PK/PD Modeling and Simulation – A Brief Overview and Upcoming Blog Series

The year I graduated from college was the same year an old family friend was retiring. He had spent the majority of his career designing and deploying farm equipment across the United States. When I asked for advice as I entered the workforce he told me a story.

Three months into retirement, a company in California asked him to fly out and consult with their mechanics on why a piece of equipment wasn’t working. He flew out, spent 5 minutes at the company’s site, drew an “X” in chalk on the equipment, and flew home.  They called the next day and asked what they needed to do. He directed them to the “X”. As simple as an “X” is, it represented years of experience and understanding of the intricacies of the machine and what could potentially go wrong.

He said the moral of the story was, “It’s good to know where to put the X”. Continue reading

5 Things to Know About the Evolving Requirements For SEND

As our industry approaches the one year anniversary of the implementation of SEND (Standard for the Exchange of Nonclinical Data) datasets as required by the FDA for regulatory submissions, attention is shifting to the next set of requirements. From recent notices to upcoming compliance dates, we’ve compiled five key highlights for your information that will also help you proactively prepare for the changes. Continue reading

Accelerating FDA Submissions with the Trial Summary Domain

A Trial Summary (TS) domain represents an essential part of standardizing study data for electronic submissions. In July 2016, the U.S. FDA issued version 3.1 of the Study Data Technical Conformance Guide, which advised including a TS domain to identify the study start date in the submission. In clinical studies, the study start date is earliest date of informed consent from any subject enrolled in the study, whereas nonclinical studies use the study initiation (protocol finalization) date. This article reviews the importance of the study start date and makes recommendations to help ensure a successful submission for current and legacy studies.

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The Tale of a Real-life SEND Test Submission

What to Expect When Submitting Your First SEND Dataset to the FDA

SEND test submission with Covance. Photo of binary codeWith the December 17, 2016* requirement for the FDA Standard for the Exchange of Nonclinical Data (SEND*) fast-approaching, our Covance SEND action team prepared a dataset for test submission to the FDA. This helped us to better understand the FDA’s SEND submission requirements, build experience and confirm our readiness to help clients submit their SEND datasets.

During this process, we uncovered a couple of significant learnings:

  • Allow for adequate time to prepare and submit to the FDA
    • The process to deliver our first test submission took more than two months from kickoff to FDA notification
    • It’s important to start early to understand the preparation time needed for submissions
  • For test submissions only, the dataset must be submitted on a physical CD and sent to the FDA via postal mail
    • This came as a surprise to us, since SEND is a streamlined electronic format of the data
    • (Note: In a real submission, the SEND datasets will appear in a specific location labeled “tabulations” in the submission folder structure as described in section 7 of the FDA CDER/CBER Study Data Technical Conformance Guide).

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