA audit.
The FDA is hoping to increase the likelihood of a clinical trial being successful by making best use of science and alternative study designs and has issued end-of-Phase IIa (EOP2A) meeting guidance to explain the process.
IT provider DZS Software Solutions’ says its ClinPlus CTMS system has been selected to manage an upcoming trial of PhotoThera’s transcranial laser technology in patients who have suffered acute ischemic stroke.
QPS’ bioanalytical laboratory in Taiwan is the first in the country to be certified as compliant with good laboratory practice (GLP) standards by the Department of health (DoH), according to unit president Vincent Yen.
Perceptive Informatics (PI) has added Optasia’ KneeAnalyzer to its clinical offering, positioning itself for the anticipated surge in number of trials examining musculoskeletal drugs over the next few years
Virtify says the new online version of its Virtx CTRR system can help drugmakers comply with the increasingly complex disclosure rules that regulators worldwide apply to clinical trials, in an automated approach that saves time and money.