ClinChoice supports the management of incidents caused by medical devices. With proven experience in clinical safety management in the most complex therapeutic areas, we provide continuous support to advance patient safety. Our modular offerings permit the selection of individual services or a comprehensive end-to-end solution.
Medical Devices & Diagnostics
Incident Reporting
ClinChoice advances patient safety using our understanding of medical device nuances, industry best practices, and local regulations to provide a thorough analysis and comprehensive documentation of reported adverse incidents in compliance with the safety management plan. Our specialists excel in using safety databases such as Argus and LifeSphere Safety, enhancing our capabilities in medical device incident reporting management. We provide exceptional prowess at each stage of incident reporting management, from intake to regulatory submissions.
- Vigilant monitoring of expedited reporting and timely submission of status updates
- End-to-end operations management – triage, data entry, quality review, and medical review
- Timely and accurate submission of incident reports to health authorities/partners as applicable
- Quality management systems set up, including inline and end-of-line QC processes
- Follow up on the cases in cooperation with the study sites, including the resolution of all the technical/scientific/medical queries
- Case reconciliation between the safety and clinical databases
- Support for unblinding of studies
Medical Writing
Authoring exceptional safety reports for medical devices using small datasets from medical devices and diagnostics clinical trials needs an experienced, skilled team that looks at endpoint data, potential interactions, and other necessary information. ClinChoice’s in-house medical writers have diverse experience and proven competency in preparing reports critical to the progression of clinical trials and ongoing risk evaluation. Our understanding of the MEDDEV 2.7/1 Rev 4, MDR 2017/745, and IVDR 2017/746 regulations, GCP guidelines, relevant ISO standards, and knowledge of statistics and clinical research is key to authoring submission-worthy reports.
- Clinical Investigation Plan (CIP)
- Clinical Evaluation Plan (CEP)
- Systematic literature review protocol and report
- Investigator Brochure (IB) development
- Instructions for Use (IFU)
- Clinical investigation report
- Clinical Evaluation Report (CER)
- Summary of Safety & Clinical Performance (SSCPs)
- Risk-benefit assessment