Kara Jagger-Miller
2025 年 2 月 19 日
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Associate Principal Regulatory Writer
Kara is a regulatory writing professional who has over 25 years of experience in the pharmaceutical industry. With a background in analytical techniques, such as wet chemistry, data review, and analytical method validations, she is familiar with good manufacturing practice and quality assurance methods. Kara now provides regulatory writing and consulting services, in addition to leading project teams.
This blog was originally published on 2021 年 9 月 24 日, and was updated on 2025 年 2 月 19 日.
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常见问题解答
What is an Investigator’s Brochure (IB) and why is it important?
An Investigator’s Brochure is a critical regulatory document that provides clinical investigators and regulatory agencies with a comprehensive summary of clinical and nonclinical data about an investigational drug. It supports ethical trial conduct, informs investigator decision-making, and is required for regulatory compliance in clinical research.
How does improved IB management reduce regulatory risk?
By centralizing oversight, standardizing workflows, and tracking progress in real-time, companies can identify potential issues early, address them proactively, and meet submission deadlines with greater confidence, reducing the chance of regulatory delays.
How does improved Investigator's Brochure (IB) management reduce regulatory risk?
By centralizing oversight, standardizing workflows, and tracking progress in real-time, companies can identify potential issues early, address them proactively, and meet submission deadlines with greater confidence, reducing the chance of regulatory delays.