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.
Quintiles believes there is a “dire need” for trial sites that can raise standards and reduce inefficiencies in the clinical research process and is expanding its Prime Site programme to meet this demand.
Hyderabad, India-based Makro Care says its GCP “helpdesk” website has already proved to be an invaluable information source for contract research organisations (CRO), investigators and pharma trial sponsors.
Russia-based CRO SynRG has cut the time to prepare a detailed proposal from two weeks to two hours, giving the company a competitive advantage over its rivals, and established a presence in the US to target small to mid-sized companies.