Latest News
January 4, 2019
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
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
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 […]
August 27, 2018
Maintaining an audit trail is a regulatory compliance requirement, but what makes a good audit trail that is effective and complies with regulations? This article will explain what and audit trail is, what the applicable regulations are and the main aspects to consider when implementing an audit trail to contribute […]