The CRC is in full compliance with International Good Clinical Practice (GCP) standards and is Certified according to the UNI EN ISO 9001:2008 standard; transition to the 9001:2015 ISO standard is currently ongoing.
The CRC Quality Management System (QMS) comprises our mechanisms for ensuring that all our services are performed to the highest ethical standards, conform to all regulatory requirements and satisfies contractual obligations.
We continually improve the effectiveness of its QMS through a systematic approach, starting from defining and planning strategy and objectives in order to standardize implementation and compliance by a defined Quality Policy 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:
Quality Manual, which contains an outline of the QMS, gives an overview of all CRC processes and provides details on how ISO 9001 principles are interpreted and implemented within CRC.
Policies, which outline the principles for definition, implementation and control of the main business processes, according to the CRC mission and values.
Standard Operating Procedures, which describe the methodologies to be followed in the execution of a specific task in order to achieve uniformity, standardization and compliance with procedures.
Working Instructions, which provide detailed and technical instructions to execute specific tasks.
Templates and Forms, mostly associated to SOPs and WIs, which are used to document the activities described in the procedures.
Periodical evaluations of the CRC Quality System are done by an external consultant, according to an annual audit plan.
Internal quality control assessments are regularly performed by internal personnel, covering the key activities related to the execution of study trial.
Furthermore, audits are regularly performed by Sponsors.