C.R.C. c/o Policlinico G. B. Rossi
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37134 Verona - Italy
info@crc.vr.it

The Centro Ricerche Cliniche (Clinical Research Centre) is in full compliance with International Good Clinical Practice (GCP) standards and it has a UNI EN ISO 9001:2008 certification carried out by BSI S.r.l.. A high standard of quality and efficiency is guaranteed.

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CRC has established a Quality Management System (QMS) in order to meet the quality requirements of customers and stakeholders and to comply with regulatory requirements.
CRC continually improves the effectiveness of its QMS through a systematic approach, starting from defining and planning strategy and objectives, standardizing implementation and compliance by a defined Quality Policy, QMS and procedures, checking effectiveness and compliance by QA, QC, Management Review, data and project review, audits and customer survey results.
The CRC has several levels of Controlled Documents which support the maintenance and application of the QMS:
a)      Quality Manual, which specifies the QMS of CRC, gives an overview of all CRC processes and provides details on how the ISO 9001 principles are interpreted and implemented within CRC.
b)      Policies, which outline the principles for definition, implementation and control of the main business processes, according to the CRC mission and values. The Quality Policy reports general objectives and methods applied to reach them.
c)      Standard Operating Procedures, which describe the procedures to be followed in the execution of a specific task in order to achieve uniformity and standardization of the compliant performances. It also proposes the main objectives of the CRC Management and the instruments to achieve them.
d)     Working Instructions, which provide detailed information and technical details to execute a specific task.
e)      Templates and Forms, mostly associated to SOPs and WIs, which are used to document the activities described in the procedures.
QA activities for CRC are performed by an external consultant. An activity plan is set up annually and it usually includes at least 2 CRC Facility Audit and 1 Study-specific Audit.
Internal quality control assessment are performed at least 3 times a year by internal personnel covering the key activities related to the performing of study trial.
Furthermore, every year at least one Audit is performed by Sponsors.
The CRC is in full compliance with International Good Clinical Practice (GCP) standards and it has a UNI EN ISO 9001:2008 certification carried out by BSI S.r.l.
In October 2013, CRC received the first EUCROF Quality Certificate for Early Phase Units.