Scientists have written to the Prime Minister and Health Secretary Andrew Lansley expressing their concern about drug failures and adverse drug reactions.

The letter stated that more than 10,000 people die every year from bad reactions to prescribed treatments. Scientists are now calling for a fresh approach.

All clinical trials require systems to be in place to ensure that all Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) are reported in accordance with the regulations and relevant guidelines.

Pharmaceutical companies need to deal with a ton of paperwork, as reporting of adverse events during clinical trials is required by law. Compliance is also a hard requirement to enforce and needs to be verified by a combination of internal auditing and regulatory authority inspections.

Casewise’s SUSAR module is an automated review and approval workflow process 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-based, wizard-based workflow process automated though the process approvers, documented and monitored, providing a complete audit trail.

It reduces potential human errors, enables decision transparency, ensures tasks are completed on time, and enforces regulation, compliance and policy governance.

The solution ensures that all relevant information about a Suspected Unexpected Serious Adverse Reaction (SUSAR) which occurs during the course of a clinical trial is submitted to the appropriate regulatory authorities within the required time frames.

For more information about the SUSAR solution, please contact Casewise today.