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BizReport : White Papers : Biotechnology & Pharmaceuticals

How Quality and Compliance Can Help Reduce the Cost and Time Involved in Executing Clinical Trials

This white paper discusses the following common quality issues in clinical research as gleaned from FDA warning letters:

  • Deviations from Clinical Trial Protocol
  • Failure to Implement CAPA and Adhere to GCP Standards
  • Inadequate Recordkeeping and Ineffective Management of Essential Documents
  • Lack of Training on SOPs and Other Procedures

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