clinical trials

/clinical trials
24 10, 2018

Four Observations from Site Solutions Summit

2018-10-24T14:25:22+00:00

This year’s SCRS Site Solutions Summit was the biggest ever, and for good reason—sites are coming into their own in the clinical trial value chain. Not only are sites maturing their operations and sending more staff to events like SCRS to learn, but sponsors have also realized that connections with sites are more important than [...]

Four Observations from Site Solutions Summit2018-10-24T14:25:22+00:00
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
18 06, 2018

Transitioning your CRA team to Digital Site Management

2018-06-18T11:13:27+00:00

Over the last six months something interesting happened in usage data for eBinders, Florence’s eRegualtory and eSource platform, and by extension for study management in general. In April 2018 Clinical Research Associate (CRA) teams became Florence’s most active users. In fact, sponsor activity in the tool grew by nearly ten times Q4 2017 to Q1 2018. [...]

Transitioning your CRA team to Digital Site Management2018-06-18T11:13:27+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
27 03, 2018

The Impact of Remote Monitoring on CRAs | Central Monitoring Summit

2018-03-27T21:24:16+00:00

While presenting at Central Monitoring Summit 2018, Elizabeth Robinson of Horizon Pharma shared a strong data point: In the coming years, Clinical Research Associates (CRAs) will experience more change to their jobs than any other research profession (2017 Applied Clinical Trials survey). This statement spurred a conversation amongst the room about what will change [...]

The Impact of Remote Monitoring on CRAs | Central Monitoring Summit2018-03-27T21:24:16+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 Risks2018-06-18T15:25:39+00:00