In Apr-13, the Medicines and Healthcare products Regulatory Agency (MHRA) successfully prosecuted an individual for manipulating pre-clinical analytical data. Following identification of irregularities in the bioanalytical data, the MHRA was notified and the following...
Industry Focus
ICH (E6) Addendum – Impact Analysis
The Guideline for Good Clinical Practice (GCP) E6(R1) has been undergoing revision since Jun-15 and the revised guidance, the Integrated addendum E6(R2) (‘the addendum’) is planned for finalization soon. While the addendum includes few additions to investigator...
ADAMAS Consulting will be participating at this year’s Clinical Trial Middle East Conference in Dubai in November.
Established in 1997, ADAMAS is a leading global independent Quality Assurance and Quality Management System consultancy. Overall, ADAMAS brings more than 18 years of experience as a company conducting GxP audits and QMS projects. We’re different…with a global staff of...
ADAMAS' Experience at the RQA Annual Conference in Leeds
This year’s RQA Annual Conference, held in Leeds was attended by over 300 delegates and many attendees visited the ADAMAS stand in the exhibition hall. The Poster by Dr Annie Chen, ADAMAS Consultant “Conducting remote vendor audits” proved extremely popular and repeat...
Today, ADAMAS attends the 2015 Annual RQA Conference in Leeds
The name of the city of Leeds is derived from the old Brythonic word Ladenses meaning "people of the fast-flowing river", in reference to the River Aire which still flows through the city. The ADAMAS team at the RQA consists of Jerry Young, Business Development...
ADAMAS Brings QA Audit Benchmarking Metrics to MAGI West Conference
At this year’s 2015 MAGI West Conference in San Diego, October 11th – 14th, ADAMAS Consulting will feature the industry’s only benchmarking service of QA audit findings that gives Sponsors the ability to better compare their audit results to industry averages. For the...
Meet ADAMAS Consulting at ExL’s Clinical Quality Forum in Philadelphia
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...
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...
European Medicines Agency (EMA) Aims to Reduce Medication Errors
Medication errors are a major public health burden in the European Union (EU). They are the most common preventable cause of adverse events and are estimated to account for 18.7% – 56% of all adverse drug events among hospitalised patients in Europe. Medication errors...