Expertise
As data-driven and quality-focused clinical CRO, OPIS collaborates with numerous international Sponsors on multi-country interventional as well as non-interventional trials. OPIS teams have sound experience in a wide range of therapeutic areas, new-generation drugs, advanced therapeutic procedures and biologic treatment options.
Medical and scientific expertise in combination with technological and operational know-how have earned OPIS established partnerships with numerous pharma and biotechnology and medical device clients.
Medical Devices
OPIS collaborates with expert consultants in the industry and a team of UNI EN ISO 14155 trained staff to assist clients through challenging clinical compliance issues.
Services
OPIS provides full-service, 360° clinical trial support from study concept creation and protocol development to full project execution, study data handling and up to study closure, analysis and reporting.
OPIS operates internationally with flexible business models and fully, ICH-GCP -trained operational staff. Our systems are ISO 9001:2015, ISO 27001:2014 and FDA 21 CFR Part 11 compliant.
Over 21-years of experience in clinical trial management and monitoring by proficient and well-trained international clinical operational staff.
An OPIS team of experts assist clients with regulatory aspects related to clinical studies submissions (Phase I-IV, observational), medical device and nutraceutical products authorization processes.
OPIS provides clients with sound scientific advice, medical and methodological considerations of the highest standards and assists clients to overcome regulatory and/or pharmacological obstacles.
OPIS Medical Affairs Unit has been created with the aim of enhancing the medical-scientific oversight of research activities carried out across the Company.
OPIS offers a comprehensive and flexible suite of safety monitoring services such as pharmacovigilance, phytovigilance and Medical Device Vigilance and Surveillance, for drugs, nutraceuticals and medical devices.
To ensure quality of performance and data OPIS has established a Quality Management System based on OPIS´ standard operating procedures (SOPs) and OPIS Policies.
Data Management & Biometry OPIS provides study data handling tools to guarantee scientifically sound study objectives.
More than just EDC. Fully customizable modular framework completely developed by OPIS.
News
Visit this area to read our latest news and to find out how OPIS can assist you in your clinical drug development programmes.
Case Study
To see how OPIS delivers excellence clinical trials, please click here to find out some recent case studies.
Contact Us!
Whether you are Sponsor, a Clinical Research Professional or an Investigator contact us to learn more about how we can help.
