Once your clinical investigation is underway, the focus shifts from planning and preparation to execution, oversight, and data integrity. This stage is where the evidence needed for MDR (EU 2017/745) compliance—and ultimately market approval—is gathered, validated, and documented.
At MDS, our Clinical Research Organization (CRO) services are built to manage the operational demands of ongoing studies while safeguarding compliance, quality, and timelines.
Ongoing Monitoring: Keeping the Investigation on Track
A well-designed study can still face setbacks if execution isn’t closely monitored. Our Clinical Research Associates (CRAs) conduct risk-based monitoring tailored to your protocol, study design, and regulatory requirements.
This means frequent site communication, data verification, and on-site or remote visits to ensure that every procedure aligns with the Clinical Investigation Plan (CIP) and Good Clinical Practice (GCP) standards. Issues are identified early, so corrective actions can be taken without derailing progress.
Data Management: Turning Raw Results into Regulatory Evidence
Accurate, complete, and well-documented data is the cornerstone of your technical file. We provide digital tools and secure electronic Case Report Forms (eCRFs) to streamline data collection and minimize errors.
Our team reviews and cleans data throughout the study, ensuring that the final dataset is reliable and ready for analysis. This approach not only satisfies regulators but also strengthens the scientific validity of your findings.
Regulatory Reporting: Meeting Obligations Without Delay
When the investigation concludes, we compile the Clinical Investigation Report (CIR)—a detailed record of methodology, results, and interpretation. This report is formatted and documented to meet MDR and ISO 14155 requirements, ready for submission to notified bodies or national competent authorities.
We also update your Clinical Evaluation Report (CER) with the new evidence, ensuring ongoing compliance and supporting your post-market strategy.
Post-Trial Support: Beyond the Final Report
MDR compliance doesn’t end when the trial does. Our services extend to post-market follow-up (PMCF), quality system integration, and preparation for future audits or regulatory submissions. Whether you’re expanding into new markets, planning further studies, or responding to notified body feedback, we remain your long-term partner.
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From first patient to final submission, we keep your clinical investigation running smoothly and your evidence ready for scrutiny. With MDS as your CRO partner, you gain the operational discipline, regulatory expertise, and scientific rigor needed to reach market approval with confidence.
To learn more about how our services can support your device compliance, contact us at sales@mdsfinland.com or schedule a consultation via Book a Meeting.
