ABR’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 both industry and academia, providing an optimal balance between research and commercial needs.

Our clinical services include:

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• Project Management

• IND and IDE Preparation, Compilation, Submission, and Maintenance

• 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

• Clinical site monitoring

• Quality Assurance: Clinical Site Audits, Database Audits, Site Qualification/Audits, Vendor Audits,  GLP and GMP Audits, For-Cause Audits, Pre-Approval Inspection Audits

• Training for Good Clinical Practice