Pharmacovigilance (PV) has been the rising regulatory star since the introduction of European Union (EU) legislation in 2012 which continues to be an inspiration for other regulatory authorities worldwide. Many authorities place a significant focus on PV inspections...
Introduction The COVID-19 pandemic has imposed unprecedented challenges on Sponsors, Investigator Sites and Clinical Trial participants. The potential risks of this global COVID-19 outbreak include: Rise in Good Clinical Practice (GCP) non-compliance Increase in the...
The ICH guideline for Good Clinical Practice states that sponsors should evaluate identified risks against existing risk controls by considering “the likelihood of errors occurring, the extent to which such errors would be detectable, and the impact of such errors on...
Following the recent confirmation from Regulatory Authorities that GxP compliance should be maintained during the coronavirus outbreak, encouraging alternative approaches for routine regulatory oversight, remote auditing represents the viable alternative during these...
Thanks to many common place technologies, conducting remote audits has become more effective and offers a potential solution where security, travel or other factors may impose restrictions upon traditional in-person and on-site audits. While remote audits may not...
As COVID-19 Brings Global Uncertainty, Can We Maintain Certainty Regarding Our Regulatory Obligations? ADAMAS has brought together a range of specific remote service offerings which will not only ensure you can maintain compliance, but also have peace of mind that...
Although disappointed that the event has been cancelled, ADAMAS Consulting fully support the SQA's sensible decision under the current circumstances surrounding COVID-19. We are looking forward to seeing you all healthy and well next year at the 2021 SQA in New...
Season's Greetings from ADAMAS Consulting. We look forward to working with you next year, and hope you have a fantastic festive holiday. The ADAMAS Team. Watch our Season's Greetings Video.
The biggest annual conference of its type in Europe, this is an event I was looking forward to and I was especially pleased to see it was taking place in Dublin this year. Along with my colleagues Richard Brown (CSC Consultant) and Ian Brady (Executive Director,...
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...
Come and meet ADAMAS Consulting at the RQA European QA Conference, Belfast
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