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See How Our Full-Service Clinical Research Organization (CRO) Can Help Bring Your Diagnostic Device to Market
Navigating the Complex World of Clinical Research
Launching a diagnostic device requires diligent testing, regulatory approvals, and extensive research. Our full-service Clinical Research Organization (CRO) is here to guide you through every step, ensuring a smooth and efficient market entry. Partner with our experienced team and have confidence in our knowledge of intricacies within the diagnostic device landscape.
Why Our CRO Makes a Difference
In the rapidly evolving world of medical devices, having an experienced CRO by your side can be the difference between success and setbacks. Our team is equipped with the knowledge and resources to navigate challenges and expedite your device's market debut. Achieve excellence with precision and confidence.
Key Offerings of Our CRO Services
- Regulatory Experience: Our team works in tandem with you during product development to fulfill clinical and regulatory needs, confirming that your device meets the requirements for regulatory approval.
- Early Feasibility Studies: TE fast-tracks IVD device development with early feasibility study experience. Our team helps verify potential investments and validate conceptual solutions with small-scale usability and pre-clinical studies before incurring the cost of larger validation studies.
- Regulatory Pathway Consulting: TE offers the study design, protocol writing,IRB submission, subject enrollment, document preparation, and data analysis required for FDA 510(k) and CLIA Waiver submissions.
- EU & FDA Regulatory Compliance: Obtaining a CE marking in addition to a 501(k) or PMA clearance can be a daunting task. TE can help confirm that your IVD product complies with EU IVDR and FDA regulations. TE can also provide full CRO studies and act as a regulatory liaison to enable that your engineering success is also a regulatory success.
Frequently Asked Questions
How does teaming with a CRO expedite my device's market entry?
Our CRO possesses deep industry knowledge, resources, and connections that streamline regulatory approvals, testing, and other critical steps, ensuring a faster market entry.
What kind of diagnostic devices have you worked with in the past?
We've collaborated with a range of innovators, from point-of-care devices to advanced lab diagnostics systems. Our breadth of experience enables us to assist with diverse device types.
How do you confirm the quality and accuracy of clinical trials?
Our team adheres to stringent international standards, confirming robust trial design, execution, and data integrity. Quality is paramount in our approach.
Can you assist with global market entry or just specific regions?
Our experience spans multiple regions, and we can provide guidance for both global and region-specific market entries.
What's the duration of the consultation?
Our initial consultation typically lasts around 30 minutes, but this can be adjusted based on your specific needs and inquiries.
