Our team has extensive experience in establishing clinical proof points to grow you businessand to be compliant to the new MDR and IVDR regulations for medical devices. Our focus is to demonstrate clinical benefits over established standards.
We support medical device manufacturers in meeting the clinical and performance requirements of these regulations by designing customized clinical studies, developing post-market clinical follow-up plans, and implementing real-world data collection programs. These initiatives are directed at achieving regulatory approvals and maintaining CE Marking by generating reliable clinical evidence to ensure device safety and effectiveness.
Our in-depth knowledge of global regulatory and clinical standards enables streamlined market access and regulatory compliance, prioritizing patient safety at every stage.
We provide expert guidance in designing clinical trials that are tailored to meet your specific goals and regulatory requirements, ensuring that each study is both scientifically robust and operationally feasible.
Our team works with you from the outset to define clear objectives, select appropriate endpoints, and establish protocols that align with the highest standards in clinical research.
We support you in identifying optimal patient populations and inclusion/exclusion criteria, selecting effective control groups, and designing trials that minimize bias and maximize data reliability. With expertise in sample size calculation, randomization, and statistical planning, we help ensure that your study is adequately powered and ready to withstand regulatory scrutiny.
Additionally, we offer digital tools and comprehensive project management to streamline trial execution, monitor progress in real-time, and collect high-quality data. Our approach prioritizes efficiency and compliance, helping you achieve regulatory approvals and accelerate time-to-market for your product.
We offer comprehensive clinical writing support, helping you convey complex scientific findings clearly, accurately, and persuasively. Our experienced medical writers and clinical experts collaborate with you to produce high-quality content tailored to your audience and objectives, from white papers that distill key research insights to podium presentations that highlight significant data at conferences.
For peer-reviewed scientific articles, we assist with drafting, editing, and structuring manuscripts to meet the rigorous standards of top journals. We ensure that your findings are presented effectively, following the best practices in scientific writing and adhering to journal-specific guidelines. Our support extends through the submission and revision process, helping you address reviewer comments to maximize publication success.
Post-market clinical studies are essential for continuously monitoring the safety, performance, and real-world effectiveness of medical devices and treatments after they have entered the market. These studies provide ongoing data that help manufacturers meet regulatory requirements, maintain certifications like CE Marking, support device improvements and grow the business by highlighting the clinical benifits of your technology.
By gathering insights from real-world usage, post-market studies allow for the identification of any rare or long-term risks, ensuring patient safety over time.
We support post-market clinical studies by designing and implementing customized follow-up plans, collecting data, and providing analysis to meet regulatory standards. Our expertise ensures that your product remains compliant and performs reliably in diverse clinical environments, reinforcing its business value in the marketplace.
We love our customers, so please do not hesitate to call us!
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