Good Clinical Practice

/Good Clinical Practice
2 07, 2018

Nontransferable Obligations: Why Sponsors Fail Inspections

2018-07-02T11:18:16+00:00

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 Inspections2018-07-02T11:18:16+00:00
13 06, 2018

Top 5 Trial Site FDA Inspection Failures, And How to Avoid Them

2018-06-19T22:31:47+00:00

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. [...]

Top 5 Trial Site FDA Inspection Failures, And How to Avoid Them2018-06-19T22:31:47+00:00
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 [...]

What if I get audited?2017-07-14T15:45:24+00:00
15 12, 2016

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

2018-01-09T15:09:55+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. [...]

“My PIs are super busy and unable to try new things! How can I convince them to try eBinders?”2018-01-09T15:09:55+00:00