Pooja Khemchandani joins Happy Biotech to share her journey from dentistry in India to TMF leadership in biotech. She breaks down what TMF health really means, how sponsor-side work differs from CROs, why the industry struggles with adopting new tech, and how automation and AI could reshape documentation. She also drops a spooky TMF story (yes—menus and hand scans happen) and reminds us of the ultimate rule: if it’s not documented, it doesn’t exist.
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Pooja Khemchandani joins Happy Biotech to share her journey from dentistry in India to TMF leadership in biotech. She breaks down what TMF health really means, how sponsor-side work differs from CROs, why the industry struggles with adopting new tech, and how automation and AI could reshape documentation. She also drops a spooky TMF story (yes—menus and hand scans happen) and reminds us of the ultimate rule: if it’s not documented, it doesn’t exist.
ICF: The Most Important Thing You’ll Never Read Twice
Happy Biotech
28 minutes 59 seconds
1 month ago
ICF: The Most Important Thing You’ll Never Read Twice
Micah and Suus unpack the informed consent form—what it is, why it exists, and how IRBs/ECs shape it—plus the new plain-language summary trend, vulnerable-population rules, translations, and version updates when protocols or safety data change. Short, readable, and actually useful… unlike most fine print.
Happy Biotech
Pooja Khemchandani joins Happy Biotech to share her journey from dentistry in India to TMF leadership in biotech. She breaks down what TMF health really means, how sponsor-side work differs from CROs, why the industry struggles with adopting new tech, and how automation and AI could reshape documentation. She also drops a spooky TMF story (yes—menus and hand scans happen) and reminds us of the ultimate rule: if it’s not documented, it doesn’t exist.
