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February 26, 2020

Why You Should Be Qualified to Conduct Clinical Trials as per ICH GCP

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
GCP Renovation

ICH GCP Renovation. The way forward

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

Advanced Therapy Investigational Medicinal Product (ATIMP) Trials

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, […]
January 4, 2019

Development Goals. The Right Way to Keep Your Team Engaged!

How many articles or blog posts have you read lately regarding leadership, how to keep company’s employees happy and engaged? I can tell you that I have read loads and some of them are extremely good. You can see in social media how many likes they get and the hundred […]
December 11, 2018

Safety reporting to investigators (SUSARs): Mistakes you will never make again

All adverse drug reactions (ADRs) that are both serious and unexpected (Suspected Unexpected Serious Adverse Reactions, SUSARs) are subject to expedited reporting. Since the main objective of pharmacovigilance is the identification of information that may affect the safety of patients, once a potential risk is noted, it must be communicated […]
September 26, 2018

How to Assess an Electronic Health Records (EHR) System for Clinical Research

Whether paper or eSource, investigators and sponsors need to ensure that there are adequate controls in place to preserve the confidentiality, integrity, and security of data. Electronic Health Records (EHR) systems need to be assessed by the Sponsor and/or CRO for compliance with regulatory requirements before investigator sites activation, but […]
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