Clinical Studies for Medical Devices
Sourcia offers support in the development of your medical device from Class I to Class III, to bring your device to the market in an effective and safe way.
Sourcia can support within the complete product lifecycle process by providing the following services:
- Clinical Strategy Development: by documenting clinical and scientific benchmark of product performance and supporting data for competitors and recent product filings in the related area(s); by identifying the right regulatory guidelines or rulings that will impact expectations for upcoming trials; and by evaluating various trial design options and prioritising the options by comparing the duration and the costs of the development programs.
- Study startup & Regulatory Affairs Management: by identifying startup risks and contingencies, preparing study related documents and submissions to the Competent Authority and Ethics Committee, and conducting the site contracting;
- Recruitment & Retention: by performing site training during site initiation visits and monitor & manage the roles and responsibilities throughout the clinical study;
- Project Management: by assuring study and protocol compliance, by managing budgets & timelines, communication & mitigation plans, performing risk assessments, and managing collaborations with third parties;
- Monitoring: by performing and monitoring site initiation visits, interim monitoring visits, and close out visits. Monitors can be provided in every country throughout Europe;
- Electronic Trial Master File (eTMF) setup and Management: by setting up and maintaining eTMFs, measure multiple quality controls, preparing for archiving, and giving access to SharePoint;
- Safety Management: by setting up safety management plans, handle safety reporting, reconciliate SAEs, perform regulatory reporting, setting up safety databases and performing annual safety reporting;
- Quality Management: by performing trainings, audits and inspections.
- Market approval: by supporting the scientific and competent regulatory process to evaluate the safety and effectiveness of your development program.
- Post-marketing support: by supporting post-market surveillance studies.
As of May 26th 2020, the European Medical Device Regulation (EU) 2017/745 (MDR) was planned to come into effect. The MDR brings new rules for submission, review and conduct of clinical investigations with medical devices. Due to the COVID-19 situation the MDR has been postponed and is planned to be effective in 2021.
Sourcia has specialized teams in place to execute your medical device study on a high level of quality to gain clinical and commercial success. Regulatory experts at Sourcia provide guidance and support with regulatory strategies and pathways to market, taken the new MDR guidelines into account.