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Clinical Studies In Japan Today: Another Look At The World’s Second-Largest Prescription Drug Market In A Post-Pandemic World

The Latest Insights into Clinical Studies in Japan The Pharma [...]

By |2022-01-20T13:13:05-05:00January 12th, 2022|Comments Off on Clinical Studies In Japan Today: Another Look At The World’s Second-Largest Prescription Drug Market In A Post-Pandemic World

[Whitepaper] Drug Manufacturing And Development In The Age Of Precision Medicine

Development and Manufacturing: Insights into the Precision Medicine Model  Download [...]

By |2020-07-28T11:21:15-04:00July 28th, 2020|Comments Off on [Whitepaper] Drug Manufacturing And Development In The Age Of Precision Medicine

[White Paper] How the fast-changing R&D pipeline is amplifying the importance of adaptable CROs

The story of CMIC’s rise from being a startup in [...]

By |2020-08-13T04:16:42-04:00June 10th, 2020|Comments Off on [White Paper] How the fast-changing R&D pipeline is amplifying the importance of adaptable CROs

[White Paper] Recommendations on the interpretation of the new European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC)

Senior representatives of GCC member companies have thoroughly evaluated and discussed the new European Medicines Agency (EMA; July 2011 [1]) Guideline on Bioanalytical Method Validation (BMV), during the 4th GCC (23 October 2011, Washington DC, USA) and 5th GCC (14 November 2011, Barcelona, Spain) Closed Forums. These North American and European events provided a unique opportunity for CRO leaders to openly share opinions and perspectives and to agree on unified bioanalytical recommendations specifically in relation with the new EMA guideline.

By |2019-11-21T14:27:41-05:00November 20th, 2019|Comments Off on [White Paper] Recommendations on the interpretation of the new European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC)

[White Paper] Recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for Bioanalysis

The 2nd Global CRO Council (GCC) for Bioanalysis Closed Forum was held on 15 April, 2011 in Montreal, Canada. In attendance were 45 senior-level representatives from 39 CROs on behalf of eight countries.

By |2019-11-21T14:26:55-05:00November 20th, 2019|Comments Off on [White Paper] Recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for Bioanalysis

[White Paper] Recommendations on Incurred Sample Stability (ISS) by the Global CRO Council (GCC)

The topic of Incurred Sample Stability (ISS) has generated considerable discussion within the bioanalytical community in recent years.  The subject was an integral part of the 7th Annual Workshop on Recent Issues of Bioanalysis (WRIB) held in Long Beach, California, USA, in April 2013, and at the Global CRO Council (GCC) meeting preceding it.  

By |2019-11-21T14:26:07-05:00November 20th, 2019|Comments Off on [White Paper] Recommendations on Incurred Sample Stability (ISS) by the Global CRO Council (GCC)

[White Paper] GCC Recommendations on Bioanalytical Method Stability Implications of Co-administered and Co-formulated Drugs

An Open Letter written by the GCC describing the GCC survey results on stability data from co-administered and co-formulated drugs was sent to multiple regulatory authorities on 14 December 2011. This letter and further discussions at different GCC meetings lead to subsequent recommendations on this topic of widespread interest within the bioanalytical community over the past two years.

By |2019-11-21T14:23:31-05:00November 20th, 2019|Comments Off on [White Paper] GCC Recommendations on Bioanalytical Method Stability Implications of Co-administered and Co-formulated Drugs

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