Clinical Affairs

This is a place to discuss all your clinical investigation requirements and use cases.

  • 3 Topics
  • 6 Replies

3 Topics

S
Silvia RonchiNew Participant
asked in Clinical Affairs

Combined Trial

Dear all, do you have experience with combined trial (where the object of the evaluation is 2 different products: a drug and a medical device)? Are 2 different protocols required? In which way the 2 submissions are linked and how the 2 different regulatory authorities communicate the outcome of the 2 applications, do we need 2 different approvals?Thank you very much,Silvia Ronchi 

2
S
1 month ago
M
MCZNew Participant
posted in Clinical Affairs

Implantation

Hi All, We are designing our strategy to get our device to a pilot clinical trail and when discussing biocompatibility testing with an expert in the US, he told us our chronic animal study should be at least 90 days and GLP in order to meet the implantation safety requirements to get the green light for our pilot.  Does anyone has any experience that can share?Our pilot will be conducted in Europe, specifically in Germany and Italy.  And our original ideal was to do chronic implantation for 10 weeks in a non-GLP animal study, do we really need to have 90 days of implantation? Thanks!  

3
joningib
1 month ago
S
sandra.veenstraNew Participant
asked in Clinical Affairs

ISO 14155:2020 - Clinical investigation of medical devices for human subjects — Good clinical practice 

Hi everyone, I had a follow up question from the AMA last week w/ Smart Trial. One major takeaway I had was reference to the ISO standard 14155:2020 - Clinical investigation of medical devices for human subjects — Good clinical practice as the gold standard in addition to ICH-GCP. However, the standard specifically states that "[it] does not apply to in vitro diagnostic medical devices." Wondering if anyone is aware of an equivalent standard for in vitro diagnostic medical devices ? Or what standards, beyond compliance to ICH-GCP, others are adhering to.  @joningib 

1
joningib
2 months ago

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