August 28, 2018

Eliminating the Guesswork: What you need to know about Endpoint Adjudication by the CEC

Join Criterion Edge’s VP of Scientific and Medical Affairs, Kyoko Hattori for an informational webinar on Endpoint Adjudication by the Clinical Endpoints Committee.

Date/Time:  September 12th, 2018 at 11 AM PST/2 PM EST

Kyoko brings over 30 years of expertise to share with clinical field scientists and managers, drug safety specialists, medical monitors, and more. Join Kyoko and other senior professionals during the webinar to learn more about familiarization and guidance using endpoint adjudication by the CEC. (more…)

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May 30, 2018

Developing the state of the art section of the CER: challenges and pitfalls

At the 2018 MedTech Summit, on June 11 – 15 in Brussels, Belgium, Laurie Mitchell, our President, will be giving a presentation with Evidence Partners entitled: State of the Art: Best Practices and Literature Review Using DistillerSR. In this blog post, we will give you insight into some of that content, but to see the whole topic, we recommend you register for the conference, or check back on our blog in late June to download our full whitepaper. Below is a sneak peak at this topic.

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May 22, 2018

Why is it important to establish state of the art during the clinical evaluation?

At the 2018 MedTech Summit, on June 11 – 15 in Brussels, Belgium, Laurie Mitchell, our President, will be giving a presentation with Evidence Partners entitled: State of the Art: Best Practices and Literature Review Using DistillerSR. In this blog post, we will give you insight into some of that content, but to see the whole topic, we recommend you register for the conference, or check back on our blog in late June to download our full whitepaper. Below is a sneak peak at this topic. (more…)

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May 9, 2018

How has MEDDEV 2.7/1 rev 4 changed the requirements around State of the Art?

At the 2018 MedTech Summit, on June 11 – 15 in Brussels, Belgium, Laurie Mitchell, our President, will be giving a presentation with Evidence Partners entitled: State of the Art: Best Practices and Literature Review Using DistillerSR. In this blog post, we will give you insight into some of that content, but to see the whole topic, we recommend you register for the conference, or check back on our blog in late June to download our full whitepaper. Below is a sneak peak at this topic.

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May 3, 2018

Benefits of Outsourced Medical Writing

As business increases, medical device and pharmaceutical companies are finding success turning to outside vendors to meet their technical and regulatory writing needs. In doing so, these organizations gain real and specific benefits that, because of a streamlined approach, can lead to a bigger bottom line. Below are a few examples of the advantages that your company can gain by outsourcing your writing needs.

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Generis American Medical Device Summit

October 24-25, 2018

The Westin Lombard Yorktown Center
Lombard, IL 60148

 

Schedule a meeting with our President, Laurie and our CEO, Lalitha

Haven’t registered yet? Contact us to get your 65% discount code!