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28 12, 2018

Thank you for a great 2018!

2019-08-02T15:47:21-04:00

What a great year at Florence! As we look back and celebrate all that has happened this year on our mission to advance research, we thank you for being a part of the Florence family. We are excited to share some of our highlights with you. Over 2,500 Research Teams added in 2018! Research [...]

Thank you for a great 2018!2019-08-02T15:47:21-04:00
19 12, 2018

Key Expectations of Clinical Trial Operations Leaders in 2019

2019-08-02T15:47:54-04:00

Today’s clinical trial operations leaders are in a challenging and expanding role. You are expected to increase study capacity, manage more complex trial protocols, accelerate study startup, and ensure timely sponsor collaboration - all while remaining hamstrung by limited resources, siloed data, stronger regulations, changing sponsor demands, and a growing site footprint. Clinical [...]

Key Expectations of Clinical Trial Operations Leaders in 20192019-08-02T15:47:54-04:00
24 10, 2018

Four Observations from Site Solutions Summit

2019-08-02T15:50:12-04:00

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 [...]

Four Observations from Site Solutions Summit2019-08-02T15:50:12-04:00
2 07, 2018

Nontransferable Obligations: Why Sponsors Fail Inspections

2019-08-02T15:55:31-04:00

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 Inspections2019-08-02T15:55:31-04:00
18 06, 2018

Transitioning your CRA team to Digital Site Management

2019-08-02T15:56:04-04:00

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 Management2019-08-02T15:56:04-04:00
13 06, 2018

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

2019-08-02T15:56:47-04:00

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. [...]

Top 5 Trial Site FDA Inspection Failures, And How to Avoid Them2019-08-02T15:56:47-04:00
27 03, 2018

The Impact of Remote Monitoring on CRAs | Central Monitoring Summit

2019-08-02T16:02:50-04:00

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 Summit2019-08-02T16:02:50-04:00