Clinical Strategy & Clinical Evaluation Plan
Quality-Centric Services
Our clinical development services are defined by a commitment to quality and efficiency. We adopt a clear-cut, result-oriented approach, tailored to meet the unique needs of each project, fostering proactive and practical partnerships.
Clinical Strategy
We help medical device and IVD companies develop strategies and gather data to substantiate product claims under IVDR and MDR frameworks. Our focus is on defining and communicating the clinical benefits of your products to meet stringent evidentiary requirements.
Clinical Investigation and PMCF Studies
We manage clinical investigations, performance studies, and post-market follow-up (PMCF) studies, providing project management, study design, and statistical analysis. Our proficiency in data management and electronic Case Report Forms (eCRF) ensures efficient handling of applications and submissions to Competent Authorities. Monitoring is integral to maintaining quality and compliance.
Medical Writing and Clinical Evaluations
Our expertise in medical writing and clinical evaluations enables us to offer thorough planning and reporting for clinical investigations. We produce detailed clinical evaluations, investigator’s brochures, informed consent documents, and scientific publications to support your medical device’s documentation and approval process.
Electronic Trial Master File (eTMF)
Our eTMF system is a user-friendly, cost-effective solution for managing clinical investigations. It offers streamlined, compliant documentation processes with real-time access, adaptable for both local and international projects. Centralizing and digitizing documentation enhances efficiency and audit readiness, leading to improved clinical outcomes. Read more
The Team Makes the Difference
“Our commitment is to add genuine value through medical science. We bring responsibility and ownership to every clinical project, striving to be a seamless extension of the customer’s team. Our goal is to bring medical technology from development to market with precision and care.”
Jeanette Demorney, Director of Clinical Development
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Ready to take your medical devices to the next level? Contact us today to learn how our comprehensive MedTech solutions can support your needs.