Safety Management Systems (SMS) are designed to systematically manage adverse event reporting, risk assessment, and pharmacovigilance activities. By implementing robust SMS, organizations can proactively identify, assess, and mitigate risks associated with their products, ensuring patient well-being and adherence to global safety standards.
Stay aligned with global regulatory requirements through automated reporting and documentation.
Identify potential safety issues early, reducing the likelihood of costly recalls or legal challenges.
Streamline safety processes, reducing administrative burdens and allowing teams to focus on critical tasks.
Ensure accurate and consistent safety data collection, analysis, and reporting.
A modern Individual Case Safety Report (ICSR) management system that handles the intake, processing, and submission of adverse events for both clinical and post-marketed products. Veeva Safety provides global oversight and streamlines case management, ensuring compliance with evolving regulatory requirements.
An innovative enterprise workspace designed specifically for life sciences, offering a unified approach to managing business-critical content and information. CARA enables rapid, codeless implementation of regulated business processes, ensuring seamless management of safety data across the organization.
A leading provider of Regulatory Information Management (RIM) solutions, EXTEDO offers comprehensive tools for managing regulated documents, data, and processes. Their solutions ensure compliance with international standards, streamlining safety data management and reporting.
eLife Sciences is a team of experts with unique experience in compliance, validation and quality assurance (QA). We provide services to companies in regulated industries with a special focus on life science.
