Clinical Trial – CT

General Clinical Trial questions and theories

Interventional vs. Non-Interventional

Non-Interventional Study  = Medicinal product is prescribed in the usual manner (Example: Acetaminophen only)

Interventional Study =  Participants are assigned to receive one or more interventions so that researchers can evaluate the effects of the interventions. (Study medication (Acetaminophen ) with Cantaloupe juice and Aspirin)

Top 25 disease areas

These disease areas are NOT in order.

Why Clinical Reporting Service?

Food and Drug Administration is not a Cop. Its your Mom. FDA wants to make sure you are doing the right thing.  To keep the FDA in loop, you have to keep tweeting your status periodically viz. Periodic Safety Update Report (PSUR), Developmental Safety Update Report (DSUR), SUSAR, Council for International Organizations of Medical Sciences (CIOMS), Serious Adverse-event Report, (SAR), blah..blah.

Shall we talk how to keep FDA happy. Eventually she would pay for our college fund 😉

This webpage dedicated to people who creates and submits reports for FDA. Although people who creates these listings never get to see the actual report that goes to the FDA, but these report creators are the back-bone of “Submission Group” and “Clinicians”