Regulatory Affairs

Start Up Phase Support:

Essential documents customization for the sites
Ensure documents are up to date, preparation of updates before expiration dates (CV, MLs, IATAs, HSP)
IRB interactions: initial submission

Regulatory - Study Ongoing:

Essential Regulatory Documents maintenance: staff documents, site documents (calibration certificates)
eTMF maintenance: Site Vault TMF suggested.
IRB interactions: continuing report submission and close out submission.
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