Insights Blog

Smart Decisions Behind a Successful FDA Inspection with eRegulatory

Posted by Abbie Hosta on Jun 26, 2018 12:30:20 PM
New Case Study Offers Insight into an FDA Inspection from a Research Site using eRegulatory 

If you find yourself standing on a railroad track, you can expect that at some point you’ll hear the distant whistle and rumble of an oncoming train. At that moment the smart decision is to step off the track in preparation of the train’s arrival.

For clinical research sites, FDA inspections are a bit like an oncoming train. They don’t whistle or rumble,  but you know they are coming. You just don’t know exactly when. The difference between getting rolled over by the inspection and surviving unscathed comes down to preparation. What are you doing to step off the tracks?

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Topics: Paperless Research Sites, Regulatory Compliance, eRegulatory, Paperless Clinical Trials, Compliance, FDA Inspections, Electronic Signatures

FDA Inspections Need Not Be Stressful: A Q&A With Dr. Harvey Arbit

Posted by Complion on Aug 2, 2016 2:07:55 PM

The following is based on a transcript of the Question and Answer portion of “FDA Inspections Need Not Be Stressful,” a Complion webcast featuring Dr. Harvey Arbit, PharmD, MBA, RAC, CCRP. Dr. Arbit is the president of Arbit Consulting, and is an adjunct professor at the University of Minnesota College of Pharmacy.

Download the feature article based on this webcast here.

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Topics: Regulatory Compliance, FDA Inspections

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Complion provides clinical research sites and their sponsors with a software platform to enable secure, compliant and efficient management of documents and administrative tasks. We would love to hear from you with any questions about our Insights blog or to learn more about our software platform.

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