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Authors hate this and companies should respond
Where do authors spend most time that they hate. Easy guess, it’s Formatting and reviews.
In spite of process documents, templates, rule books, qc checklists, authors still spend lot of t…
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Site Wise Randomization benefits and managing with IRT
Clinical trials are essential for evidence-based medicine, providing critical insights into the efficacy and safety of new treatments. One crucial aspect of conducting clinical trials is the rando…
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Regulatory Impact Assessment; How are you handling this currently?
Regulatory Impact Assessment (RIA) need not be fully integrated into the regulatory policy processes from the beginning. Companies can start by undertaking RIA for certain key regulations which ar…
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Small/Mid-Size Firms: Take Low-tech, Low-cost Path for tech/software for your process
Too often, small and mid-size companies are intimidated by the costs, complexity, and long implementations…
It’s possible to turn RA/QA into a smart function much faster and cheaper than most…
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FDA: Software Assurance guidance for Production and Quality System Software
This draft guidance is intended to:
Computer Software Assurance is a risk-based approach to establish confidence in the automation used for production or quality systems, that software is fit …
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