38 years of passion for quality and project management!

Services

Project Management and beyond

Quality Management

  • Analysis of quality processes and SOP systems
  • SOP development support
  • Improvement and implementation of updated quality processes
  • Organisation of detailed training based on quality standards

Audits

  • Conduction of system and site specific audits, for-cause audits (incl. preparation, follow-up and CAPA creation)
  • Attendance of system and site specific audits and inspections

Project Management

  • Project Management of national and international clinical trials
  • Budget development and review
  • Management of 3rd party vendors
  • Set up of monitoring teams incl. creation of monitoring plans, training of CRAs and co-monitoring

Monitoring

  • Set up of monitoring teams incl. creation of monitoring plans, training of CRAs and co-monitoring
  • Monitoring services in Phase I to III trials, MPG-studies
  • Ability to cover complex multicenter trials due to longstanding cooperation with a network of freelance monitors

Trial Master File

  • Trial Master File (set up, finalisation and check of completeness)

Ethics and Regulatory

  • Submission of national mono and multi-center Phase I to III trials according to AMG and MPG-studies
  • Network of freelance partners and CROs to carry out international submissions

Founders

Background

Uta Brunner

Uta Brunner

  • More than 25 years of experience as Project Manager / Central Project Manager and Senior CRA in clinical development
  • Deputy Team Lead Monitoring
  • More than 100 studies in different indications
  • Development of departments clinical development and monitoring
Mirko Memmhardt

Mirko Memmhardt

  • 12 years of experience as Project Manager / Central Project Manager and Senior CRA in clinical development
  • Deputy Team Lead Project Management
  • More than 30 studies in different indications
  • Development of department clinical development

Partners

Cooperation