Niamh McGuinness

Niamh McGuinness,

Senior CTT Analyst

Niamh McGuinness is 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 and Health Canada Public Release of Clinical Information (PRCI).

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.

Drawing on her academic research background, Niamh has helped develop Privacy Analytics’ CTT methodology and our proprietary toolsets. These toolsets automate many of the more tedious aspects of anonymization so that she and her team can focus their time on delivering higher value service to clients.

Niamh has personally managed many successful projects, with documents representing more than 100 clinical trials, some all the way to publication on the EMA’s Clinical Data Portal. She also led our first dedicated Health Canada PRCI submission. Under her watch, no client has ever missed a regulatory submission deadline or a deadline to make their trial data publicly available.

Today, Niamh shares her expertise in risk-based anonymization of clinical trial documents by attending and presenting at international conferences and forums. Recently, she took a seat on the industry’s Policy 0070 Working Group. The Working Group includes global pharmaceutical companies and other anonymization service providers.

“No matter what deadlines you face or how complex your documents, we can help,” Niamh says. “My team has the experience and the commitment to see that every project is done right. .”