Clinical Quality Systems address compliance in its entirety: from protocol development to site management and GCP audits, and clinical study reports. In essence, the stronger your Clinical Quality System, the more likely your study will be compliant and able to progress to the next submission phase expeditiously.
MakroCare provides quality system design and completely independent GCP audits of each of your trial sites and vendors. We can provide comprehensive services tailored to your unique needs, to include:
We will work with you to identify the appropriate auditor based on your organizational qualification requirements and needs, ensure the auditor is trained on the audit plan, and then conduct an on-site GCP audit of your clinical site, vendor, and quality system, etc. Following an extensive QC review of the audit report, we will provide you with a final GCP audit report.
Let's talk about how MakroCare can help you
Please leave this field empty.