Schedule Your Free, No Obligation Clinical Study Consultation by October 31st

Understanding the nuances and requirements of diagnostic studies (and how they differ from pharma and medical device studies) is critical. TE specializes in clinical studies for IVDs for home use, point of care, and laboratory use.

• Tailored Recommendations: Specific to your device's requirements.

• Save Time & Money: Avoid costly mistakes and wasted resources.

• Access to Industry Experts: Leverage our years of experience.

• Setting the Stage for a Successful Regulatory Submission: 510(k), dual CLIA waiver submission, De Novo, EUA, etc…No matter your goal, we have the extensive experience 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 efficiently. Regardless of whether your primary goal is obtaining FDA clearance/approval or compliance with the EU IVDR, we can assist.
   

Question 1 - Why is the consultation free?

Answer - We believe in providing value first. We're confident in our experience and want to showcase how we can help before any financial commitment.

Question 2 - How long is the consultation session?

Answer - The session typically lasts about 30-60 minutes, but we're flexible based on your needs.

Question 3 - Do I need to prepare anything for the consultation?

Answer - Just have details about your clinical study handy. The more we know, the better we can assist.

Question 4 - What if I already have a CRO provider?

Answer - No problem! We can review your current setup and suggest any improvements or alternatives.

Question 5 - Are there any obligations post-consultation?

Answer - Absolutely none. Our goal is to provide guidance. Any further steps are entirely up to you.