At this moment the FDA Center for Devices and Radiological Health (CDRH), in collaboration with the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER), are planning to release a new guidance document entitled...
This piece is an extract of the upcoming ADAMAS white paper “Making the Model: Solving the Data Integrity Challenge of Decentralized Clinical Trials”. Data integrity is an essential element of any data handling task. It goes without saying that if data isn’t accurate...
No matter if you're preparing for an imminent clinical trial inspection or if you're just bracing for a mock inspection, it is vital for you and your team to be prepared. Even so, establishing a culture of readiness can be difficult with each step presenting its own...
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...
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...
At ADAMAS we have made a commitment to all our clients to ensure safe, accurate and secure retention of critical information relating to the services we have provided. For example, the final version of audit reports as well as the CV and Training Record of the...
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...
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...
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...
Computer Software Assurance (CSA): Why the Change and What Does it Mean?
Annex 1 Revisions: What are the Changes and Whom will they Affect?
Why Is Data Integrity Important When Transferring Data in a Clinical Trial?
ADAMAS and Ergomed combine to expand global capabilities
ADAMAS Spotlight: Jean-Luc Salendre