The Muenchner Studienzentrum (MSZ) is the central academic research organisation (ARO) for all disciplines at the Medical School of Medicine of the Technical University of Munich (TUM). Together with the Institute for Medical Statistics and Epidemiology (IMSE), TUM, it forms a highly experienced cooperation unit which is dedicated to offer comprehensive clinical research solutions for investigator-initiated trials (IITs) as well as industry- sponsored clinical trials by promoting their quality and efficiency in accordance with national and international guidelines.
The Muenchner Studienzentrum will contribute its services as a CRO for IITs to WP5 (Validation of Mechanisms through Interventions). Tasks of the MSZ comprise project planning (aspects of study design and finances), organisational project management (i.e. development and actualization of study documents including protocol and informed consent, international regulatory affairs, international ethics committees, recruitment supervision, protocol adherence, communication and reporting, sponsors legal responsibilities), data management (i.e. development of electronic case report forms and data base, data quality assurance), safety management (i.e. development of safety data base, processing of serious adverse events, MedDRA-coding of adverse events, annual safety reports to ethics committees and competent authorities) and quality assurance (i.e. monitoring of study data at participating study sites, providing of SOPs).
Dr. Silvia Egert
Dr. Egert (PhD) is project manager especially of large multicenter trials and the head of business development of the MSZ. She has longstanding (>10 year) experience in conducting clinical trials and has been partly responsible for the development of the MSZ. She contributes to project planning and will support project management of the clinical trial.
Dr. Elisabeth André
Project Management, MonitoringDr. André (PhD) is the head of the monitoring unit of the MSZ. She has longstanding experience as a clinical project manager and clinical research associate including international trials and is well-experienced in coordinating, monitoring and managing clinical trials according to international guidelines. Dr. André is member of the KKS-working group "Monitoring" and will coordinate the monitoring of the clinical trial.
Dr. Alfred Zollner
Data and Safety ManagementDr. Alfred Zollner (PhD) is the vice director of the MSZ and the head of the combined data- and safety- management unit. He will be involved in the supervision of both tasks in the clinical trial. Dr. Zollner is member of the KKS-working group "Data Management".