Audit-Ready Studies
Reduce risks of delays and findings through proactive QA oversight.
Our QA head, Betty Song, is a former executive at multinational companies and global CROs, bringing extensive global experience and strategic oversight.
From routine QA activities and study document reviews to external audits, CAPA follow-up, and training, we deliver a complete spectrum of QA solutions.
We provide objective third-party auditing services, ensuring unbiased assessments of trial processes and vendor compliance.
We combine international regulatory knowledge with deep operational expertise in China, ensuring high-quality, cost-efficient support.
Routine QA support and consultancy
Review and finalization of key study documents
Daily communication and participation in project meetings
Study issue discussions and CAPA planning
Review of responses to external audit reports
Regular quality review meetings
Audit Services:
1. Audit plan design
2. On-site and remote audits
3. CAPA plan review and follow-up
4. Audit observation sharing and staff training
Reduce risks of delays and findings through proactive QA oversight.
Leverage insights from seasoned professionals who have supported global inspections.
Identify and resolve quality issues early, minimizing costly rework or regulatory setbacks.
Ensure your studies meet ICH GCP, FDA, EMA, and NMPA requirements.
GCP ClinPlus delivers exceptional expertise with genuine commitment to our projects. Their team demonstrates remarkable responsibility at every stage, consistently going above and beyond. In an industry where dedication matters, they've proven themselves an invaluable partner for our success.
After enrollment challenges with our previous CRO threatened our study timeline, GCP ClinPlus stepped in and transformed our project. Their team rapidly accelerated patient recruitment beyond our expectations and put our critical study back on track. Their clinical expertise and swift implementation proved decisive in securing our study's success.
GCP ClinPlus stands out for their exceptional responsiveness and customer focus. Their team consistently prioritizes our needs with prompt, thoughtful solutions to every challenge. Their combination of technical excellence and client-centered approach makes them a truly strategic partner in our development programs.
