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The Role of a Statistician In a Pre-Clinical Study

Statistical Consultancy Team

Pre-clinical trials, involving experiments in-vitro (literally ‘in glass’, i.e. in the laboratory, typically involving cells) and in-vivo (‘in animals’) are an essential part of drug development as it is a regulatory requirement  to investigate the safety of new drugs in-vitro and/or in-vivo before they are tested in humans. These trials can also be used to investigate the potential efficacy of new compounds.

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Topics: Pharmacokinetics and Pharmacodynamic, Randomization, Specialist Biometrics CRO, Pre-Clinical Study, Biostatistics Consulting

The Different Phases of Clinical Trials

Medical Writing Team

The development of investigational new drugs (INDs) involves performing clinical trials (or studies) to assess the safety and efficacy of the IND in humans.  These trials are usually classified into 4 phases of development (Phase 1 to 4), with each potentially lasting for several years.  Successful completion of each phase and approval by the appropriate regulatory authority or authorities (the European Medicines Agency [EMA] in the European Union, Food and Drug Administration [FDA] in the United States, Health Canada in Canada, or the Ministry of Health, Labour and Welfare in Japan) is required for progression to the next phase.

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Topics: Pharmacokinetics and Pharmacodynamic, Phase I Studies, Pre-Clinical Study, Clinical Trial Phases, Phase 3 Studies, Phase 4 Studies, Phase 2 Studies

An Introduction to Industry Training Course Review - Statisticians in the Pharmaceutical Industry

Statistical Consultancy Team

A Member of Quanticate’s Statistical Consultancy Team writes about their experiences whilst attending the course entitled “PSI Introduction to Industry Training Course”.

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Topics: Statistical Programming, Pre-Clinical Study, Biostatistics Consulting, Statisticians in the Pharmaceutical Industry (PSI)

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