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ICH (E6) R2 Addendum – Step 4

Date December 8, 2016

The ICH E6 (R2) has been formally adopted by the ICH assembly held in Osaka, Japan on 5-10 November 2016. All changes proposed...

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ADAMAS at RQA’s Annual Conference in Brighton, UK 9–11 November 2016 Stand#7

Date November 2, 2016

“The RQA 2016 Annual Conference will be held at the Hilton Brighton Metropole 9-11 November 2016” Representing ADAMAS at this year’s RQA Conference...

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The ADAMAS Centre of Excellence (ACE)

Date October 14, 2016

ADAMAS Consulting (ADAMAS) is one of the world’s leading global providers of research Quality Assurance (QA) services offering auditing and consulting resources for...

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ADAMAS is 19 years old today!

September 1, 2016

ADAMAS was born (officially) on 1st September 1997, the year when the ‘new’ ICH GCP Guidelines were released – a happy coincidence in...

The Indian Central Drugs Standard Control Organization (CDSCO) relaxes two crippling restrictions imposed since 2014!

Date August 4, 2016

According to the Office Order dated 03-Jul-14 issued by the CDSCO, a Principal Investigator could not conduct more than three (03) clinical trials...

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What do you look at when auditing bioanalytical source data?

Date July 1, 2016

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...

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