Clinical research is critical to development and registration of new medicinal products and medical devices. 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) or Clinical Investigations with Medical Devices (ISO14155). 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!
- 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.
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.
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