Qualitus - Clinical Quality Assurance Audits

Audits typically include: preparation of a detailed audit plan, audit conduct and writing the audit report.

The scope and extent of each audit can be adapted to customers’ individual needs, for example to include audit follow-up activities.

The types of audit available are as follows:

Clinical investigator site (Phase II, III and IV)
Phase I unit
Final clinical study report
Clinical expert report
System audits (e.g. pharmacovigilance, IVRS)

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