The FDA’s new CSA guidance aims to streamline CSV by promoting risk-based validation, reducing documentation, and enhancing quality and patient safety.
Industry Focus
Why Is Data Integrity Important When Transferring Data in a Clinical Trial?
Explore how a new validation model helps ensure data integrity in decentralized clinical trials, reducing compliance risk and enabling inspection readiness across complex systems.
Top 6 Tips for Inspection Readiness
Learn key strategies to ensure inspection readiness in clinical trials, from TMF accuracy to sponsor oversight, SME preparation, and quality-controlled documentation.
ADAMAS Spotlight: Vedraj Vellody
ADAMAS’s commitment to upholding our values of clarity, integrity and excellence is made possible by the calibre of its people, and the knowledge and experience they bring. It is this expertise and assiduous work ethic that our employees appreciate the most about one...
ADAMAS Spotlight: Chris White
It is because of our team of expert consultants with outstanding industry knowledge and exceptional client care that we are able to provide the highest caliber auditing services. Not only is the ADAMAS team composed of the most dedicated and experienced individuals in...
Superior Vendor Compliance Archiving
Discover how ADAMAS ensures long-term, inspection-ready access to audit records and documentation, supporting clients with reliable, compliant records retention.
Annual MHRA GPvP Inspection Metrics Report – Apr 2018 to Mar 2019
The Medicines and Healthcare products Regulatory Agency (MHRA) recently published their latest Good Pharmacovigilance Practice (GPvP) inspection metrics covering the period April 2018 to March 2019. Within this period a total of 18 inspections of Marketing...
Team Tuesdays: are we ready for the AI revolution?
One of the best parts of my job as a Quality Assurance Consultant at ADAMAS is getting out on-site to perform vendor audits. I love visiting new companies to discover the myriad of ways they’re using computers and tech. It’s always an education, and I especially like...
How to Outsmart the dreaded ‘Annual Disaster Recovery Test’
If there were not already enough tasks to complete and IT tickets to resolve, no one wants to carve away an entire day (or even take away a personal weekend) to shut all systems down - and ‘test’ the Disaster Recovery (DR) Process. The Disaster Recovery SOP serves to...
