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27 03, 2019

ALCOA-C in Clinical Trial Electronic Document Management

2023-05-03T21:59:17-04:00

Good documentation is vital to good clinical research. As the saying goes, “If it isn’t documented, it doesn’t exist”. In fact, one of the most common inspection findings in investigator site inspections is the lack of reliable, accurate, and adequate source documentation. Failure to maintain adequate and accurate case histories that record all observations [...]

ALCOA-C in Clinical Trial Electronic Document Management2023-05-03T21:59:17-04:00
2 07, 2018

Nontransferable Obligations: Why Sponsors Fail Inspections

2021-05-20T10:13:16-04:00

Part 1: Lack of Oversight Discussion of FDA inspections, whether for cause or part of a routine GCP inspection, usually centers on the inspection of trial sites and the CROs who are tasked with managing them. The reason for the disproportionate focus on the inspection of trial sites and CROs stems from two material [...]

Nontransferable Obligations: Why Sponsors Fail Inspections2021-05-20T10:13:16-04:00
13 06, 2018

How to Avoid the Top 5 Clinical Trial FDA Inspection Failures

2021-05-20T10:00:32-04:00

Your heart begins beating faster and sweat begins forming on your forehead - the FDA is calling. Many things can trigger an FDA inspection - most falling into routine study-related visits, while some are "for cause," stemming from complaints or sponsor concerns. Sites that have a new drug application will most likely experience an FDA inspection. [...]

How to Avoid the Top 5 Clinical Trial FDA Inspection Failures2021-05-20T10:00:32-04:00
19 12, 2016

What if I get audited?

2021-05-19T16:56:56-04:00

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 [...]

What if I get audited?2021-05-19T16:56:56-04:00
15 12, 2016

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

2021-05-19T16:50:18-04:00

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 [...]

“My PIs are super busy and unable to try new things! How can I convince them to try eBinders?”2021-05-19T16:50:18-04:00