Kiri

Dear members of Health Board,

I would like to contact you from the IQVIA MedTech CRO, as an authorized Clinical Performance Study (CPS) applicant for the Sponsor. We plan to submit to your assessment an initial request for authorization of an interventional CPS with a CE-marked IVD Companion Diagnostic (regulatory pathway in accordance with IVDR Art. 58.1). Please note that CPS will be submitted as a part of combined study with a pharmaceutical trial; however, IQVIA MedTech will only be responsible for the submission of the device study.

I would like to ask you about the submission requirements:

1. How the submission should be performed? Via email to [email protected]?

2. How should we proceed with the payment? Additionally, could you please confirm the following fees:

• professional evaluation: 1457 EUR for studies involving CDx, except for the performance studies involving CDx where only residues of samples are used   , 

• expert opinion: 200 EUR/h – invoiced within 10 days from the receipt of expert opinion.

3. What are the timelines to validate the submission, review the study and give the decision? Also, what are the timelines for the Sponsor in case of comments?

4. Besides the ICF, are there any other documents required in Estonian? Addtionally, is the ICF required in Russian as well?

5. Are there any additional considerations to take into account for the application for a study combined with a pharmaceutical trial?

I would appreciate your prompt response to my email at your earliest convenience.

Kind regards,

Amira Podolak, Ph.D.

Sr. Regulatory & Start-Up Specialist

IQVIA MedTech, Clinical Operations

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