Compliance Solutions for the Pharmaceutical Industry - Adherence to the SUSAR Regulations & Requirements

All clinical trials require systems to be in place to ensure that all SAEs and SUSARs are reported in accordance with the regulations and relevant guidelines. Reporting of adverse events during clinical trials is required by law. Compliance by the organizations carrying out clinical trials is verified by a combination of internal auditing and regulatory authority inspections. 

Casewise's SUSAR module is an automated review and approval workflow process based around the SUSAR procedure, from initiation to validation, reporting and analysis, monitoring and audit trails, enforcing compliance of internal procedures.

The SUSAR module is a web and wizard-based workflow process. Being fully automated and based around the various process owners, all stages of a clinical trial are documented and monitored and as a result, provide a complete audit trail. This automated solution therefore reduces potential human errors, enables decision transparency, and ensures that tasks are completed on time, therefore enforcing regulation, compliance and policy governance. The solution ensures that all relevant information about a SUSAR which occurs during the course of a clinical trial is submitted to the appropriate regulatory authorities and ethics committees within the required time frames.

For more information about the Casewise SUSAR solution, please contact your Regional Casewise Office