/Tag: ANDA
12 07, 2017

Navigating through the Clinical Trial Authorization Process in Russia

By |2020-02-07T11:44:41+00:00July 12th, 2017|Tags: , , |

Sponsors consider Russia as an attractive study venue due to the countries higher enrollment and patient retention rates and lower overall cost. This paper outlines the regulatory requirements for obtaining regulatory approval for clinical studies and addresses certain practical aspects of regulatory submissions in Russia.

12 07, 2017

Patient Numbers Required In Clinical Endpoint ANDA Trials

By |2020-02-07T13:24:58+00:00July 12th, 2017|Tags: |

The number of patients required in a trial is one of the cornerstones of the trial design. This number is calculated by using statistics, but the validity of any estimated number is totally dependent on certain assumptions. So before the estimates can begin, there are somekey questions that need to asked and answered. Read more in this Clinical Endpoint ANDA Program Optimization White Paper Series

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