My Activities

General introduction to my services and an overview of possible training topics. Please contact me directly if you have a specific question or want to book a training.  

Training

Training courses can be adapted to teh level of the audience and can be hosted in the facility of your choice.

  • ICH-GCP
  • ICH-GCP Refresher
  • ISO 14155
  • Monitoring for Junior Clinical Research Associates (CRAs)
  • Monitoring for Experienced Clinical Research Associates (CRAs)
  • Clinical Project Management
  • Clinical Research Training for Trial Assistants
  • Clinical Research Training for Site Staff
  • Clinical Research Training for Investigators
  • European Legislation for Pharmaceutical Trials
  • European Legislation for Medical Device Trials

Rescue Monitoring

Are you facing major challenges is your trial? Do you want an expert to guide you? I am more than happy to strengthen you the team and suggest pragmatic, yet compliant solutions.

  • Project Management / Monitoring
  • Current trials going wrong
  • Sites that need alignment
  • International activity
  • CRA coaching
  • Co-monitoring
  • Extra need for a CRA

GCP Compliance Checks

Not sure if what you are doing is compliant to ICH-GCP or ISO14155? Let me do a thorough check and take away your uncertainty.

  • Review of current activities
  • See if trials are in line with ICH-GCP or ISO 14155
  • Mock audit
  • Inspection readiness
  • Full transparency

Consultancy

I can give valuable feedback on how to set up training and training procedures. I can advice you on how you could manage and lead your team or I can help you with GCP related issues.

  • Study Management
  • Advice on ICH-GCP, ISO 14155 or EU Law
  • Solving Team Management issues
  • Advice on Training and Training Plans
  • Implementation of Training Procedures

Team Management

Do you need more in depth knowledge on the preferences of your colleagues, do you want to develop your interpersonal skills or do you want to set up a team building event?

  • Training and Coaching on Time Management
  • Train the Trainer
  • General Communication Skills
  • Use of Meyers Briggs Type Indicator (MBTI) in:
    • Individual Preference Understanding
    • Change Management
    • Team Management
    • Communication Management
    • Conflict Management
  • Team building activities