Who We Are

A full service, phase I-IV clinical CRO e-Clinical excellence A reliable, cost-competitive solution

OPIS was founded in 1998 as a small Italian CRO. Over the past 20 years we have worked with passion and dedication to conquer the trust of clients and the scientific community, learning from each project and challenge convinced that investing in knowledge earns the highest interest. Today, OPIS HQ is the number one Italian CRO, with more than 250 employees. As an international level, OPIS manages both local and international full-service studies thanks to its offices located throughout Europe.

From its beginning, OPIS has managed complex and demanding projects in terms of study rationale and design, treatment features and patient characteristics. With time, this has led to the advancement of our main strengths: helping clients single out the best solution by putting forward positive and interesting proposals, flexibility, responsiveness, qualified personnel, cohesive and organized teams, and sustained monitoring of project status. OPIS has always been driven by a passion for research, a thirst for knowledge, and the desire to offer a personalized service that meets client needs without ever breaching the ethical and legal requirements that govern the conduct of clinical studies.

Corporate and Governance

Ethics Code

The implementation of a Code of Ethics by OPIS enshrines the principles of “company ethics” that the company recognizes as its own. The company demands that company bodies, employees and all collaborators observe these principles. The Code of Ethics is an integral part of the Organizational, Management and Control Model.

As a CRO, OPIS operates in a complex and ever-evolving market, in which it forges relationships every day with various stakeholders such as sponsors, health-care professionals, institutions, public bodies and suppliers.

In this context, OPIS has a moral and ethical responsibility that requires abiding by a set of values based on ethics, transparency, fairness, high professionalism and service orientation. These values are periodically reinforced through a compliance program, and create in our employees, company bodies and collaborators an awareness of, and profound opposition and intolerance to behavior and actions not in line with these values.

The purpose of the Code of Ethics is to promote or prohibit various kinds of behavior and represents a summary of the policies that guide the OPIS Group.

Ethics Code

Model ex D.Lgs. 231/01 Italian Version

With Italian Legislative Decree no. 231 of 2001, legal entities including limited companies may be held liable for certain crimes which are committed in the interest or for the benefit of the company.

In view of these regulations, OPIS designed a its Organizational, Management and Control Model, which contains the measures aimed at guaranteeing that company activities are carried out in compliance with the law and at finding and promptly eliminating any risks. To ensure continuous and effective vigilance over the functioning and observance of the model, the company has appointed an autonomous and professional Supervisory Body, which is also in charge of updating the model.

OPIS has given special consideration to communication initiatives, to the training of its employees and collaborators on the contents of D.Lgs. 231/2001, and to the way it is implemented in our company.

Model ex D.Lgs. 231/01 Italian Version

ISO Certifications

OPIS Quality Management System is ISO 9001: 2015 certified to ensure that the services offered consistently meet customer’s requirements, and that the continuous improvement of processes leads to the highest standards of efficiency and quality.  

In addition, the increased prominence of risk-based thinking given in the 2015 release of the standard is in line with ICH GCP (R2), EMA and FDA guidelines. The risk management approach helps the Company maximize efforts and resources where it matters the most, translating in more proactivity, higher quality and better services.   

OPIS is also ISO 27001:2017 certified for information security management, reinforcing the protection of confidentiality, availability and integrity of data.