Executed and Ongoing Projects and Activities

(Excerpt Medical)

Quality Management System

Clinic at a university hospital

  • Design 2017
  • Implementation 2017
  • Training 2017
  • Audits 2018

Medical Registry

National data registry of a Swiss medical society

  • Design (manual, standard operating procedures, agreements, forms); 2013 and 2017
  • Assignment for the auditing of 18 affiliated clinics in Switzerland since 2015
  • System audit 2017

Project Management Global Trial Project

Pharma (USA)
Global Research

  • Project management
  • Project controlling
  • Quality assurance
  • Financial controlling
  • Project communication worldwide
  • Training affiliates

Regulatory Consulting

Pharma (EU)
Regulatory Affairs Switzerland

  • Submission to authorities
  • Swiss Act of Human Research

Quality Management in Research

Hospital (CH)

  • Development of Quality Assurance System
  • Maintaining of Quality System
  • Implementation of Swiss Act of Human Research
  • Training and consulting
  • Development of IT-data report system for patients in clinical research projects
  • Safety trainings

Monitoring Clinical Trials

IIT-Projects Switzerland

  • Preparation of visits
  • Monitoring (initial, routine and close-out)
  • Reporting
  • Support and training research teams

Submission of Clinical Research Projects

(Several) Sponsors Switzerland

  • Consulting
  • Documentation processing
  • Submission
  • Communication to authorities
  • Preparation and organisation of project start including SOP
  • Training of research team

Setup and Management of Clinical Trial Unit of a Clinic

Hospital Switzerland

  • Project administration
  • SOP -Standard Operating Procedures
  • Quality assurance
  • Project management
  • Build-up and lead of research support team
  • Training of research team