SDTM METHODOLOGY

For SDTM mapping, Protocol and CRF will serve as the initial supporting document. Database schema along with sample data if available will aid in better understanding of the database structure which will give clarity in mapping and defining specification. Annotated CRF (aCRF) will be created against the blank CRF which will map the fields in…

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TO FSP OR NOT TO FSP….THAT IS THE QUESTION!

Apologies to William Shakespeare. In my 20 years in the Pharma / Bio industry, and in life in general, I have found that often times, its not what you say, its how you say it that matters most. Outsourcing is no different, and with it comes with its own language of relative terms. Ultimately, you…

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