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Quality Management System in Clinical Research

SERVICE MERCATO CLIENT CRO (Contract Research Organization) operante a livello nazionale e internazionale YEAR 2011 - 2019 in progress

Client brief

Provide assistance and support for the revision and updating of the quality management system and various extensions of the related certificate.

Project challenge

The project is related a field of clinical research that is well-regulated

Solution

Collaboration with the client and a number of internal stakeholders to define an efficient, high-performance management system in line with the specifications required by legislation and the E.U. Good Clinical Practice guidelines.

Esecution phases

FASE 1

Overall analysis of the business, its management system and update status;

 

 

 

 

FASE 2

Support in the definition of the “Rules of engagement” between the two companies;

 

 

 

 

FASE 3

Overall system review;

 

 

FASE 4

In-depth analysis of stakeholders, their expectations, communication methods and applicable SOPs (Standard Operating Procedures);

 

FASE 5

Context analysis involving corporate management (general, scientific and administrative roles);

 

 

FASE 6

System update with respect to the UNI EN ISO 9001:2015 standard;

 

Achieved results

Extension of the certificate to MTA SWISS and then to the Milan office, upgrading to the 2015 edition of the UN EN ISO 9001 standard, complete integration of the management systems of the two companies, good compromise between the requirements of Good Clinical Practice (GCP) and efficiency linked to the ISO philosophy, training and support to the various QAMs that have followed.

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