We are always looking for ways to improve services to our clients and we are therefore delighted to share some exciting news! We have engaged a new Safety Database Provider; we will be working together with ArisGlobal!
What is ArisGlobal?
It is a prestigious Safety Database Provider fully E2B(R3) compliant with regulations from ICH, FDA, EMA and PMDA, including all regional variations.
ArisGlobal has 30-plus years of safety experience and it is used by 35 of the top 50 global pharmaceutical organisations. Also, it is fully compliant with GDPR.
ArisGlobal certifications includes:
- ISO 9001:2015 Quality Management Systems requirements
- ISO 27001:2013 Information Security Management System requirements
- CMMI – Level 3 Appraisal Framework for Standardisation and Institutionalisation of Process
- SOC2 Type II Assessment.
ArisGlobal is a fully validated system, that uses a pre-validation approach on a hosted platform.
Why are we changing to a new safety database?
Whilst our current database meets all the necessary standards and requirements, ArisGlobal will provide a number of improvements and benefits to our clients including:
- Agility to ensure compliance with continually evolving regulations
- Improved functionality to support continuous regulatory reporting compliance in the most cost-effective manner possible
- Streamline procedures at Regulis.
If you would like to discuss your requirements for pharmacovigilance support, please don’t hesitate to contact one of the PV team.