Comprehensive and High-Coverage Third-Party Auditing Services
SDM provides high-quality third-party auditing services to clinical trial sponsors and research centers, aiming to be the most professional and efficient provider of clinical trial auditing services. We follow the GCP Quality Management Regulations and conduct systematic, independent audits of clinical trial activities and documentation to assess whether the implementation of clinical trial activities, as well as the recording, analysis, and reporting of trial data, comply with the trial protocol, SOPs and relevant laws and regulations.
• In-house expertise and experienced and skilled auditorors with deep knowledge and wide-ranging experience in clinical trials
• Quick response and high work efficiency
• Domestic and international
Coverage of Clinical Trials and Research Areas. We offer auditing services for clinical trials covering all modalities and therapeutic areas. We have developed a highly professional and efficient third-party auditing service system.
On-Site Research Center Audits
- Routine audits For course audits
Vendor Audits
- Audits of bioanalytical laboratories Audits of investigational drug manufacturers
Verification-related Audits
- Pre-audit self-inspection Inspection readiness training
Experienced and Skilled Auditor Team
- Team: SDM auditors have years of GCP experience and years of quality experience in clinical research with a deep understanding of and proficiency in auditing process.
Quality: 100% audit coverage of key data/documents, with immediate communication of important findings to enable timely risk control and problem resolution.
Integrity: Cognizant of risk control and confidentiality.
Are You Facing Any of These Challenges in Clinical Trials?
How can you identify and assess quality risks at site level?
Are there any issues with the timing, quantity or logical consistency of trial records?
Are there data errors in critical safety or efficacy?
How should self-inspection and inspection readiness be conducted?
How can you supervise and manage vendors such as CROs, SMOs, labs testing, and cold chain providers?
It's easy to talk to one of our experts. Get in touch with your questions or comments and a member of our team will get back to you directly.
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