Latest News
March 20, 2020
This article pretends to follow-up a previous publication we did covering the initial guidance that was provided by some of the European National Competent Authorities (NCA) with regards to the COVID-19 outbreak. Since the situation keeps evolving, almost every day we have been notified by different media that another Competent […]
March 16, 2020
The COVID-19 dissemination is highly impacting the lives of all of us, personally and professionally and we still do not know how this situation will progress and when we could go back to normality. Working on clinical research, we need to keep on working to safeguard first the safety and […]
March 11, 2020
Delegation of responsibilities related to a clinical trial is an area that is not always properly understood by the investigators. Incidents with the completion and maintenance of the Delegation Log are repeated over and over across all the research sites which suggest that the investigators did not receive appropriate training. […]
February 26, 2020
As GCP auditors we keep on facing the same GCP non-compliances when conducting investigator site audits and hosting regulatory inspections due to the sites staff, and also clinical operations personnel overseeing sites, lack of understanding of the seriousness of the procedures they must follow and the impact of their actions […]
November 12, 2019
ICH E8 and E6 need modernizing to prepare for the future, a future that will bring future medicines, future trial designs and future data sources [1]. This is the so called ICH GCP Renovation project. On the 12th of January 2017, following the adoption of the integrated addendum update to […]
April 22, 2019
On Friday 12th April 2019, I had the opportunity to attend a seminar on good cellular therapy practices organized by the Spanish Ministry of Health and the Spanish Competent Authority, Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) representing our consulting firm, Pharmity. Speakers from the Ministry of Health, AEMPS, […]