Our Clinical Operations team is dedicated to the planning and execution of clinical trials and clinical investigations, providing a single point of contact for the sponsor.
Project management is entrusted to highly qualified personnel who take care of all phases of clinical development of drugs, medical devices and food supplements, characterised by a project-oriented approach, with accurate risk, time and budget management.
With in-depth medico-scientific knowledge and a wide experience in clinical studies management, from First In Human to pivotal studies, from interventional to observational clinical trials, PRINEOS is able to support its clients in achieving their objectives, adapting to the organisational, therapeutic and economic needs of the project in compliance with current regulations.
Our Clinical Project Managers, with solid clinical experience, handle the site selection process, ensuring accurate resource assessment and effective communication with all stakeholders.
PRINEOS offers a complete service for the selection, evaluation and management of trial centres, providing support to the client in the submission process, training of involved personnel and site activation.
Project Control is a key element in the success of our clients' projects: we constantly monitor the progress of the research project, identifying potential risks and ensuring it is on time and on budget. We provide the client with detailed, customised reports to ensure complete visibility of the project's progress. Study sites are managed by a network of experienced and qualified CRAs operating across Europe. We use flexible, risk-based monitoring models to ensure efficiency and quality.
Our Clinical Operations team takes care of the creation, management, verification, archiving and destruction of all documentation related to clinical research projects, ensuring compliance with current regulations.
PRINEOS ensures the proper management of archives, both paper and electronic, and their preservation in compliance with regulatory deadlines.
Our project managers will be your main point of contact, ensuring clear and timely communication at every stage of the project. In addition to coordinating all activities, they will provide you with progress reports and will always be available to answer your questions. You can then focus on the strategic aspects of the project, knowing that the operational management is in the hands of an experienced professional.
PRINEOS offers comprehensive management services for your external suppliers by selecting the most competitive suppliers and negotiating favourable contractual conditions. From the initial qualification of suppliers, through performance management, to the resolution of any issues, our team provides comprehensive support to optimise your supply chain: by constantly monitoring supplier performance, they will identify opportunities for improvement and cost reduction, thus contributing to the success of your clinical trial.
Our team will assist you in creating a robust and comprehensive study management plan, identifying possible risks related to patient safety, data quality and regulatory compliance, and developing customised mitigation plans. You will constantly monitor the effectiveness of the measures implemented, providing regular updates on the status of the project. As a result, you can be sure that your clinical trial will proceed safely and efficiently, in accordance with current legislation, the ICH-GCP E6 guidelines and specific therapeutic requirements.
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