ISO 9001:2015 certification
ISO 27001 HDS
and with ICH E6-E9, ICH Q9-Q10, European Directives 2001/20/EC / Directive 2005/28/EC, Annex 11, cGMP
CDISC-ODM Certification
Information System Validation:
GAMP-5 methodology
National Qualiopi certification,
a new quality guarantee for
training providers in France
64 +
countries
involved
20 000 +
investigational
center
2 million +
patients
in database
50 000 +
users
worlwide
97%
overall trainee
satisfaction rate
90+
monitored
servers
5 500+
projects
A LEADING POSITION AND
AN INTERNATIONAL DEPLOYMENT
64 +
countries
involved
20 000 +
investigational
Centres
3 million +
patients
in database
50 000 +
users
worlwide
September 2, 2024
17 September 2024 – 11am – 12:30pm EDT Register for this webinar to receive essential updates on the CDISC transition and learn about new regulations and initiatives impacting Trial Master Files (TMF). Don’t miss this opportunity to stay informed about the latest industry standards and practices. Read more and register: https://cdisc.zoom.us/webinar/register/WN_WqNz9_hiRVihH_pe1IEurA#/registration
September 2, 2024
Med City News Innovation is not just a luxury but a necessity in the realm of clinical trials, particularly as we strive to accelerate drug development. Yet, the slow pace of innovation within the U.S. clinical trials system has impeded progress, leaving many stakeholders frustrated. U.S. Food and Drug Administration (FDA) resource limitations cause the […]
September 2, 2024
International Biopharma Data integrity is critical in Biopharma manufacturing yet is often difficult to achieve due to complex regulatory requirements and legacy data management systems, among the many factors. Furthermore, issues such as data accuracy, completeness and security impact product quality, regulatory compliance and ultimately patient safety. Addressing all these challenges demands a multifaceted approach […]