Increased use of adaptive clinical trials and biomarkers will benefit smaller laboratory services companies, according to Pacific Biometrics (PBI) that turned its operating income from loss to profit in fiscal 2009.
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.