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
- Vendor qualification
Audits
- Conduction of system and site specific audits, for-cause audits (incl. preparation, follow-up and CAPA creation)
- Preparation and follow-up of inspections, site and system audits (inspection readiness, CAPA handling)
Project Management
- Project Management of national and international clinical trials with medical products and medical devices
- 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
- CRA training and support in the Monitoring field
- 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
Need assistance to get things done?
Founders
Background
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
- 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
We are looking forward to supporting your project!
