CLINICAL DEVELOPMENT - CRO
Clinical Development
– a MedTech 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.
Your MedTech CRO – We navigate you right and fix what others can’t!
Choosing the wrong CRO for your clinical investigation (Medical Devices) or clinical performance
study (IVD) can lead to delays, compliance risks, and costly setbacks. Many companies mistakenly
turn to CROs that specialize in pharma – but MedTech is different.
- Missed deadlines? We accelerate and optimize.
- Regulatory roadblocks? We navigate them with MedTech expertise.
- Wrong CRO partner? We take over – and do it right.
MedTech and IVD studies require a different approach – and that’s our expertise.
Let our team of industry experts step in, assess the situation, and guide your study to success.
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
Insights from our Clinical experts
Åsa Testad,
Senior Clinical Data Manager
“Effective data management isn’t about collecting everything – it’s about planning what truly matters and ensuring it’s collected in a way that supports compliance and analysis.”
Emily Malmberg, Senior Consultant
“Early engagement with IVDR compliance not only ensures timely market access but also positions companies as leaders in quality and reliability.”
Anna Östblom, Clinical Project Manager
“The most rewarding moments are when we hit a tight deadline and stay on budget. But that’s also the biggest challenge.“
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:
Guide to Clinical Investigation Plans & Reports for Medical Devices
Regulatory demands for medical devices are stricter than ever. This guide helps you develop Clinical Investigation Plans (CIPs) and Reports (CIRs) that meet MDR, ISO 14155, and global regulatory standards.
What’s Inside?
- Step-by-step guidance on developing CIPs & CIRs – Learn how to structure your plans and reports for clarity and compliance.
- Key regulatory requirements & best practices – Understand MDR, ISO 14155, and what authorities expect from your documentation.
- Practical tips for study design & compliance – Get insights on risk analysis, study objectives, and essential data collection.
Download now and simplify your clinical investigation process!
Book a Free 1-Hour Consultation
with a Clinical MedTech Expert
Struggling with your clinical strategy? Let us help you get back on track.
Whether you’re dealing with delays, regulatory confusion, or uncertain study outcomes
– we’re here to help. As a dedicated MedTech CRO, we understand the specific
requirements under both MDR and IVDR.
Choose your free consultation focus:
• Clinical Evaluation – Medical Devices (MDR)
• Clinical Investigation – Medical Devices (MDR)
• Performance Evaluation – IVD (IVDR)
• Clinical Performance Study – IVD (IVDR)
• General Clinical Strategy Advice
Book a 1-on-1 session with one of our senior consultants. No cost. No pressure.
Just actionable advice based on deep regulatory and clinical expertise.
expand their reach to over 60 countries.
Related material
A guide to regulatory compliance
Free on-demand tutorials for start-up Medical Device companies
Watch tutorials>
Play recording >
Play recording >
Play recording >
Get In Touch With Our Experts
We have dedicated experts of every service of our business. Feel free to leave your contact details and we will find the right solution just for you.