Who We Are

OPIS is a full-service Contract Research Organization (CRO) founded in 1998 in Italy, providing premium trial management for multi-country clinical trials, including state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of current projects. OPIS extensive expertise can cover all phases of drug related trials, with no restrictions to therapeutic area as well as clinical investigations for medical and diagnostic devices, Investigator Initiated Trials (IITs), and compassionate use programs.

OPIS also manage clinical investigations for medical nutraceutical/food supplement studies.

With over 21 years of extensive experience in a wide range of therapeutic areas.

With profound medical, scientific and technological know-how, full-service projects are executed in compliance with regulatory requirements, ICH-GCP E6 guidelines and with therapeutic-specific attention.

Operational staff include medical writers, regulatory experts, project managers, monitors as well as data managers, biostatisticians, SAS programmers and system developers.

The OPIS EDC solution Clinical.net is FDA 21 CFR Part 11 compliant and fully customizable to digitally manage all clinical trial data.