Streamlining AE Management with Automated Solutions
Are you finding it difficult to manage the compliance and workload demands associated with the Canada Vigilance Adverse Reaction Online Database review? If you are navigating the intricate landscape of the Canada Vigilance Adverse Reaction Online Database, you may be facing some of these challenges:
- Frequency: Managing monthly consultations
- Workload: Handling a high volume of Adverse Event (AE) reports
- Timeline: Meeting the 15-day reporting deadline to foreign regulatory authorities
- Resourcing: Limited staff and budget constraints
To address these challenges, Innomar Strategies has developed an innovative automated tool designed to streamline your AE report reconciliation process. This technology generates XML files for adverse reaction reports with meticulous precision and speed.
Once created, these XML files are ready for immediate import into your safety database, significantly reducing manual workload and preserving accuracy in data reporting.
Benefits:
- Efficient process: By automating labour-intensive tasks such as data entry, MedDRA coding, and narrative creation for AE reports, Innomar’s solution reduces the time spent on manual processes. The resulting XML files are ready to import into the safety database, allowing your team to focus on more strategic initiatives while maintaining consistency in data reporting.
- Compliance: Innomar’s tool meets Health Canada’s validation requirements and operates within a robust SOP-driven process for XML creation. Since its implementation, it has been routinely used for processing Canada Vigilance Adverse Reaction Reports across more than 40 products. This extensive experience underscores our commitment to excellence and our ability to deliver results that consistently meet stringent regulatory demands.
- Flexible resources and expertise: When you work with Innomar Strategies, you have access to flexible resources to support your needs. Our team includes over 100 pharmacovigilance professionals with extensive healthcare backgrounds, such as physicians, nurses, and pharmacists.
By integrating our automated tool into your pharmacovigilance processes, you can better manage Canada Vigilance Adverse Reaction Reports volume and regulatory compliance while optimizing resource allocation. This comprehensive solution is meticulously designed to keep you ahead in an ever-evolving regulatory landscape.
The contents of this piece contain marketing statements and do not include business or legal advice.
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