QMS for Clinical Trials - Regulatory Compliance and Highest Data Quality
Clinical trials are subject to stringent regulatory requirements. An effective Quality Management System (QMS) in accordance with Good Clinical Practice (GCP) and ISO 14155 ensures patient safety, data integrity and compliance with national and international regulations.
Develop, implement and optimise a bespoke QMS for your clinical trials with our experts.
These include:
- Creation of standard operating procedures (SOPs)
- Risk management in accordance with ISO 14971
- Training for study staff
- Audit and CAPA management
- Preparation for regulatory inspections
With our help, you can ensure that your clinical trials are conducted efficiently, compliantly and to a high standard – for smooth approval and market acceptance of your products.
Structured, compliant, successful – your partner for QMS in clinical trials.
QMS for Clinical Trials - Regulatory Compliance and Highest Data Quality
Clinical trials are subject to stringent regulatory requirements. An effective Quality Management System (QMS) in accordance with Good Clinical Practice (GCP) and ISO 14155 ensures patient safety, data integrity and compliance with national and international regulations.
Develop, implement and optimise a bespoke QMS for your clinical trials with our experts.
These include:
- Creation of standard operating procedures (SOPs)
- Risk management in accordance with ISO 14971
- Training for study staff
- Audit and CAPA management
- Preparation for regulatory inspections
With our help, you can ensure that your clinical trials are conducted efficiently, compliantly and to a high standard – for smooth approval and market acceptance of your products.
Structured, compliant, successful – your partner for QMS in clinical trials.