CLINICAL DEVELOPMENT - CRO
Clinical Development – a MedTech and IVD CRO
GBA Key2Compliance is a full-service contract research organization (CRO) that support Medical Device and In Vitro Diagnostic companies, as well as academic institutions, to design and conduct their clinical development program from start to finish.
We understand that making your medical or In Vitro Diagnostic device a success on the market is all about having the right data. Our aim is to make that journey as smooth as possible.
Quality-Centric Clinical Development Services
Our focus on quality and efficiency defines the services we provide in clinical development. Our approach is clear-cut and result-oriented, guiding every step we take. We pay close attention to the distinct needs of your project, fostering a partnership that is both proactive and practical.
Clinical Strategy
Our clinical regulatory support empowers medical device and IVD companies to develop strategies and gather the necessary data to substantiate their product claims under IVDR and MDR frameworks. We focus on clearly defining and communicating the clinical benefits of your products, ensuring they meet the stringent evidentiary requirements.
Clinical Investigation and PMCF Studies
We manage clinical investigations, clinical performance studies and post market follow-up studies, offering project management, study design and statistical analysis. Proficiency in data management and electronic Case Report Forms (eCRF) ensures that applications and submissions to Competent Authorities are handled efficiently. Monitoring is a crucial component of our services to maintain quality and compliance.
Medical Writing and Clinical Evaluations
Our medical writing and clinical evaluations expertise allows us to offer thorough planning and reporting for clinical investigations. We meticulously plan and report Post Market Surveillance Clinical Follow-ups. Our team produces detailed clinical evaluations, investigator’s brochures, informed consent documents, and scientific publications, all supporting your medical device’s documentation and approval process.
Electronic Trial Master File (eTMF) – A Clinical Investigation Documentation System
Our eTMF system is a user-friendly and cost-effective solution for managing clinical investigations. It offers streamlined, compliant documentation processes with real-time access and adaptability for both local and international work. By centralizing and digitizing documentation, our system enhances efficiency and audit readiness, leading to improved clinical outcomes.
It Is the team that makes the difference
“Our work is rooted in medical science, with a commitment to truly add genuine value. Meaning that we bring a sense of responsibility and ownership to every clinical project, always striving to be the seamless extension of the customer’s team.
Our aim is to work alongside you, using our expertise to bring medical technology from development to market with precision and care.”
Jeanette Demorney, Director Of Clinical Development
Navigating IVDR-Compliant Clinical Development
Our consulting team provides expert guidance in Clinical Development that is compliant with the In Vitro Diagnostic Regulation (IVDR). We design and conduct investigations tailored to verify your product’s safety, performance, and effectiveness. Our expertise enables you to meet the stringent requirements of IVDR, ensuring product excellence and compliance.
Teamwork with Tailor-Made Solutions
Here are some examples of how collaborations in Clinical Development with GBA Key2Compliance could look:
Want to learn more about the road to CE-mark for your medical device?
The CE mark indicates that a product meets the applicable EU laws and allows the manufacturer to make their device available on the European market. Navigate the complexities of obtaining a CE mark for your medical device with our guide.
In this guide, you will find:
- Detailed Overview: A comprehensive look at the CE marking process from initial concept to market entry.
- Regulatory Framework: Insights into the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
- Quality Management Essentials: Steps to establish and maintain a Quality Management System (QMS) that complies with EU standards.
- Practical Tips: Expert advice on navigating the certification efficiently to save time and avoid common pitfalls.
Download our guide and start your road to CE mark!
Related material
A guide to regulatory compliance
Free on-demand tutorials for start-up Medical Device companies
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