Clinical research is critical to development and registration of new medicinal products. We are here to help you maintain ethical and regulatory standards in compliance with ICH E6(R2), ICH E8, EMA, FDA and MHRA when conducting Clinical Trials with Investigational Medicinal Products (CTIMPs). We can also cover the specific requirements for Advanced Therapy Investigational Medicinal Products (ATMPs/ATIMPs), for example Gene Therapy.
We offer Training in Clinical Research:
Do you need to tick the Clinical Research training box, and keep your staff happy at the same time?
Do you need to refocus or reinvigorate your Clinical Research training?
We can help!
We can:
- Design and deliver training for you, either in the classroom or online.
- Help your trainers develop and deliver their own material.
- Review and validate your existing training material.
Visit our Bespoke Clinical Research Training page to see the subject areas we can cover in
the classroom or online, or take a look at our Online Training resources and Live Webinars.
We also offer GCP Compliance Consultancy:
We can help you with your Quality Management System and SOP review and preparation.
- Inspection readiness
- SOP review and update
- GCP advice
Visit our Consultancy page for more information.
Contact us by completing the contact form or by e-mail using jo@joburmester.com
Check out my YouTube channel here!