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
BSMA Europe (Bio Supply Management Alliance) Award received in October 2024 for the CleanWeb™-RTSM module, which streamlines supply management for randomised trials
A LEADING POSITION AND
AN INTERNATIONAL DEPLOYMENT
64 +
countries
involved
20 000 +
investigational
Centres
3 million +
patients
in database
50 000 +
users
worlwide
January 30, 2025
MedtechDive Artificial intelligence was a topic of focus for the medical device industry in 2024. Companies including GE Healthcare, Medtronic and Dexcom touted new AI features, and others like Stryker and Quest Diagnostics added AI assets through M&A. Meanwhile, conversations about regulations and generative AI, models that are trained to create new data including images and text, dominated medtech conferences. The Food and Drug Administration recently […]
January 30, 2025
BioPharm International FDA published a final guidance on Jan. 2, 2025 for those interested in participating in the agency’s Advanced Manufacturing Technologies Designation Program, which was developed to facilitate drugs manufactured using advanced manufacturing technologies (AMTs). The guidance, Advanced Manufacturing Technologies Designation Program, is the final version of the draft document issued on Dec. 13, 2023. […]
January 30, 2025
Applied Clinical Trials Online Medable has shared new data from the Tufts Center for the Study of Drug Development (CSDD)’s PACT Consortium linking decentralized clinical trial (DCT) approaches to a higher rate in participation across multiple demographic groups. The new research shows that a more strategic implementation of DCT elements, combined with increased regulatory oversight, […]