Dr. Kathrin Mertens

Involved in the controlled distribution of a first-in-class orphan drug, under strict conditions imposed by the EMA, as well as market access activities including pricing & reimbursement submissions.

Main responsibility is the oversight and management of a number of multicentre phase II and III RCTs (radiotherapy and CTIMP), with some international collaborations and pharmacy collaboration.

Responsible for the Quality of Life sub study of a trial with 100 centres and over 1,800 patients, and supporting trial manager with any tasks as required. Use of various trial management systems to oversee follow-up mailings, perform data checking to ensure high quality data collection, and to monitor return and compliance rates.

Responsible for the oversight of musculoskeletal disorder multi centre RCT (over 500 patients), including liaison with study personnel at participating centres and reporting to relevant authorities and stakeholders. Use of database and trial administration systems to coordinate follow-up mailings, and overseeing data acquisition and data quality. Chair of the Epidemiology Procedures Group (SOP development and compliance monitoring).

“Zinc in inflammation and sepsis”: Investigating the effects of zinc deficiency on molecular mechanisms contributing to the pathophysiology of sepsis (in vitro and clinical pilot study).