CLINICAL DEVELOPMENT - CRO

Clinical Development – a MedTech and IVD CRO

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.

Medical Device Clinical development CRO

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.  

A full service CRO,Clinical evaluation, Performance evaluation, Project management, Clinical investigations, Clinical performance studies, Clinical strategy, Post market follow-up studies Medical writing, Biostatistics, Data management, Monitoring

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

Jeanette Demorney

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 Key2Compliance could look:

A CE-marked class IIa product under the Medical Device Directive (MDD) required support with both biological and clinical evaluation for recertification.
Collaborating closely with the product manager and the clinician/inventor, all documents were prepared within 3 months and approved by the Notified Body without any queries.
For a class II product undergoing CE marking, the customer sought to strengthen safety data through an investigation conducted by Key2Compliance at three sites in Sweden.
We were responsible for project management, monitoring, data management, and documentation support.
Following a response from the Notified Body regarding the Clinical Evaluation Report (CER) for a CE-marked software product, which included a lengthy list of queries to be addressed within 3 weeks, Key2Compliance revised the Clinical Evaluation Plan and Report with a new strategy and stronger arguments.
The response was submitted to the Notified Body on time.
For a class I product under development, Key2Compliance provided 6 months of support. The clinical evaluation was partly based on a similar product and literature search.
The new CE marking was achieved with only one clarification needed, without revision of the Clinical Evaluation Plan (CEP) and CER.
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Case #1
A CE-marked class IIa product under the Medical Device Directive (MDD) required support with both biological and clinical evaluation for recertification.
Collaborating closely with the product manager and the clinician/inventor, all documents were prepared within 3 months and approved by the Notified Body without any queries.
Case #2
For a class II product undergoing CE marking, the customer sought to strengthen safety data through an investigation conducted by Key2Compliance at three sites in Sweden.
We were responsible for project management, monitoring, data management, and documentation support.
Case #3
Following a response from the Notified Body regarding the Clinical Evaluation Report (CER) for a CE-marked software product, which included a lengthy list of queries to be addressed within 3 weeks, Key2Compliance revised the Clinical Evaluation Plan and Report with a new strategy and stronger arguments.
The response was submitted to the Notified Body on time.
Case #4
For a class I product under development, Key2Compliance provided 6 months of support. The clinical evaluation was partly based on a similar product and literature search.
The new CE marking was achieved with only one clarification needed, without revision of the Clinical Evaluation Plan (CEP) and CER.
Previous slide
Next slide

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