Brent Sorrells, Director of Clinical Operations, Allako

6 Tips for FDA Inspection Prep

It can be the professional equivalent of sitting in your dentist’s waiting room the morning of your root canal surgery. Whether it’s unannounced or you received some notice, U.S. Food and Drug Administration (FDA) inspections can be unnerving experiences for clinical trial sponsors, to say the least. However, there are tools and tactics you can employ […]

In New Survey, Nearly 60% of Clinical Researchers Blame Data Management Hurdles for Trial Delays

Clinical Trial Data Snafus Attract Unwanted FDA Attention

Persistent clinical trial data management problems are slowing trials, sparking U.S. Food and Drug Administration (FDA) audit findings and 483s, and putting patients at risk. That’s the grim assessment of clinical researchers in a new survey report from Oracle Health Sciences and Pharma Intelligence. Nearly 60% of clinical researchers said data management hurdles had […]

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Medical Center of the Americas Foundation Joins ACRP’s Clinical Research ‘Workforce Innovation Steering Committee’

The Association of Clinical Research Professionals (ACRP) welcomes Medical Center of the Americas Foundation as the latest member of the ‘Workforce Innovation Steering Committee’ (WISC). The WISC is a collaborative partnership of private and public stakeholders working to improve clinical trial quality and respond to changes impacting the workforce by providing oversight for needed standardization […]

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Sponsors and Sites Must Find New Ways to Collaborate

There’s too much “us” versus “them” dividing sites and sponsors as they conduct clinical trials—and patients suffer the consequences, several thought leaders said during a panel discussion at the Veeva 2018 R&D Summit in Philadelphia last month. “There should be more focus on the patient as driving us to one common vision,” said Dawn Fury, […]