Blog
Technical issues lead to a delay of EU Clinical Trial Regulation application
The application of the clinical trial regulations has been postponed due to technical issues of the IT systems. Because of this, the EU Clinical Trial Regulation will not go into effect until 2019. The ultimate goal of the new system is to provide a single-entry port...
Pearl IRB proudly announces the completion of a clean FDA audit
Pearl IRB proudly announces the completion of a clean FDA audit. There were no significant findings during the May 2017 audit and FDA issued no 483s. Our AAHRPP accredited IRB operates in compliance with all federal and state regulations governing clinical research....
Updated clinical trial common protocol templates aim to speed up research, align objectives & endpoints
The NIH-FDA Joint Leadership Council and TransCelerate BioPharma released updated common protocol templates (CPT) last week to accelerate clinical development. An Outsourcing-Pharma.com article and interview with TransCelerate CEO, Dalvir Gill, details some of the key...
Experienced clinical research associate joins Pearl IRB
Pearl IRB is pleased to announce the hiring of Masheka Fuqua as a Clinical Research Associate (CRA) serving biopharmaceutical, medical device, and diagnostics companies. Fuqua brings over a decade of clinical research experience to Pearl Pathways, including the...
China FDA mimics US clinical trial application process to accelerate drug approvals
China’s Food and Drug Administration (CFDA) set a goal to push drugs to clinics faster. How will they accomplish this goal? Recent policy proposals suggest CFDA are looking at the US Food and Drug Administration (FDA) for answers. Imitation is the greatest form of...