ADAMAS Consulting, a global independent Quality Assurance and Quality Management System consultancy, will be exhibiting at this year’s ExL Clinical Quality Oversight Forum this week in Philadelphia. The Forum focuses on ensuring clinical trial integrity by...
CQA
18 Years of Independent GXP Quality Assurance
ADAMAS Consulting started on 1st September 1997 with five full-time auditing staff, based in the UK, but operating globally. ADAMAS’s business goal was “to become the global independent pharmaceutical Quality Assurance service provider of choice” – so how have we...
RQA Regional Forum “Audit vs Inspection”
Mark Poulton recently presented a presentation at an RQA regional forum meeting (Scotland and English Borders, 29-Jan-15) entitled “Audit vs Inspection”. This presentation was intended to awaken minds to the similarities between audits and inspections and to make...
Two ADAMAS senior staff featured in the RQA journal ‘QUASAR’
ADAMAS was pleased to have two of its senior staff featured in the July edition of the RQA journal ‘QUASAR’. A professional and personal profile of Dr Christine Henderson, who is a Board Member of RQA and the Quality and Training Director of ADAMAS Consulting, was...
ADAMAS Consulting Awarded Best Poster at SQA 2015
Dana Beck, one of our leading Consultants for ADAMAS Consulting in the Americas, was recently honoured by the Society of Quality Assurance and awarded the “Best Poster” accolade at the SQA 2015 Annual Conference held in Tampa, Florida the week of April 12th. Her...
The ADAMAS Team at SQA 2015
Educational’, ‘Enlightening’, ‘Thought provoking’……these were, repeatedly, heard comments that were only surpassed by the new relationships that were forged at this year’s 31st SQA Annual Conference held in Tampa, Florida. More than 750 people attended this year’s...
Changing Landscape of TMF Management Part 2
Having a TMF entirely on paper, stored in filing cabinets (even the fancy compactors), is now thought to be unsustainable. Many companies are now in the process of transitioning to eTMF’s, resulting in a hybrid of paper and shared file drives, which are also...
Changing Landscape of TMF Management Part 1
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...
Clinical Research Tribulations: India
India, with its large disease burden and experienced medical professionals, has been actively contributing to the global drug development, for more than a decade. However, the recent changes to regulations, although intended to safeguard patient rights and ethics, has...
To Be or Not to Be Present; the Monitor as a Translator
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...