Sensible SEND – Supporting Smart People with Smart Science

Read the latest blog from Marc Ellison, Director, SEND Solutions, Instem.

I often tell people that I work in the world’s most risk-averse industry. An industry that only exists to identify risks in new pharmaceuticals and chemicals. And I love it.

Why? Because I get to work with the smartest, most dedicated individuals who are driven to make the world a healthier and safer place.

I work with great scientists. People who seek unbiased, evidence based, peer reviewed scientific truth. I get to help render their data in a standardized format so it can have a similarly unbiased, independent review by the regulator.

As any regular reader of this blog will know, for the past 12 years I have devoted my career to help define and implement data standards for pharmaceutical safety data so that regulators like the FDA are able to complete a more thorough review. After all, we are usually talking about the safety of vulnerable patients on clinical trials who are putting their bodies on the line and pinning their hopes on this new drug. For the few nonclinical studies that occur in parallel with the human clinical trials, we are testing drugs that are potentially about to go to market and be released on the wider public.

Everyone in our industry takes this responsibility seriously. We have a moral obligation to get this right. To do this right. To make the right decisions about patient safety.  That’s what SEND is all about: enabling independent, unbiased reviews to understand safety implications better.

So, I get to work with people who are both extremely smart and doing a job to help humanity.  These people are not cavalier or rash. Their decisions are based on scientific evidence. Not conspiracy theories, or crackpot ideas. No hearsay. No one here is taking risks with our children’s safety. Nobody takes their responsibility lightly.

I’m privileged to work with these great people across big pharma, biotechs, contract labs, my company, and even competitor organizations. All good people practicing good science with good motivations for presenting good data.

I don’t get to say it often enough, so this post is a thank you and an acknowledgement of the great, unsung heroes that work to ensure that, should we get sick and need medication, it won’t do us harm.

‘til next time

Marc

This blog was previously featured on Sensible SEND which is being migrated here to our new site.

Marc Ellison

Marc Ellison is the Director of SEND Solutions at Instem and has been a CDISC volunteer for 12 years. He has 3 decades of experience creating nonclinical software and working with researchers on how to best collect and organize their data. Marc refers to himself as a “SEND nerd” and is truly passionate about the concepts, debates, and evolutions around the SEND standard. Being a strong advocate for the importance of SEND in accelerating research, Marc launched his own educational blog at Instem called “Sensible SEND” to help educate and prepare researchers with cutting-edge details and explanations about the ever-developing process.

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