Product Ideas

Redactions and compliance with various organizations and standards groups - Clinical Trials

As a consumer of the PrizmDoc Redaction API, I may be building applications that require my systems to comply or I cannot sell them into that vertical. In this case, the vertical is Clinical Trials.  Here are the regulatory authorities in play:

  •  US FDA
  • EMA (Policies 0070 and 0043)
  • Health Canada 
    Pharmaceutical and Medical Devices Agency (Japan)
  • China Food and Drug Administration
  • TGA 

I can share the prospect email that I received from Paul V asking 'can we do this'. Briefly, the prospect was looking "To identify suppliers that offer clinical trial redaction and disclosure services in compliance with regulatory authorities in the US, Europe, Asia, and Latin America"

I let Paul know that we are not a supplier, but it made me think that perhaps there is something beneficial if we could know what is needed and if PrizmDoc could be compliant in 3rd party applications.

Thanks!

Brandon

  • Brandon Mount
  • Aug 22 2019
  • Attach files