Completing the Clinical Investigation with Confidence
A clinical investigation doesn’t end when the last patient completes the study. The final phase—reporting and post-trial activities—is just as critical as planning and execution. This phase ensures your study meets all regulatory expectations, provides meaningful conclusions about your device’s safety and performance, and sets the stage for further development or market entry. At MDS, we guide manufacturers through every post-trial requirement, delivering reliable results and regulatory compliance.
Clinical Investigation Reporting and Data Analysis
Once the trial is completed, all data must be collected, reviewed, and analyzed. These findings are compiled into a Clinical Investigation Report (CIR), a comprehensive document that outlines the study’s objectives, design, methodology, and results. The CIR must meet the formatting and content requirements set forth by MDR (EU 2017/745) and ISO 14155, as well as the expectations of regulatory authorities and ethics committees. At MDS, we ensure your report reflects both scientific rigor and regulatory compliance.
Updating the Clinical Evaluation
The results of your clinical investigation play a key role in updating your device’s Clinical Evaluation Report (CER). This updated evaluation incorporates new safety and performance data, strengthening your overall regulatory submission and supporting your ongoing conformity assessment under MDR. Our team assists in integrating the clinical investigation results into your broader clinical evidence portfolio.
Documentation and Data Management
Efficient documentation management is essential during and after a clinical investigation. All trial-related documents must be archived in a way that ensures traceability, confidentiality, and regulatory readiness. MDS supports clients by maintaining a compliant document archive that meets ISO 14155 standards, safeguarding your records for future audits, inspections, or submissions.
Why Post-Trial Activities Matter
Post-trial reporting is more than a regulatory obligation—it provides a window into the real-world performance of your medical device. The insights gained from the trial can inform product development, future clinical strategy, and even post-market surveillance planning. By managing this final phase with care, you ensure your device continues on a solid path toward commercialization.
Partner with MDS for Complete Clinical Support
At MDS, we manage the full lifecycle of your clinical investigation—from planning and execution to reporting and post-trial documentation. Our CRO services are designed to streamline your regulatory journey and position your device for success in the global market.
To learn more about how we can support your post-trial activities or to begin planning your next study, contact us at sales@mdsfinland.com or schedule a consultation here!
