PlasmidFactory GmbH & Co. KG

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Further Collaborations OPIS s.r.l.

Via Matteotti 10 20832 Desio Italy Giovanni Trolese +39-0362-633-1 +39-0362-633-633 office@opiseurope.com www.opiseurope.com www.clinical.net

I

ca. 240 1998

Premium support for clinical drug and device development

€ 30 m

Pharma

| Pharma | Biotech | Medical device | Food supplements

Our organisation

OPIS is a Global clinical CRO providing premium clinical trial management for multi-country trials. In addition to phase I-IV drug-related trials, OPIS also manages pre- and post-marketing clinical investigations for medical and diagnostic devices, as well as nutraceutical/food supplement studies. Founded in 1998, OPIS is a premium Global CRO, with roughly 300 employees. The company operates from its Italian headquarters and twelve other offices located around the world ( Spain, France, Germany, UK, Belgium, Sweden, Poland, Switzerland, The Netherlands, United States, Taiwan, and Australia).

Our expertise

In 23 years of combining medical, regulatory, statistical, and technological expertise, OPIS has assisted a huge number of different clients with interventional and observational trials. Full-service projects in a wide range of therapeutic areas include various rare disease indications as well as pediatric studies. Currently, over 40% of trials managed by OPIS are oncology or onco-hematology trials. Other major therapeutic areas include ophthalmology, neurology, and cardiology. OPIS has established a solid collaboration with numerous international sponsors on multi-country trials.

Our mission

We draw on our know-how, experience, professionalism, and ethical values to assist our partners in developing drugs in compliance with laws and regulations, while achieving the objective at a quick paste. Our strength lies in the passion for what we do and in the quality with which we deliver. We believe that clinical studies, particularly those incorporating scientific and methodological innovation, can significantly contribute to medical progress and to better quality of life.

Our core business

OPIS provides clinical research services and drug development consultancy to pharma, biotech, and Medical device IBM. From early phase clinical trials through proof of concept and up to late phase and post-market research, projects are executed in compliance with regulatory requirements, ICH-GCP E6 guidelines, and with therapeutic-specific attention. Operational staff that include medical writers, regulatory experts, project managers, and monitors as well as data managers, biostatisticians, and SAS programmers assist sponsors with full-service study management of multi-country trials. The clinical trial data handling solution Clinical.net is fully FDA 21 CFR Part 11-compliant and modular in design to digitally manage EDC, protocol deviations, patient randomization, safety reporting, and study drug handling.

Study types

› Early phase trials › Phase I to IV › Pre- and post-market studies › Observational research › Real World Evidence studies › Investigator Initiated Trials › Medical Device Clinical Investigations › Nutraceutical studies

Services

› Medical Affairs and Medical Writing › Regulatory › Trial Start-Up › Data Management › Pharmacovigilance › Quality Assurance › e-Clinical Platform › Project Control › Statistical Analysis and Consultancy › Study Management and Monitoring › Preclinical and Drug Development Consultancy › Training