Yearly Archives: 2019

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22 08, 2019

The Evolution of Clinical Trial Monitoring through the eISF

2020-01-06T12:12:42-05:00

Clinical Trial Monitoring is an essential element of the clinical trial process and a vital connection between the sponsor/CRO and the Research Site. Monitoring is the sponsor/CRO’s obligation to ensure that the Research Site conducts the trial per the protocol, SOPs, GCP, and any other regulatory requirements. Ultimately, when conducting an IND trial, regulations [...]

The Evolution of Clinical Trial Monitoring through the eISF2020-01-06T12:12:42-05:00
29 07, 2019

Overcoming Four Common Challenges in Multicenter Research

2019-08-01T13:38:11-04:00

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 challenges of managing multicenter trials is unique for [...]

Overcoming Four Common Challenges in Multicenter Research2019-08-01T13:38:11-04:00
9 07, 2019

Integrating the eTMF and eISF: Why and Why Now?

2020-01-23T12:24:13-05:00

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 are conducted. Over the last five years, the [...]

Integrating the eTMF and eISF: Why and Why Now?2020-01-23T12:24:13-05:00
26 06, 2019

Technology in Multicenter Clinical Trials

2019-08-02T11:34:14-04:00

Are you part of a multicenter clinical trial? If not, you may be soon. Multicenter 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 timeline and reduce development costs. This growth is in direct [...]

Technology in Multicenter Clinical Trials2019-08-02T11:34:14-04:00
20 06, 2019

Pioneering New Methods of Remote Monitoring in Clinical Trials

2019-08-02T11:40:12-04:00

June 20, 2019, Atlanta, GA: Today Florence announced assignment of U.S. Patent No. 10,319,479 by the United States Patent and Trademark Office for: “Remote Monitoring and Dynamic Document Management Systems and Methods.” This patent covers how Florence’s applications process essential clinical trial documents—enabling a new approach to remote monitoring for Pharmaceutical companies, Medical Device [...]

Pioneering New Methods of Remote Monitoring in Clinical Trials2019-08-02T11:40:12-04:00
3 06, 2019

Driving Technology Standardization between Trial Sponsors and Sites

2020-01-14T09:11:08-05:00

Florence today announced its membership in the Avoca Quality Consortium® (AQC) to drive technology adoption and standardization in order to reduce drug costs and development time. Founded in 2011 by The Avoca Group, the AQC is a collaborative comprised of nearly 100 pharma, biotech, CRO, and clinical service provider companies with the shared objective [...]

Driving Technology Standardization between Trial Sponsors and Sites2020-01-14T09:11:08-05:00
22 04, 2019

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

2020-01-14T09:13:08-05:00

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 Research2020-01-14T09:13:08-05:00