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Pivotal's Solutions
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- Develop a QA Plan for
every project
- Assign a QA Monitor
for every project to oversee the QA Plan
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A quality control monitor
is assigned at the initiation of each clinical
trial project at Pivotal Research. This quality
control monitor is responsible for preparing a
QA plan that includes:
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- Pre-Trial Documentation
(protocol, CRF, informed consent)
- Essential Documentation
Audits
- Investigator Site Audits
- Database Audits
- Clinical Study Report
Audits
- Pre-regulatory Inspection
Audits
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