Steve Sibley, Author at Certara

Diving into Best Practices for Pooling Clinical Trial Data

2016年6月3日

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 … Continued

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

2015年10月6日

By Steve Sibley

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, … Continued

Author: Steve Sibley