Niamh McGuinness is an expert in clinical trial document submissions and a technical lead with Privacy Analytics’ Clinical Trial Transparency (CTT) business unit. Her team works with a variety of clinical trial sponsors that have turned to us to meet the stringent requirements of regulations such as EMA Policy 0070, Health Canada Public Release of Clinical Information (PRCI), and, more recently, EU CTR. Drawing on her academic research background, Niamh has helped develop Privacy Analytics’ CTT methodology and proprietary toolsets.
In fact, Niamh was one of the first hires for our CTT practice, at a time when Policy 0070 had just come into full effect. She describes that period as a “baptism of fire” for both trial sponsors and service providers like Privacy Analytics.