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Bring your DocuSign, AdobeSign, etc solutions into 21CFR11 FDA compliance. The commercial versions do NOT come “pre-validated”. You must create certain SOPs, processes, tests, training and documentation to meet GCP standards.
Create a GCP compliant, clinical CRO qualification process and then remotely qualify your clinical CROs with custom checklists and forms specifically designed with service-specific questions.
Get a “pulse check” on the state of your trial’s eTMF inspection readiness.
Let us design a process for you that will meet MHRA, EMA, TGA and Singapore’s expectations.
We can develop something custom to your needs and audience with meaningful Q&A. This can also be adapted to your clinical study type and therapy area.
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