CFR 21 Part 11

/CFR 21 Part 11
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 Them 2018-06-19T22:31:47+00:00
19 03, 2018

[Infographic] Launching eSignatures in Clinical Trials while Avoiding Part 11 Risks

2018-06-18T15:25:39+00:00

Electronic signatures, eSignatures, are continuing to gain momentum in the clinical trial landscape. The immediate benefits of eSignatures are clear -  your team can eliminate the printing of most regulatory documents, chasing signers, and scanning and faxing files.However, recent advances in purpose-built solutions employ eSignatures for far more than these basic benefits. Solutions in eRegulatory [...]

[Infographic] Launching eSignatures in Clinical Trials while Avoiding Part 11 Risks 2018-06-18T15:25:39+00:00
7 02, 2018

Innovations | The time is now for eRegulatory and eSource

2018-04-06T22:30:42+00:00

Innovation matters in Clinical Research… The adoption of new technology, in any industry, follows a familiar cycle outlined by Geoffrey Moore in his book Crossing the Chasm, Innovators: Innovators are the first individuals to adopt an innovation. These individuals/teams are willing to take a risk to help advance a solution. Early Adopters: These are the [...]

Innovations | The time is now for eRegulatory and eSource 2018-04-06T22:30:42+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