StudyOrganizer – Your Complimentary Study Management Assistant

9 06, 2023

The Value of Connecting Your Sites to Your eTMF Workflows

2023-06-09T18:57:32-04:00

The Value of Connecting Your Sites into your eTMF Workflow In the ever-evolving landscape of clinical research, the effective management of essential trial documentation is critical to ensure compliance, efficiency, and data integrity. 70% of the TMF is generated by the site. Two key components of this process are the Electronic Trial Master [...]

The Value of Connecting Your Sites to Your eTMF Workflows2023-06-09T18:57:32-04:00
28 04, 2023

What You Need to Know About Using an eTMF and eISF in China

2023-11-29T19:52:02-05:00

What You Need to Know About Using an Electronic Trial Master File (eTMF) and Electronic Investigator Site File (eISF) in China for Clinical Trials In recent years, there has been an increase in clinical trial activity in China. At Florence, our mission is to advance cures for diseases and therefore we have been [...]

What You Need to Know About Using an eTMF and eISF in China2023-11-29T19:52:02-05:00
9 04, 2021

How the Trial Master File is Evolving (2021)

2023-04-16T23:02:54-04:00

How the Trial Master File is Evolving (2021) The Trial Master File (TMF) is one of the most critical elements of a clinical trial, in fact, it is one of the first items any regulatory agency requests. Yet, many organizations don’t place the same importance on the TMF as they do on patient [...]

How the Trial Master File is Evolving (2021)2023-04-16T23:02:54-04:00
24 03, 2021

Avoiding Failure When Migrating to a New eTMF

2021-03-25T09:08:28-04:00

Watch: Avoiding Failure When Migrating to a New eTMF In theory, the Trial Master File (TMF) is a collection of documentation that tells a cohesive story. But all too often sponsors are left piecing this story together retroactively due to disjointed site and sponsor systems, outsourced TMF management, and traditional [...]

Avoiding Failure When Migrating to a New eTMF2021-03-25T09:08:28-04:00
9 03, 2021

Seven Reasons Growing Biotechs Bring their eTMF In-House

2023-04-16T23:05:49-04:00

Seven Reasons Growing Biotechs Bring their eTMF In-House The electronic master file (eTMF) is essential to submit a clinical trial to regulatory agencies. As part of clinical operations' active management, the eTMF gives sponsors real-time visibility into quality, timeliness, and completeness across their studies. Biotech companies starting their first few clinical trials typically [...]

Seven Reasons Growing Biotechs Bring their eTMF In-House2023-04-16T23:05:49-04:00
31 07, 2020

Selecting an eTMF Vendor that Empowers Site Collaboration

2023-04-16T23:11:23-04:00

Selecting an eTMF Vendor that Empowers Site Collaboration Not all sponsors and CROs that select and implement an Electronic Trial Master File (eTMF) solve the bottlenecks and inefficiencies that the system was selected to target.  Why?  Often, during the vendor selection process, organizations undervalue the impact of vendor support teams, overlook critical implementation processes, [...]

Selecting an eTMF Vendor that Empowers Site Collaboration2023-04-16T23:11:23-04:00
31 07, 2020

The Overall Organizational Impact of a Modern eTMF

2023-04-16T23:11:52-04:00

The Overall Organizational Impact of a Modern eTMF Implementing an eTMF is critical for Sponsors and CROs that want to reduce burden, increase study capacity, and enable more trials. However, many organizations are not equipped with a modern solution to realize the full benefit and future proof operations. With over 10,000 research sites connected to [...]

The Overall Organizational Impact of a Modern eTMF2023-04-16T23:11:52-04:00
17 07, 2020

Complete Guide to the Electronic Trial Master File (eTMF)

2022-12-09T12:53:36-05:00

Free Download Complete Guide to the Modern Electronic Trial Master File (eTMF) Best practices from hundreds of successful eTMF deployments. This guide covers: The impact of a modern, active eTMF Return on investment & quality control Compliance with FDA regulations Vendor selection and more! Make sure your eTMF solution satisfies the needs [...]

Complete Guide to the Electronic Trial Master File (eTMF)2022-12-09T12:53:36-05:00
14 05, 2020

How to Prepare Research Sites for Rapid Technology Evolution

2023-04-16T23:15:31-04:00

How to Prepare Research Sites for Rapid Technology Evolution Before a research site can take advantage of new technology platforms, it must first ensure it has a solid foundation from which to build. Research sites that have not prepared for the coming wave of technology advancements will find themselves lagging behind their peers [...]

How to Prepare Research Sites for Rapid Technology Evolution2023-04-16T23:15:31-04:00
14 05, 2020

How Technology is Impacting the Clinical Research Landscape

2023-04-16T23:16:38-04:00

As technology continues to transform Clinical Research operations, both research sites and sponsors are investigating ways to leverage this technology to make the most impact on their organizations and research as a whole. As a technology vendor ourselves, we often hear that organizations are continually approached by new technology vendors entering the market. This [...]

How Technology is Impacting the Clinical Research Landscape2023-04-16T23:16:38-04:00
28 03, 2020

Download | 37 Clinical Software Cloud Computing Terms to Know

2021-06-16T09:13:26-04:00

Free Download 37 Clinical Software Cloud Computing Terms Glossary A collection of terms and definitions related to cloud computing and areas of interest for Clinical Research organizations that are currently evaluating eClinical platforms and technologies. Download Glossary What you will [...]

Download | 37 Clinical Software Cloud Computing Terms to Know2021-06-16T09:13:26-04:00
18 02, 2020

How the MAGI eISF Reference Model Will Impact Your Work

2023-04-16T23:19:01-04:00

eISF Reference Model Overview You’ve likely heard that the MAGI Global eISF / eReg Binder Reference Model Version 0.9 is open and available for review. By now, you may be wondering what’s next for me and my organization? Our representative on the MAGI eISF Reference Model Steering Committee, Jordan Tapley, walks us through [...]

How the MAGI eISF Reference Model Will Impact Your Work2023-04-16T23:19:01-04:00
20 12, 2019

Webinar: Solving TMF Quality and Completeness

2019-12-30T09:44:49-05:00

Webinar Recording: Solving eTMF Quality and Completeness How Sponsors and CROs are solving the weakest link in Trial Master File Completeness and Quality - site document access. Admit it, eTMF inspection readiness keeps you up at night. In this webinar, learn from your peers about how to fix it with a [...]

Webinar: Solving TMF Quality and Completeness2019-12-30T09:44:49-05:00
4 09, 2019

Download | Benefits of an Open API in eClinical Software

2021-06-16T09:22:45-04:00

Download: Benefits of an Open API in eClinical Software Avoid being locked into a single clinical trial software and encountering future bottlenecks by ensuring integration of best-in-class platforms. To maximize the benefits of eClinical platforms, it is essential the stakeholder (i.e., Clinical Trial Team, Research Site, CRO, or sponsor) understands the [...]

Download | Benefits of an Open API in eClinical Software2021-06-16T09:22:45-04:00
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
14 08, 2019

Webinar Recording | eTMF + eISF Integrations: Why and Why Now?

2019-08-14T11:03:06-04:00

Watch: eTMF + eISF Integration - Why and Why Now? Discover how it is now possible to directly integrate the eTMF and the Research Site eISF to accelerate research by connecting in a unified digital ecosystem. The use of electronic documentation in clinical trials, both at the site (eISF) and the [...]

Webinar Recording | eTMF + eISF Integrations: Why and Why Now?2019-08-14T11:03:06-04:00
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
12 05, 2019

Download | eTMF Capability and RFP Checklist

2022-06-22T18:59:41-04:00

Learn what Capabilities an eTMF Needs to Power Your Clinical Operations Effectively. In this free eTMF capabilities and evaluation checklist, you'll get insights into what features and functionality you should look for in an eTMF for your clinical trial operations. Compiled from working with hundreds of sponsors, CROs, and research sites. In [...]

Download | eTMF Capability and RFP Checklist2022-06-22T18:59:41-04:00
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
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
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
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

2019-08-02T15:56:28-04:00

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 Surprises2019-08-02T15:56:28-04:00
3 05, 2018

Webinar | Blockchain and Clinical Trials

2022-10-20T11:57:31-04:00

Webinar: Blockchain and Clinical Trials Watch this on-demand webinar as our Chief Technology Officer explores the impact of Blockchain on Clinical Trials, and if you should be planning for it at your organization. Blockchain’s potential impact on the healthcare space is immense. The buzz surrounding blockchain technology is warranted and should [...]

Webinar | Blockchain and Clinical Trials2022-10-20T11:57:31-04:00
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
28 02, 2016

The Other Side of EDC and eTMF: A Webinar with SCRS

2022-11-30T11:17:18-05:00

EDC and eTMF applications streamline data capture for sponsors, but what is the rest of the digital story for sites? How close is the industry really to linking electronic source and moving beyond three-ring regulatory binders? Hear what lies in store for sites in 2016 and how digitization can affect investigator oversight, document processes, [...]

The Other Side of EDC and eTMF: A Webinar with SCRS2022-11-30T11:17:18-05:00
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