Within research, for a Quality department to be effective, it is essential that they retain independence from those within the Clinical organisation. This reduces any influence from the Clinical group on the work of the Quality department. However, it is also...
We would like to take this opportunity to wish our readers, clients and partners continued success going forward into 2014. We are grateful to you as the figures regarding the readership of the blog continue to climb steadily. Follow us on our social media streams or...
Source data is being collected utilizing electronic methods. This is seen at a site (for example via electronic medical records) but also subjects are being asked to provide data electronically. This could include an interactive voice/web response system or even...
Hi everyone, we hope you are all looking forward to the 1st European QA conference in Bonn, next week, as much as we are. The conference will be a great opportunity for the European Quality Assurance community. It is an exciting prospect to finally meet and share...
An ADAMAS project refers to the contractual deliverable that is established with a client. This can be a one-off specialised audit or, in some cases, a larger programme of audits. Examples of where ADAMAS has been involved in large projects include instances where...
The ADAMAS Consulting US based staff will be attending the 29th annual SQA meeting in Indianapolis from 29-April through 03-May. Vaska Tone, Vice President of ADAMAS Consulting LLC will be presenting on the topic of FDA and EMA joint inspections, EMA/MHRA inspection...
With 56% of the world’s population residing in Asia, it is an attractive destination for clinical trials. However, maintaining the quality and integrity of the clinical research data in the emerging markets has always been a challenge for the pharmaceutical,...
An auditor should provide a clear and concise report relating to an audit to demonstrate and explain all non-compliances observed during the audit. In addition, it is important that auditees are aware that the responses provided to an audit report are important...
Although medicinal products for use in adults undergo extensive pharmacological, stability and toxicological testing through clinical trials, this same approach has not always been applied to medicinal products to treat children. As a result, many products are used...
Two new GVP modules were published in December 2012, Module III - Pharmacovigilance Inspections and Module IV - Pharmacovigilance Audits, bringing the total of final modules to nine. It is expected that the remaining modules will be finalised and published in 2013....
From Reactive Compliance to Strategic Partnership: How Clinical Quality Is Evolving
RQA 8th Global QA Conference 2026 | London, UK
FDA’s Real-Time Clinical Trial Initiative: Endorses Data-Enabled QA Oversight
SCOPE Europe 2026 | Barcelona, Spain
Beyond Audit Cycles: A Risk-Based Approach to Regulatory Excellence in Pharmacovigilance