Good Clinical Practices and Pharmacoviligance

In the changing pharmaceutical industry, companies are constantly filing drug applications for new medicines and new markets for existing medicines

This process has increased its complexity over time, involving multiple business areas and outsourcing some activities to Contract Research Organizations (CROs).

Good Clinical Practice

Pharmaceutical Industry should ensure that the requirements of Good Clinical Practice (GCP) are met, as well as the correct management and statistical processing of the associated data

Once the medicine is in the market, it is necessary to have a Pharmacovigilance system to properly manage the adverse events detected, in order to effectively detect and evaluate all potential problems. The Pharmacovigilance system should have an adequate Quality Management System and organization, as well as well-established processes to ensure compliance with Good Pharmacovigilance Practices (GVP).

Clinical Trials

Good Clinical Practices and Pharmacovigilance

Rephine’s experience in GCP and GVP includes:

Implementation of Quality Systems in medical research departments, pharmacovigilance departments and CROs.
Internal audits and audits to CROs and Pharmacovigilance Managers worldwide
Audits of clinical trials and bioequivalence studies
Validation of software related to clinical data management, statistical calculations with clinical data and pharmacovigilance data management

This process has increased its complexity over time, involving multiple business areas and outsourcing some activities to Contract Research Organizations (CROs), often located in many different countries.

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