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Dante Resources is a clinical research organization specializing in regulatory submissions with deep expertise in phase III clinical trial data preparation and submission. The Dante Resources blog content is drawn from Dante Resources over 20 years of successful CTD, eCTD regulatory submissions without a single refusal to file.
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2009
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October
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- Quality Data Management at Clinical Study Sites
- No title
- Quality Control of Data, Data Review and Discrepan...
- Stability/Clinical Studies - 505(b)(2) - Rate-Limi...
- 505(b)(2) CMC Role in Clinical Submission
- 505(b)(2), Importance of a Bridging Study
- More About Understanding 505(b)(2)
- Understanding 505(b)(2) and Why
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October
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A question to Dante's pharma, biotech and device readers rather than a comment - Who creates your Data Quality Control, Data Review and Discrepancy Management SOPs and WIs? In your respective company, are these SOPs and WIs created and written internally, inhouse or are they written by consultants and/or CROs?
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