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With the constantly changing regulatory landscape, Life Sciences companies need to keep up and develop systems and collect data to address the regulatory reporting requirements and standards. Trexin can enable Life Sciences companies in the Safety and Compliance areas as follows:
- Proactively predict or identify potential for non-compliance, helping avoid compliance risk
- Help develop enabling systems in support of standards such as IDMP, and dictionaries such as MedDRA and WHODD.
- Leveraging business intelligence and advanced analytics, support pharmacovigilance and adverse event reporting and analytics
- Dashboard and enhancements of systems to support commercial compliance including aggregate spend (Open Payments) reporting and analytics
- Plan and execute testing and validation as per 21CFR11 standards
Trexin brings its technology strategy, solution delivery, advanced analytics, business intelligence, data management and governance capabilities to help address the key challenges and leverage new opportunities for Life Sciences companies.