Building a Compliant Clinical Investigation from the Ground Up
Before a clinical investigation can begin, several critical elements must be in place to ensure regulatory compliance, data quality, and patient safety. Under MDR (EU 2017/745) and ISO 14155, the processes of site selection, regulatory approvals, and ongoing monitoring are essential components of any clinical trial. As a trusted Contract Research Organization (CRO), MDS helps medical device manufacturers manage these foundational steps with expertise and precision.
Choosing the Right Study Site and Investigator
Selecting a qualified clinical site and an experienced principal investigator can significantly impact the success of your investigation. The right site will have access to the target patient population, infrastructure to support the study, and a team familiar with Good Clinical Practice (GCP). MDS evaluates potential sites based on both scientific and operational criteria, ensuring alignment with your Clinical Investigation Plan (CIP) and overall trial objectives.
Submissions to Regulatory Authorities and Ethics Committees
Before a trial begins, several key documents—including the CIP, Investigator’s Brochure (IB), and Informed Consent Form (ICF)—must be submitted to the relevant regulatory authorities and ethics committees. These submissions are essential for demonstrating that the study is ethically sound and scientifically justified. Review timelines vary by country, and delays can occur if documentation is incomplete or non-compliant. MDS manages this submission process to ensure timely and accurate review.
Site Permits, Agreements, and Readiness
Beyond regulatory approvals, trial sites must secure permits and contractual agreements that define responsibilities, budgets, and timelines. MDS coordinates this process, facilitating legal and administrative readiness so that your study can launch without delay. We ensure that all site-level obligations are met before patient recruitment begins.
Monitoring for Quality and Compliance
Once the trial is underway, ongoing monitoring is crucial. Our Clinical Research Associates (CRAs) visit sites regularly to verify that the study is being conducted in accordance with the CIP, GCP, and applicable regulatory requirements. Monitoring activities include reviewing source data, ensuring protocol adherence, and identifying issues before they affect trial integrity.
We also implement risk-based monitoring strategies, adapting the frequency and intensity of monitoring based on the complexity and risk profile of your investigation. This approach ensures efficient oversight without compromising quality.
Your CRO Partner for Operational Excellence
By managing site selection, submission processes, and monitoring activities, MDS ensures your clinical investigation is built on a foundation of compliance and operational readiness. With our support, you can focus on your innovation while we handle the logistical and regulatory complexities.
In our next post
We’ll examine reporting and post-trial activities, including final study reporting, documentation management, and clinical evaluation updates.