Certara’s Best of Blogs 2015

A selection of short essays from our blog, written to empower our customers with biosimulation and regulatory writing solutions in order to help them solve the toughest drug development problems. Certara staff contributions range in topic from pharmacometrics to systems biology to the growing importance of regulatory writing.

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Diving into Best Practices for Pooling Clinical Trial Data

Steve Sibley

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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Topics: PK/PD Modeling and Simulation, Regulatory Writing

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

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, they have no idea what an elephant is. So, they decide to go and touch it. The blind men describe what they feel as the following:

Hey, the elephant is a pillar,” said the first man who touched his leg.

“Oh, no! It is like a rope,” said the second man who touched the tail.

“Oh, no! It is like a thick branch of a tree,” said the third man who touched the trunk of the elephant.

“It is like a big hand fan” said the fourth man who touched the ear of the elephant.

“It is like a huge wall,” said the fifth man who touched the belly of the elephant.

“It is like a solid pipe,” Said the sixth man who touched the tusk of the elephant.

They began to argue about the elephant, and every one of them insisted that he was right. A wise man was passing by and he saw this. He stopped and asked them, “What is the matter?” They said, “We cannot agree to what the elephant is like.” Each one of them told what he thought the elephant was like. The wise man explained to them, “You are all correct. Every one of you is telling it differently because you each touched a different part of the elephant. So, actually, the elephant has all those features that you all said.”

My clients are bright, talented individuals. They are committed to bringing innovative new therapies to patients. But, working in silos means that they do not have perspective on the entire process. A full service regulatory writing team can help them increase their efficiency and profitability.

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Topics: Regulatory Writing
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