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
  • Vendor qualification

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 the national and international environment
  • 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)
  • Inspection readiness

Training

  • Design according to your specific training needs (whether SOP development  / update or all sections for conducting a clinical trial etc.)
  • Starting from one person
  • Flexible time according to your requirements
  • Implementation of the training within 10 days after request
  • Comprehensive training documentation

Ethics and Regulatory

  • Submission of national mono and multi-center clinical trials within the framework of the requirements of AMG and MPDG (IMP and MD)
  • Network of freelance partners and CROs to carry out international submissions

Founders

Background

Uta Brunner

Uta Brunner

  • 30 years of experience as Project Manager / Central Project Manager  / Qualit Manager  / GCP-Auditor and Senior CRA in clinical development
  • Deputy Team Lead Monitoring
  • More than 100 studies in different indications
  • Development of departments clinical development and monitoring
  • Trainer in the area of clinical trials
Mirko Memmhardt

Mirko Memmhardt

  • 16 years of experience as Project Manager / Central Project Manager  / Quality Manager  / GCP-Auditor and Senior CRA in clinical development
  • Deputy Team Lead Project Management
  • More than 30 studies in different indications
  • Development of department clinical development
  • Trainer in the area of clinical trials

Partners

Cooperation