THE SERVICE
Organizing a clinical investigation is a complex and lengthy process that involves multiple phases and requires detailed planning.
Med Device Lab can provide support in the key phases of organizing a clinical investigation:
- Definition of objectives and protocol planning: Identification of study objectives and development of a detailed protocol outlining the study plan, inclusion and exclusion criteria, data collection methodology, expected number of participants, scheduled visits, and more.
- Assistance with regulatory and ethical approvals: Obtaining approval from the Ministry of Health and receiving approval from local ethics committees to ensure the study is ethical and respects participants’ rights.
- Selection of sites and healthcare facilities for the study: Identification and selection of research centers or hospitals participating in the study, and initiation of contracts and negotiations with study sites.
- Training of investigators and healthcare staff: Providing training to investigators and staff involved in the study on experimental procedures, data collection, and documentation.
- Data collection and monitoring: Initiation of data collection in accordance with the protocol and conducting periodic visits to study sites for monitoring and data quality verification.
- Assistance with data management: Implementation of a data management system to record, control, and analyze collected data. Ensuring data anonymity and protection in compliance with privacy laws, collected using dedicated and validated software.
- Data analysis: Conducting statistical analysis of collected data to evaluate primary and secondary study objectives, and producing the final report.
- Reporting of results: Preparation of a final report with study results and presentation to regulatory authorities, publication in scientific journals, or sharing with the scientific community, depending on study objectives.
- ISO 14155: Assisting sponsors in aligning the clinical investigation with the technical standard UNI EN ISO 14155:2020, providing organizational, managerial, and regulatory tools for the proper execution of clinical studies with patients, enabling the application of evidence-based medicine methods to the field of medical devices.
Organizing a clinical investigation requires careful cooperation among sponsors, investigators, research centers, and other stakeholders involved. Effective management of each phase is essential to ensure the reliability of results and the safety of study participants. Moreover, it is crucial to adhere to applicable local and international guidelines and regulations throughout the process.
WHO WE SERVE
- Medical device companies and manufacturers: Many clinical investigations are directly sponsored by companies that develop and manufacture the medical device under study.
- Research institutions or academia: In some cases, research institutes, universities, or healthcare facilities may act as sponsors for a clinical study on a medical device. These sponsors may conduct studies for academic, research purposes, or to contribute to the development of new medical technologies.
- Non-profit organizations: Some non-profit organizations, such as medical associations or research foundations, may sponsor clinical investigations on medical devices for the purpose of improving clinical practice or advancing scientific research in general.
PROJECTS - Clinical Investigations
MED FAST TRACK 2
In the second phase of Med Fast Track, support will be provided for the preliminary feasibility analysis of the clinical investigation. Documentation related to the medical device will be evaluated, and the subsequent definition of the regulatory strategy will be conducted to properly frame both pre-market and post-market clinical investigations.
PRE-MARKET CLINICAL INVESTIGATIONS
Pre-market clinical investigations related to medical devices are studies conducted to assess the effectiveness, safety, and performance of such devices. These investigations are crucial for obtaining CE marking for the medical device. The main focus of the project is to ensure proper planning and execution of the investigation and obtain all necessary regulatory approvals to […]
POST-MARKET CLINICAL INVESTIGATIONS
Post-market investigations are an integral part of ongoing surveillance on medical devices and are crucial for identifying any safety or performance issues that may arise after the approval and market introduction of a medical device.
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We are an open infrastructure aimed at supporting the creation and development of health technologies. We promote and offer multidisciplinary services, training, and updates on the processes of creation, certification, and development of medical devices. We carry out initiatives in scientific dissemination and communication, information dissemination, and spreading knowledge, scientific culture, and technology.
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