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Clinical Services

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AccuReg’s clinical services focus on identifying and preventing or correcting problems before issues impact the quality, integrity or duration of the study. PharmDs, PhDs and other medical and regulatory professionals staff our clinical division. They possess extensive practical experience in industry and academia.  Note:  AccuReg is not a CRO or SMO, and does perform routine clinical monitoring. Our Clinical division is an auditing, design review and Quality Assurance resource that also supports client regulatory submissions and reporting.

Our clinical auditing services include:
  • Assessments of protocol compliance, including evaluation of subject selection, conformance with inclusion/exclusion criteria, informed consent, concomitant treatment information, post-treatment evaluations, surgical procedures and laboratory assessments
  • Data verification and evaluation for integrity and validity, identification of inconsistencies and anomalies
  • Examination of documentation practices, including CRFs, source records, and test article accountability
  • Identification of study-specific concerns, including adverse event recording and ADR reporting
  • Evaluation of clinical site acceptability
  • Evaluations of IRB conduct and, if applicable, SMO/CRO performance
  • Preparation of Clinical Risk/Benefit Analyses, risk assessment documents, and regulatory reports
Other clinical services include:
  • Protocol development and review
  • Statistical analysis and review
  • Data management process development and review
  • Case Report Form (CRF) development
  • Clinical procedures development
  • Training in procedures and Good Clinical Practices (GCPs)
  • Pre-IND/IDE meetings
  • Preparation of, coaching and participation in Advisory Committee Meeting presentations
  • Investigator Meeting coordination and participation
  • IRB selection and review
  • Clinical site selection and review
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