Clinical Research and Statistics

In Clinical Research, Statistics plays a prominent role in regulatory submissions. Statistical analysis of Pharmacovigilance can be achieved by several guidelines mainly ICH guidelines. Adverse Drug Reactions reports can also be considered for the regulatory submission.

Market Analysis:

The global clinical trials market size was valued at USD 40.0 billion in 2016 and is expected to grow at a CAGR of 5.7% over the forecast period. According to BioOutsource, the demand for Biosimilars testing is expected to increase in the U.S. This is attributed to the fact that the FDA finally started addressing the lack of clear guidance with regards to biosimilars, specifically how the developers should prove that their drugs are similar to that of the originator product. In January 2015, Hospira submitted one of the biosimilar versions of Epogen (Epoetin Alfa) and the result of the review in the U.S. is anticipated from the FDA within a year.

Related Companys: ChilternCharles River LaboratoriesPPDIconinVentiv HealthParexelCovanceQuintiles

Societies and Associations: Academy of Physicians in Clinical Research (APCR), American Association for Cancer Research (AACR), American Federation for Medical Research (AFMR), American Statistical Association (ASA), American Society for Clinical Investigation (ASCI), Association of Clinical Research Organizations in the Netherlands (ACRON), Society for Clinical Data Management (ACDM), Association of CROs Czech Republic (ACRO-CZ).

 

  • SAS Programing in Clinical Research and Pharmacutical Industry
  • ICH guidelines for clinical research and its statistics
  • Case reports on drugs used in pregnancy and lactation

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15th World Congress on Medicinal Chemistry & CADD

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Clinical Research and Statistics Conference Speakers

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