The Certara Blog

Author: Steve Sibley

Steven Sibley is the Vice President of Global Submissions and Submission Leadership at Synchrogenix. With a career spanning more than 20 years in the pharmaceutical industry, Mr. Sibley has extensive regulatory and writing experience, preparing a wide variety of both nonclinical and clinical documents and leading project and submission teams.

Recent Posts

6 Signs You Need Help with Submission Planning

6 Signs You Need Help with Submission Planning

Setting and adhering to a timeline for planning, drafting, reviewing, and editing regulatory documents needed for the submission dossier is a major challenge for drug development teams. I think of this process as having three phases: “discovery, drive, and survive.” In a previous blog post, I discussed the planning that occurs in the discovery phase. […]

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Diving into Best Practices for Pooling Clinical Trial Data

Diving into Best Practices for Pooling Clinical Trial Data

If you’ve worked with a client drug development team approaching submission for approval, it’s likely you’ve heard discussions like this: Team member 1: “But, you can’t integrate the data from those studies because the treatment durations are different.” Team member 2: “That doesn’t matter, we still have to pool the results into a single integrated […]

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Is Your Approach to Regulatory Writing the Elephant in the Room?

Is Your Approach to Regulatory Writing the Elephant in the Room?

I’ve helped many clients navigate the world of regulatory writing to gain drug approvals. Our clients’ challenges remind me of the parable of the elephant and the blind men. If you’re not familiar with the story, it goes like this: A group of blind men hear that an elephant has arrived in their village. Being blind, […]

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