Season's Greetings from all of us at ADAMAS. We would like to thank you all for following our blog over the course of the last year and hope you will continue to do so in 2015. Please click the link below to see our Christmas Card. Click here to see the ADAMAS...
This year's RQA conference with the theme Quality, Quo Vadis? (Quality, where are we going?) will be held at the Grand Hotel, Brighton on the 12-14 November 2014. The conference programme consists of plenary and parallel sessions, QA Clinics, workshops and excellent...
On 25-Apr-14, the MHRA issued a press release indicating that the definition of a critical GCP inspection finding had been changed. It now includes ‘Where provision of the Trial Master File (TMF) does not comply with Regulation 31A 1-3, as the TMF is not readily...
A Trial Master File (TMF) is the collection of documentation that allows the conduct of the clinical trial, verification of the integrity of the trial data and demonstrates compliance of the trial with Good Clinical Practice (GCP). Today, clinical trials take place at...
The deadline for industry comment on the EMA draft reflection paper on GCP compliance in relation to trial master files (paper and/or electronic) (TMF) for management, audit and inspection of clinical trials was 30 April 2013. The draft paper included several recent...
As I start to write this blog I have to admit this is not a topic in which I consider myself an expert. I think more of as a pessimist actually. I have never had a negative experience with a Monitor as a translator during an audit BUT nevertheless, I take a few...
I manage a small group of people. I engage with colleagues. I audit investigator sites around the globe. I have worked for small companies and huge companies. I have red hair. I have a few soap boxes (for those of you not familiar with the concept of a “soapbox”,...
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...
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