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...
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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?...
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...
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...
Data Integrity – How To Implement An Effective Audit Trail
Maintaining an audit trail is a regulatory compliance requirement, but what makes a good audit trail that is effective and...