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About Angela Gill Nelms

Angela brings 10+ years of clinical research experience in over 50 trials partnered with more than 60 US hospitals. She also holds the title of IRONMAN Certified Coach with six completed IRONMAN triathlons under her belt. Emory, Medtronic, BS in Biomedical Engineering from Georgia Institute of Technology
19 12, 2016

What if I get audited?

2017-07-14T15:45:24+00:00

A common question many teams ask as they face the transition to digital study documents is, “What if I get audited?” Inspections evoke fear because negative audit findings significantly impact everyone. Areas of high risk include missing documents, accurate delegation of authority logs, reporting delays, and inadequate monitoring or PI oversight. Given these risks, some [...]

15 12, 2016

“My PIs are super busy and unable to try new things! How can I convince them to try eBinders?”

2016-12-15T14:13:29+00:00

Research protocol complexity is increasing and trial volumes are growing. The result - sites are struggling to take on more with the same team. Physicians and research teams are overwhelmed with cumbersome documentation and oversight requirements spread out across multiple locations. Workload imbalance and audit risk anxiety has led to turnover – exacerbating the problem. [...]

28 01, 2016

Be Audit Ready Now

2017-06-11T17:36:53+00:00

The phrase “Audit Ready” is casually tossed around as a standard practice for both sites and sponsors. When I worked as a research coordinator I went to great lengths to make sure my binders were audit ready, particularly for one study that was deemed a high risk for inspection due to the novel nature of the product [...]