We can assist you with all aspects of your clinical trial compliance
Our clinical evaluation team is ready to assist. In addition to site GCP audits, we also provide sponsor audits and other vendor qualification reviews.
Global GCP assessments include:
- FDA inspection readiness and FDA mock audits
- Pre-IND meeting and documentation support
- CMC report development
- Trial-master files review
- Clinical operations SOP development and review
- Clinical trial protocol review
- Medical Writing for NDA/ANDA submissions
Clinical Quality & Compliance Services
Our GCP consultants help clients meet quality standards at every stage of development, and avoid costly mistakes.