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GOOD MANUFACTURING PRACTICES SERVICES

To ensure that scientific and ethical standards are met in the conduct of clinical trials, the experienced clinical scientists of BioResearch Monitors, Inc. use proprietary computer based audit tools customized to each protocol, to collect, analyze and report quality assurance audit findings. This is a systems oriented approach to data quality assurance, driven by the study protocol, that addresses and seeks to validate the assumptions, technical requirements and documentation inherent to the study's scientific rationale and regulatory acceptability. Integral with this approach is an evaluation of the activities undertaken, and documentation generated, in support of general ethical and regulatory GCP requirements.

BioResearch Monitors, Inc. performs GMP evaluations of Sponsor and Contract Clinical Supply operations including:

  • QA/QC systems evaluations
  • Packaging & labeling
  • Storage and distribution
  • Product complaint investigations
  • GMP required records & reports

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