Full Service IVD Clinical Research Organization (CRO)
Understanding the nuances and requirements of diagnostic studies (and how they differ from pharma studies) is critical to ensuring a successful outcome of your study. TE´s specializes in clinical studies for IVD consumables, instruments and other products.
We Support a Variety of IVD Clinical Performance Studies
For years, we have supported numerous manufacturers – from startups to multinationals – with IVD studies for a variety of diagnostic devices. As a full service CRO, we assist with all aspects of clinical study planning, study design, protocol development, IRB/Ethics submission/approval, study execution, data management, report writing .
We Support a Variety of IVD Clinical Performance Studies, For years, we have supported numerous manufacturers – from startups to multinationals – with IVD studies for a variety of diagnostic devices. As a full service CRO, we assist with all aspects of clinical study planning, study design, protocol development, IRB/Ethics submission/approval, study execution, data management, report writing .
Full CRO Capabilities
TE is fully equipped and qualified to handle the following types of observational and interventional clinical studies.
- Project management from conception to completion
- Study design and protocol writing
- Site and laboratory identification, qualification, selection and management
- Site start-up, monitoring and closeout
- Electronic trial master file (eTMF) creation and management
- Electronic data capture (EDC) design and build
- Customized data dashboard with daily updates throughout the study
- Statistical planning, data management and analysis
- Supply management
- Clinical studies to support IVDR
- Dual Submissions
- Emergency Use Authorizations
- 510(k) Submissions
- DeNovo Submissions
We Shorten Your Path to Commercialization
TE offers diagnostic companies a single solution for product development, usability testing and, clinical studies. Regardless of whether you choose to work with us on development, our 100% focus on IVDs means we understand the sample sizes and endpoints needed to bring a study to a successful conclusion, and do so in the most cost-efficient and effective manner possible.
Setting the Stage for a Successful Regulatory Submission
510(k), Dual Submission, De Novo, EUA No matter your goal, we have the expertise to help you get there. As IVD specialists, we understand the specific requirements of FDA guidance and international standards such as ISO 20916. This allows us to design and execute your study in the most efficient manner possible. Regardless of whether your primary goal is obtaining FDA clearance/approval or compliance with the EU IVDR, we can assist.
Our Network Includes More Than 350 Clinical Trial Sites
TE Connectivity has 350+ sites established throughout the United States ranging from point-of-care offices, urgent cares, emergency rooms, research only sites and reference labs.
