Prineos
PRINEOS is a Contract Research Organisation (CRO) and strategic consulting company in the Life Sciences sector, dedicated to improving and innovating clinical research in healthcare. They offer personalized support across all stages of clinical development, aiming to accelerate time to market, reduce costs, and increase research success probability. Their mission is to enhance clinical research and contribute to scientific progress and quality of life.
Industries
Nr. of Employees
small (1-50)
Products
Regulatory Affairs & Quality Management
Comprehensive regulatory affairs support through all stages of a product’s lifecycle including preclinical assessment, clinical trials, CE marking, and post-market surveillance for medical devices, in vitro diagnostic devices, drugs, and food supplements.
Regulatory Affairs & Quality Management consulting
Support for regulatory affairs and quality management including management of Quality System (ISO 13485, 21CFR820, MDSAP) and CE marking of medical devices (Regulation MDR 2017/745 and IVDR 2017/746).
Clinical, statistical
Advice for Phase I-IV clinical trials, observational studies, and Real World Evidence projects including document preparation, statistical analysis, sample size calculation, and study design.
Clinical, statistical and methodological consulting services for the development of new technologies
Consulting services for dermocosmetic, nutraceuticals, food supplements, medical and diagnostic devices, and drugs development.
Quality System Management and CE Marking Support for Medical Devices
PRINEOS provides effective and competent support for the management of Quality Systems (ISO 13485, 21CFR820, MDSAP) and for the CE marking of medical devices under Regulation MDR 2017/745 and IVDR 2017/746.
Quality Management System 406
A quality management system based on ISO requirements, designed and implemented by PRINEOS to ensure effective operation and control, availability of resources, and support for their implementation and monitoring.
Regulatory Affairs & Quality Management
Comprehensive regulatory affairs support through all stages of a product’s lifecycle including preclinical assessment, clinical trials, CE marking, and post-market surveillance for medical devices, in vitro diagnostic devices, drugs, and food supplements.
Regulatory Affairs & Quality Management consulting
Support for regulatory affairs and quality management including management of Quality System (ISO 13485, 21CFR820, MDSAP) and CE marking of medical devices (Regulation MDR 2017/745 and IVDR 2017/746).
Clinical, statistical
Advice for Phase I-IV clinical trials, observational studies, and Real World Evidence projects including document preparation, statistical analysis, sample size calculation, and study design.
Clinical, statistical and methodological consulting services for the development of new technologies
Consulting services for dermocosmetic, nutraceuticals, food supplements, medical and diagnostic devices, and drugs development.
Quality System Management and CE Marking Support for Medical Devices
PRINEOS provides effective and competent support for the management of Quality Systems (ISO 13485, 21CFR820, MDSAP) and for the CE marking of medical devices under Regulation MDR 2017/745 and IVDR 2017/746.
Quality Management System 406
A quality management system based on ISO requirements, designed and implemented by PRINEOS to ensure effective operation and control, availability of resources, and support for their implementation and monitoring.
Services
Management of clinical trials including planning, execution, monitoring, site and vendor coordination, and submissions to ethics committees and authorities.
Regulatory strategy, preparation of technical files and clinical evaluations, quality system support and compliance with standards (MDR/IVDR, ISO 13485, MDSAP, 21 CFR 820).
Evidence planning, medical/scientific advice, KOL engagement, advisory board support, and medical communication to optimize product value and stakeholder engagement.
Statistical design and analysis, SAP and SAP-derived outputs, sample size calculations, randomization management, and clinical data management services.
Legal consultancy including interpretation of legislation, data protection strategies and management of contractual documentation.
Patient engagement strategies to integrate the patient voice in clinical development and promote transparent access to information and participation.
Management of clinical trials including planning, execution, monitoring, site and vendor coordination, and submissions to ethics committees and authorities.
Regulatory strategy, preparation of technical files and clinical evaluations, quality system support and compliance with standards (MDR/IVDR, ISO 13485, MDSAP, 21 CFR 820).
Evidence planning, medical/scientific advice, KOL engagement, advisory board support, and medical communication to optimize product value and stakeholder engagement.
Statistical design and analysis, SAP and SAP-derived outputs, sample size calculations, randomization management, and clinical data management services.
Legal consultancy including interpretation of legislation, data protection strategies and management of contractual documentation.
Patient engagement strategies to integrate the patient voice in clinical development and promote transparent access to information and participation.
Expertise Areas
- Clinical trial management
- Biostatistics and clinical data management
- Regulatory affairs and quality management for medical devices and medicinal products
- Medical affairs and evidence generation
Key Technologies
- Artificial intelligence for site selection and recruitment
- Natural language processing (NLP) for literature and protocol support
- Clinical trial management systems
- Electronic data capture (EDC) and clinical databases