ISO stands for “International Organization for Standardization”, an international organization whose task is to define the technical standards that a Company must comply with in order to meet specific evaluation parameters.

These voluntary certifications certify the organization’s compliance with evaluation criteria aimed at establishing the presence of specific elements in the business processes taken into consideration.

OPIS quality management system is ISO 9001: 2015 certified to ensure that the services offered always meet the customer’s requirements and that the continuous improvement of processes leads to the highest standards of quality and efficiency.

The ISO 9001 certification standard defines a quality management system model focused on the performances in relation to Customer Satisfaction and compliance requirements.

The increasing importance of the risk-based approach given in the 2015 edition of the standard is in line with the ICH GCP (R2) and with the EMA and FDA guidelines. As a matter of fact, the risk management approach helps companies to maximize efforts and resources where it is most relevant, resulting in greater proactivity, higher quality and better services.

OPIS is also ISO 27001 certified for information security management. This certification also reinforces the aspects of safeguarding the confidentiality, availability and integrity of the data.

OPIS quality culture is integrated into the entire clinical trial management process and the Quality Management Unit is responsible for defining and continuously improving the quality of the processes, data and documentation associated with the clinical research activities carried out by the Society.

The responsibilities of the Quality Management Unit include:

• management of the Integrated System for Quality and Information Security (ISO 9001 and ISO 27001 certification)
• preparation and management of the internal audit plan
• quality assurance for clinical studies
• point of reference for all ICH-GCP issues and more generally GxP
• preparation of training contents on Quality and GxP
• support in the preparation of audits / inspections at the center
• ad hoc activities based on the needs of the Sponsor

Furthermore, the Project Control function ensures that every step of all activities relating to your clinical research projects is carefully kept under control.

Our expert staff:

• ensures that the requirements and deadlines specified in the contracts and /or procedures of the Sponsor and OPIS are met
• provides study progress reports to the team
• prevents problems relating to timing, compliance with the activities set out in the monitoring plans, patient enrollment, study metrics and indicators and contractual requirements
• facilitates the sharing of information by organizing periodic meetings
• identifies potential interfaces with the Sponsor’s systems
• ensures the monitoring and calculation of the Key Performance Indicators.