28 12, 2018

Thank you for a great 2018!

2020-08-25T16:06:40-04:00

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!2020-08-25T16:06:40-04:00
19 12, 2018

Key Expectations of Clinical Trial Operations Leaders in 2019

2021-05-20T10:55:14-04:00

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 20192021-05-20T10:55:14-04:00
24 10, 2018

Four Observations from Site Solutions Summit

2021-05-20T10:46:49-04:00

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 Summit2021-05-20T10:46:49-04:00
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
18 06, 2018

Transitioning Your CRA Team to Digital Site Management

2021-05-20T10:07:45-04:00

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 Management2021-05-20T10:07:45-04:00
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
27 03, 2018

The Impact of Remote Monitoring on CRAs | Central Monitoring Summit

2021-05-19T19:08:12-04:00

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 Summit2021-05-19T19:08:12-04:00
19 03, 2018

How to Use Electronic Signatures (eSignatures) in Clinical Trials

2021-05-19T19:00:10-04:00

Electronic signatures, eSignatures, are continuing to gain momentum replacing wet signatures in Clinical Trials. Wet signatures are signatures made by hand on a document, typically with a pen and paper, which are often later electronically scanned into a storage system or maintained on paper and stored in a binder room. Electronic Signatures, often called [...]

How to Use Electronic Signatures (eSignatures) in Clinical Trials2021-05-19T19:00:10-04:00
12 03, 2018

Cancer Research Is Accelerating, But We Can Do Better

2021-05-19T18:51:32-04:00

The rate of cancer death has been decreasing, and people are living longer with cancer than ever before. Approximately 64% of US patients diagnosed with cancer in 2005 have lived 10 years or more beyond diagnosis, up from 35% for those diagnosed in 1975. — American Society of Clinical Oncology Cancer Advances Report, 2018. [...]

Cancer Research Is Accelerating, But We Can Do Better2021-05-19T18:51:32-04:00
7 02, 2018

Innovations | The time is now for eRegulatory and eSource

2021-05-19T18:40:00-04:00

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 eSource2021-05-19T18:40:00-04:00
14 07, 2017

5 Ways To Engage Clinical Trial Sites With Technology

2021-05-19T17:49:13-04:00

As Featured in Clinical Leader, July 13 2017 Clinical research has a reputation for being notoriously slow to adopt new technologies. This should come as no surprise to those in the industry, since we operate in a highly regulated environment. We’re generally skeptical about technology for three main reasons: Potential data security and compliance [...]

5 Ways To Engage Clinical Trial Sites With Technology2021-05-19T17:49:13-04:00
30 03, 2017

Can I control access with electronic binders?

2021-05-19T17:37:27-04:00

You’ve decided to make the transition from papers to digital. Your sponsor is on board. You’ve organized your binder and folder structure templates. Now what? It’s time to configure access by setting up roles and permissions. Not sure where to start? Here’s a quick guide to managing your team digitally. Wait, I never had [...]

Can I control access with electronic binders?2021-05-19T17:37:27-04:00
6 10, 2016

4 Takeaways from the 4th Annual Embracing Change Conference for Clinical Research

2021-05-19T16:41:37-04:00

The 4th Annual Embracing Change Conference for Clinical Research was a well-produced event from Arizona State University’s Clinical Research Management program. If you did not make it and would like a copy of the Status of Paperless Trials Presentation, send Florence a short email by clicking here. A substantial portion of the conference revolved [...]

4 Takeaways from the 4th Annual Embracing Change Conference for Clinical Research2021-05-19T16:41:37-04:00
15 09, 2016

What does a modern Clinical Research Coordinator do?

2021-05-19T16:13:08-04:00

What does a modern Clinical Research Coordinator do? Clinical research coordinators (CRCs) play a crucial role in ensuring the success of research sites. Managing a myriad of responsibilities throughout the day, the Clinical Research Coordinator is the “heart” of a clinical trial – the champion of the protocol, the guardian of the patients, [...]

What does a modern Clinical Research Coordinator do?2021-05-19T16:13:08-04:00
12 07, 2016

Defining eSource for Clinical Trials: Three Practical Categories

2021-05-19T15:56:49-04:00

When discussing eSource there is as much detail to explore as any other segment of clinical trial operations. But from small biotechs to top 20 pharma, the starting point for discussions is more simple: how do we define eSource? After numerous deployments of eBinders and eBinders eSource, we've come to understand that eSource is three things. First, let's [...]

Defining eSource for Clinical Trials: Three Practical Categories2021-05-19T15:56:49-04:00
16 06, 2016

Leading Prostate Cancer Research Organization Partners with Florence

2021-05-19T14:01:08-04:00

PCCTC Collaborates with Florence Healthcare to Enhance Regulatory Document Management Capabilities ATLANTA, GA and NEW YORK, June 10, 2016 – Florence Healthcare, developer of the innovative trial site-focused electronic trial site and master file (eTMF) platform, eBinder Suite™, and the Prostate Cancer Clinical Trials Consortium (PCCTC), the nation’s leading multicenter clinical research organization specializing [...]

Leading Prostate Cancer Research Organization Partners with Florence2021-05-19T14:01:08-04:00
13 05, 2016

eSource and eCTD Guidance & Eliminating Shadow Charts: Is Now the Time?

2021-05-19T13:55:40-04:00

Shadow charts develop for various reasons in clinical research as discussed in a prior post on shadow charts.  They emerge at trial sites because of disparate IT systems: for example an EHR record may be printed onto paper for editing, redacting and signing before being rescanned into a study portal. The remaining stub is [...]

eSource and eCTD Guidance & Eliminating Shadow Charts: Is Now the Time?2021-05-19T13:55:40-04:00
24 03, 2016

Interview Series: Paperless Clinical Trials

2021-05-19T13:47:49-04:00

The views expressed in the interview are solely of the individuals involved and do not represent the views of the associated organization. Interviewer: Mike Kassin, MD, Florence Healthcare Learn more about paperless trials today. Speaker: John McAdams, Manager, Data and Safety Monitoring, UCSF Helen Diller Family Comprehensive Cancer Center ___________ With increasing site workload and protocol [...]

Interview Series: Paperless Clinical Trials2021-05-19T13:47:49-04:00
28 01, 2016

Be Audit Ready Now

2020-08-25T16:01:23-04:00

The phrase “Audit Ready” is casually tossed around as a standard practice for both sites and sponsors. When I worked as a research coordinator I went to great lengths to make sure my binders were audit ready, particularly for one study that was deemed a high risk for inspection due to the novel nature of the [...]

Be Audit Ready Now2020-08-25T16:01:23-04:00
19 01, 2016

Secure Your Records. Protect Your Research.

2021-05-19T13:36:58-04:00

With banking, stock trading, and now health records becoming electronic, what’s stopping someone from obtaining every detail about our lives? In clinical research, keeping Protected Health Information (PHI) – patients’ personal and identifiable information — secure is the key concern. Losing this means potentially harming the patient, running afoul of laws like HIPAA, and [...]

Secure Your Records. Protect Your Research.2021-05-19T13:36:58-04:00
31 08, 2015

Moving to Electronic Source: What’s in the June 2015 ICH Guidelines?

2021-05-19T13:30:14-04:00

On June 11, 2015, the International Conference on Harmonization released the draft update of Good Clinical Practice guidelines.  The addenda feature important changes affecting investigator oversight, document processes, monitoring plans, and validation (the changes will not be final until November of 2016).  Each of these pulls the tide towards further electronic management of clinical trials. With [...]

Moving to Electronic Source: What’s in the June 2015 ICH Guidelines?2021-05-19T13:30:14-04:00
3 08, 2015

Opposing Views on FDA Complete Response Letters

2021-05-19T13:13:10-04:00

Recently, the British Medical Journal published an analysis on how pharmaceutical companies publicly address Complete Response Letters (CRL) from the FDA, more specifically from the Center for Drug Evaluation and Research (CDER). While the EMA publishes data from refusal assessment reports, the FDA does not fully disclose information with CRLs because of privacy rules around unapproved [...]

Opposing Views on FDA Complete Response Letters2021-05-19T13:13:10-04:00
26 05, 2015

Risk Based, Remote, and Centralized Monitoring in Clinical Trials

2021-05-19T13:04:30-04:00

This Post Originally Published in 2017, Updated in April 2021 AfteThe Florence team just got back from the MAGI conference where we spoke on clinical trial site operational efficiency and the impact that monitoring queries have on sites. In our session and throughout the conference we heard the question: What is the difference between Risk-Based, Remote-Based, and Centralized Monitoring [...]

Risk Based, Remote, and Centralized Monitoring in Clinical Trials2021-05-19T13:04:30-04:00
21 05, 2015

Paper Shadow Charts: The Hidden Barrier to eSource

2021-05-19T12:52:19-04:00

The benefits of eSource - where trial data remains electronic from start through data lock - are well understood. They include the elimination of transcription errors (shown by Nham et al to be 10x more accurate), reduction in duplicitous effort and monitoring requirements, and easier query resolution. With clinical EHR adoption nearing 90%, digital [...]

Paper Shadow Charts: The Hidden Barrier to eSource2021-05-19T12:52:19-04:00