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About Blake Adams

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So far Blake Adams has created 44 blog entries.
30 10, 2023

4 Ways Site Enablement Platforms Support The White House’s Call for a Stronger Clinical Trial Infrastructure

2023-10-30T11:51:48-04:00

4 Ways Site Enablement Platforms Support The White House’s Call for a Stronger Clinical Trial Infrastructure The White House Office of Science and Technology Policy (OSTP)  recently announced the launch of The Clinical Trials Readiness initiative on October 26th.  This announcement highlights the need for a stronger clinical trial infrastructure to support better [...]

4 Ways Site Enablement Platforms Support The White House’s Call for a Stronger Clinical Trial Infrastructure2023-10-30T11:51:48-04:00
22 08, 2019

Why Remote Clinical Trial Monitoring is the New Standard

2023-05-03T21:55:04-04:00

Why Remote Clinical Trial Monitoring is the New Standard The COVID-19 pandemic has accelerated the ongoing shift to remote clinical trial monitoring. Remote site access and monitoring platforms are now an essential element of the clinical trial process and a vital connection between the sponsor, clinical research organization (CRO), and the research site. [...]

Why Remote Clinical Trial Monitoring is the New Standard2023-05-03T21:55:04-04:00
29 07, 2019

Overcoming Four Common Challenges in Multicenter Research

2023-05-03T21:57:47-04:00

Overcoming 4 Challenges in Multicenter Clinical Trials Efficiently managing multicenter clinical trials is an essential capability of the modern research center. Complex protocols often require diverse subjects spread across a vast network of research sites - increasing pressure on the coordinating center to streamline operations, maintain oversight, and avoid compliance risks. While the [...]

Overcoming Four Common Challenges in Multicenter Research2023-05-03T21:57:47-04:00
9 07, 2019

Integrating the eTMF and eISF: Why and Why Now?

2023-05-03T21:58:00-04:00

Best Practices for eISF and eTMF Integration Electronic Investigator Site Files (eISF) are now attracting the attention of progressive sponsors and CROs. Here, we’ll explore the different approaches and stages for connecting the site eISF directly to the sponsor Electronic Trial Master File (eTMF) and how this adjustment impacts the way clinical trials [...]

Integrating the eTMF and eISF: Why and Why Now?2023-05-03T21:58:00-04:00
26 06, 2019

Technology in Multicenter Clinical Trials

2023-05-03T21:58:23-04:00

Managing and Organizing Multicenter Clinical Trials with Technology Are you part of a multicenter clinical trial? If not, you may be soon. Multicenter clinical trials, where a sponsor or CRO relies on a highly developed coordinating center to manage a network of sites, continue to gain popularity among sponsors looking to accelerate study [...]

Technology in Multicenter Clinical Trials2023-05-03T21:58:23-04:00
22 04, 2019

FDA: Technology’s Value in a World of Precision Medicine and Research

2023-05-03T21:58:32-04:00

Over the course of the past 10 years, significant advancements have been made in clinical research. Personalized medicine, immunotherapies and genomic testing have equipped researchers with the tools necessary to identify the biological causation of diseases and to target treatments accordingly. Yet in the face of therapeutic innovation, clinical trial operations have remained old [...]

FDA: Technology’s Value in a World of Precision Medicine and Research2023-05-03T21:58:32-04:00
27 03, 2019

ALCOA-C in Clinical Trial Electronic Document Management

2023-05-03T21:59:17-04:00

Good documentation is vital to good clinical research. As the saying goes, “If it isn’t documented, it doesn’t exist”. In fact, one of the most common inspection findings in investigator site inspections is the lack of reliable, accurate, and adequate source documentation. Failure to maintain adequate and accurate case histories that record all observations [...]

ALCOA-C in Clinical Trial Electronic Document Management2023-05-03T21:59:17-04:00
12 02, 2019

5 Key Advantages of eRegulatory

2024-12-02T12:50:15-05:00

Over 75% of clinical trial sites who have not yet adopted eRegulatory plan to do so in 2019. Why? In addition to growing industry pressure from sponsors who expect a digital site infrastructure, trial sites with eRegulatory platforms are introducing key advantages over those sites without eReg. What are those advantages? Download Five Key Benefits [...]

5 Key Advantages of eRegulatory2024-12-02T12:50:15-05:00
30 01, 2019

Observations from TMF Summit 2019: The Post-eTMF World

2021-05-20T11:32:17-04:00

The Florence team just returned from the 2019 TMF Summit in Orlando, and interestingly, the core conversations throughout the conference were not really about TMFs. The innovation frontier in our industry has moved beyond core eTMF features and is now focused on the ring of activities surrounding them. What does a “Post eTMF” (or [...]

Observations from TMF Summit 2019: The Post-eTMF World2021-05-20T11:32:17-04:00
18 01, 2019

How Lauren Begnaud Transitioned 65 Sites to eRegulatory at US Oncology

2021-05-20T11:21:24-04:00

In this interview, we talked with Lauren Begnaud, Manager of Regulatory Affairs at the US Oncology Network, to discover how she successfully migrated 65 trial sites, 400 studies, and 2,000 Investigators and Support Staff to Florence eBinders for eRegulatory. Lauren has over 10 years of experience in the clinical research field and has successfully [...]

How Lauren Begnaud Transitioned 65 Sites to eRegulatory at US Oncology2021-05-20T11:21:24-04:00
28 12, 2018

Thank you for a great 2018!

2022-10-31T12:03:41-04:00

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!2022-10-31T12:03:41-04:00
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
12 09, 2018

Ten Ways Florence eBinders™ Accelerates Study Startup

2021-05-20T10:36:27-04:00

Moving to an eRegulatory/eSource solution generates measurable impact on clinical trial study startup timelines. Research teams reduce startup time by as much as 40% through harnessing the built-in features of eBinders combined with excellent standard operating procedures. Below are the top ten features more than 3,000 research teams are using to accelerate their study [...]

Ten Ways Florence eBinders™ Accelerates Study Startup2021-05-20T10:36:27-04:00
10 09, 2018

Florence Named to Top 100 Places to Work in Atlanta

2021-05-20T10:30:15-04:00

Atlanta, GA, September 10, 2018 (Newswire) - Florence, a fast-growing Atlanta based company building software that advances clinical research, has been named one of the top 100 Best Places to Work in 2018 by the Atlanta Business Chronicle. Florence was named the #11 best place to work in the small business category. “This honor is a testament to our team,” [...]

Florence Named to Top 100 Places to Work in Atlanta2021-05-20T10:30:15-04:00
7 08, 2018

Ten Must-Have Capabilities When Evaluating eRegulatory Platforms

2021-05-20T10:17:46-04:00

Successfully transitioning your team to an eRegulatory solution, while avoiding costly compliance mistakes and realizing true time-saving benefits, requires careful evaluation of potential platforms. After helping thousands of research teams implement eRegulatory, our team has put together these ten essential capabilities to look for when evaluating solutions. You can download our full Guide to Selecting [...]

Ten Must-Have Capabilities When Evaluating eRegulatory Platforms2021-05-20T10:17:46-04:00
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
14 06, 2018

Webinar | Avoiding Digital Site Surprises

2024-12-02T13:37:33-05:00

Recorded Webinar: Avoiding Digital Site Surprises Odds are that your CRA team is already logging into electronic investigator site files at some of your sites. Now what? View this on-demand webinar to learn how leading sponsors and CROs are taking advantage of digital platforms at trial sites. We explore the how your [...]

Webinar | Avoiding Digital Site Surprises2024-12-02T13:37:33-05:00
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
4 06, 2018

Webinar | Surviving an FDA Inspection with eRegulatory

2024-12-02T13:36:52-05:00

On-Demand Webinar: Surviving an FDA Inspection with eRegulatory In this recorded webinar our panel of experts from Florence and LMK Clinical Research discuss how an FDA inspection works with eRegulatory, what the FDA is looking for, and how to prepare your site for a successful inspection. This recording is no longer available. [...]

Webinar | Surviving an FDA Inspection with eRegulatory2024-12-02T13:36:52-05:00
15 05, 2018

10 Superpowers of Clinical Trial Leaders

2021-07-27T20:20:36-04:00

While helping over 10,000 research teams migrate Florence eBinders for eRegulatory, we've encountered people who have become "superheroes" in managing the workflow of regulatory and source documents at their site. In working closely with them to take what they are doing now and move it to a streamlined digital workflow, we've identified ten types of these "superheroes" [...]

10 Superpowers of Clinical Trial Leaders2021-07-27T20:20:36-04:00
1 05, 2018

Webinar | Solving Clinical Trial Inefficiencies with eRegulatory

2024-12-02T13:41:52-05:00

Webinar: Solving Clinical Trial Inefficiencies with eRegulatory In this on-demand webinar our team examines how leading clinical trial sites are solving clinical trial operation inefficiencies with eRegulatory. Introducing eRegulatory into clinical trial trials is proving to deliver real operational improvements with a measurable impact on efficiency for thousands of trial sites. [...]

Webinar | Solving Clinical Trial Inefficiencies with eRegulatory2024-12-02T13:41:52-05:00
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
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
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
10 02, 2015

A Doctor’s Signature

2021-05-19T12:39:25-04:00

Ask any pharmacist about the quality of a doctor’s signature and you will hear horror stories about the scribble that is every doctor’s signature. Doctors' signatures are always so hard to read. The signature represents the doctor giving their approval to a plan of care. This signature of approval represents the years of studying [...]

A Doctor’s Signature2021-05-19T12:39:25-04:00
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