GCP and ISO 14155 Compliance Consulting for Medical Device Clinical Studies
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical studies carried out in human subjects. It also serves to protect the rights, integrity, and confidentiality of study subjects. Compliance with this standard and ISO 14155 provides public assurance that the rights, safety, and wellbeing of study subjects are protected and that clinical data are credible.
Failure to address GCP / ISO 14155 compliance concerns from the beginning often results in delays in approval due to improperly designed studies, omitted studies, missing oversights and other failures to meet key regulatory requirements.
GCP compliance check should be performed:
At the Sponsor/CRO:
- Standard Operating Procedures (SOPs)
- study documents – e.g., review of clinical investigational plan (CIP)
- processes – e.g., review for adherence to SOPs and regulation
- systems - oversight, quality assurance (e.g., CAPA system)
At the study site:
- study documents – e.g., completeness check of investigator site file (ISF)
- processes – e.g., procedure for obtaining consent Form (ICF)
- qualification and performance
Emergo's CRO team in Germany has expertise in GCP and ISO 14155 compliance
Our medical device clinical professionals can conduct a GCP compliance check as described above and provide corrective action recommendations for your clinical study. Here is how we can help:
- Ethics Committee and Regulatory Authority submission documents review
- Clinical Investigation Report review
- Trial Master File review
Please contact us to learn how we can help you ensure your clinical study complies with GCP and ISO 14155.