CLINICAL (GCP) AND BIORESEARCH (BIMO) AUDITING SERVICES

• Compliance with FDA and ISO Good Clinical Practices (“GCP”)

• 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

OTHER CLINICAL COMPLIANCE/SUPPORT SERVICES

• 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

• Technical/medical/regulatory review of protocols and CRFs, pre-BIMO inspections, clinical monitoring, auditing/coordinating CROs, etc.

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Our Clinical Division is staffed by PharmDs, PhDs and medical and regulatory professionals with extensive practical experience in industry and academia, and is an auditing, design review and Quality Assurance resource. However, while AccuReg is not a CRO or SMO, we also can provide a limited number of highly experienced clinical monitors to assist in the conduct and monitoring of clinical trials. Call, email or reach out through social media for a confidential discussion of how our team can best support yours.