We have experience covering the following areas:
• Study monitoring
• Selection of clinical investigators
• Validation of computerized systems
• Clinical data management systems and data centers
• Drug distribution centers
• Central laboratories
• Pharmacovigilance and safety reporting
• Data management and database
• Interactive Voice Response Services (IVRS) and Interactive Web Response Services (IWRS)
• Central reading services
• Risk Evaluation and Mitigation Strategies (REMS)
• Demonstrate sponsor oversight by qualification of new vendors prior to the start of the study.
• Vendor/CRO audits determine the ability to met regulatory requirements, personnel are qualified and trained and processes are defined and appropriate.
• During a routine vendor audit (post contract award) it was discovered that unqualified employees were involved with the project.
• Contract monitors never elevated clinical investigator site compliance issues to management for timely resolution.