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Scientific : Products : Thomson Pharmaceutical Services: Quality Assurance and Auditing Services
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Thomson Pharmaceutical Service: Quality Assurance and Auditing Services
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We provide cost-effective quality assurance support that can save your company time and money by identifying potential problems early in the drug development process.
Using a variety of auditing tools, we validate the procedures, assumptions, and data that support the regulatory acceptability of your clinical and non-clinical programs. We offer a constructive approach and an informative style allowing for early institution of quality checks and balances.
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Source Document Audits
- QC audits
- Data listing and electronic database audits
- Validation audits comparing CRFs to data listings
- Audits of sponsor central file archives
- Clinical study report audits
Regulatory Submission Audits
- QC of hypertext links, roadmaps, and other components of electronic INDs, NDAs, and CTDs
- QC of all components of print INDs and NDAs
Site Audits
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