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.
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.
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"OPIS was the excellent choice to transition a critical project to a qualified team that delivered on their promises and obtained great results."
- Mid-Size Pharma Company -
"The close collaboration with OPIS was instrumental to guarantee high methodological standards, fundamental requirements for any new clinical development and the international registration of new drugs."
- Mid-Size Pharma Company -
"We would like to recognize the skill and hard work of each member of OPIS team who worked on this important clinical trial. Thank you for your support in providing site recruitment, initiation and management, timely subject enrollment, monitoring and project management."
- Large Pharma Company -