eClinical Solutions for Clinical Trials - Florence eClinical

In response to rising clinical trial complexity, up more than 352% in the past decade, Research Sites are deploying purpose-built technology solutions.

Research Sites are moving away from using sponsor-first digital platforms (software designed for the sponsor/CRO and forced on the Site), to investing in site-first infrastructure across their research ecosystem.

Site-first solutions focus on Research Site teams, workflows, and processes. Focusing on sites when building eClinical solutions streamlines workflows, lowers costs, reduces compliance errors, and enables scale – ultimately accelerating the timeline of new medical advancements reaching patients.

Sponsors/CROs also benefit from the site-first eClinical design approach. Sponsor’s systems can now integrate with platforms at the site – resulting in sites working with a platform they are familiar with and enjoy using.

While numerous categories of eClinical solutions exist, this guide focuses exclusively on the solutions used in Clinical Trial Site Document and Data Management.

Purpose-built eClinical solutions for Research Sites place the investigator at the center of the clinical trial ecosystem.

4 Key eClinical Benefits for Clinical Trial Site

The benefits of introducing eClinical solutions at the research site go beyond merely moving out of paper. Integrated and interconnected platforms introduce a new level of efficiency, improved compliance, and connectivity. Sites are placed at the center of the ecosystem while integrating directly back to sponsors/CRO for realtime document and data exchange and monitoring.

Integrated and interconnected eClinical platforms at the Research Site result in greater efficiency, improved compliance, and real-time connectivity.

Electronic Investigator Site FIle (eISF)

The Electronic Investigator Site File (eISF) stores all documentation generated before, during, and after the study at the research site. All documentation must be complete, legible, and easily accessible at all times for monitoring and audits.

The eISF Platform combines eRegulatory, eSource, and eConsent into a single, unified, ecosystem.

Trends and Components of the eISF

Historically, if a Research Site maintained an “eISF” it was as part of a sponsor/CRO deployed electronic portal. This approach, while beneficial for the sponsor/CRO, adds little value to the Research Site – even adding additional workload as sites must interact with dozens of different eISF platforms across sponsors/CROs.

The complete eISF platform, featuring all of the components of the eISF (eRegulatory, eSource, and eConsent), began to become a possibility in 2019.

6 Key Benefits of eISF

Eliminating paper and disconnected systems aren’t the only reason to invest in an Electronic Investigator Site File.

When deployed correctly and integrated with existing systems, the eISF has the potential to transform the way Research Sites operate, and their relationship with sponsors/CROs.

eRegulatory | Electronic Regulatory Files for Clinical Research

An Electronic Regulatory Document Management System (eRegulatory) is an essential component of a fully functioning digital ecosystem at the clinical trial site. eRegulatory manages all of the regulatory-related documents created and maintained before, during, and after the study.

Primary Features of eRegulatory

eSource is the platform that captures the initial source documentation of subject data in the clinical trial. Instead of recording source data manually and then later transferring data to an online system, eSource captures data electronically from the start.

Methods of eSource Capture

EHR/EMR (Electronic Medical Records/Electronic Health Records): Integrate directly with the EMR/EHR to seamlessly capture the source documentation from the electronic health record.

Direct Data Capture: Direct data entry by site staff into a mobile application or EDC system.

Devices and Applications: Collection of data from non-site staff using mobile devices, wearables, and sensors.

Non-CRFs: The collection and transfer of data from sponsor sources (ie: laboratories) or external vendors.

Primary Features of eSource

eConsent | Florence Electronic Consent in Clinical Trials

An Electronic Informed Consent software system offers a digital platform for which to obtain informed consent for a clinical trial.

The FDA and Office for Human Research Protections (OHRP) stated in guidance for the use of eConsent that, “The research community is showing increasing interest in using electronic media to supplement or replace paper-based informed consent processes.”

Primary Features of eConsent

The CTMS provides a single, centralized system to manage operational and administrative activities in a clinical trial.

The CTMS is used by both sponsors/CROs and Research Sites to manage critical operational tasks across project management, facility/staff capacity planning, financials, subject tracking and scheduling, and protocol adherence.

CTMS Trends

Clinical Trial Management Systems are the most mature of the site-based eClinical solutions, with 60% of respondents saying they have a purpose-built solution in place, and the remaining 40% saying they use a general tool (like spreadsheets) to project manage their trials. 4

While Florence does not have a direct CTMS solution, our research from integrations with existing CTMS platforms indicates this trend will continue to grow over the next five years. 5

Primary Capabilities of a CTMS

Electronic Data Capture EDC

The sponsor/CRO deploys an Electronic Data Capture (EDC) system for the collection of clinical trial data at the research site in an electronic format. Data is typically recorded first at the site on paper documents before being transcribed into the system and saved in an Electronic Case Report Form (eCRF).

EDC Trends

In response to the increasing demand from sponsors to speed up the drug development process, and that of regulatory authorities for systems in place to ensure generation of high-quality data for accurate evaluation, there has been a gradual shift from the paper-based methods of data management to EDC systems.

First Analysis projects 85-95% of new clinical studies use EDC platforms.

As the eSource platform continues to evolve and become a staple at the research site, sponsors/CROs will begin integrating their Clinical Data Management Systems (CDMS) directly with the site eSource platforms, eliminating the need for duplicate manual transcribing of data into an EDC.

Tufts found that 85% of respondents to their survey indicated they plan to use eSource for some, or all, of their studies by 2020, with 87% indicating eSource will be a significant benefit for their research site.

Primary Capabilities of an EDC

As Research Sites deploy eISF platforms fully integrated with their existing systems (EMR, CTMS, IRB), sponsors/CROs can harness this infrastructure to connect and exchange documents and data with Research Sites directly.

Site + Sponsor/CRO Connectivity Trends

Demand for site connectivity has been increasing, with 52% of sponsors/CROs saying digital site connections are their top priority for the next three years. In response, software vendors serving the sponsor/CRO market have deployed “sponsor-first” software platforms, such as “site-portals,” to Research Sites. These platforms place the sponsor/CRO at the center of the ecosystem and generally add little value to the research site.

The fact that sponsors/CROs need more direct site connectivity isn’t changing – it is the only way to accelerate research while lowering development costs. However, the trend in connectivity is shifting the focus from sponsor-first solutions to integrating with site-first solutions.

Focus is shifting to integrating sponsor/CRO tools, like the eTMF, to purpose-built research site based infrastructure such as the eISF. This “site-first” model provides the sites the tools they need to get work done, while also enabling real-time connectivity back to the sponsor.

Florence is pioneering this model of connectivity by giving sponsors/CROs a single point of connection to the research sites through Florence eHub. Florence eHub directly integrates the sponsor/CRO eTMF platform with the research sites eISF.

Primary Capabilities of eHub

Florence Solutions Overview

Florence eBinders Global View

Florence eBinders – eISF

Florence eBinders™ is the eISF of choice for leading Research Sites. In use by over 5,000 Research Teams around the world, Florence eBinders™ features site-first eRegulatory, eSource, and eConsent capabilities.

Florence eTMF

Florence eTMF is the only eTMF on the market with the capability of directly integrating with over 5,000 Research Site eISFs. This feature rich platform is designed for the sponsor/CRO that needs maximum flexibility and ease-of-use.

Florence eHub

Florence eHub is the only connectivity platform that connects the sponsor/CRO eTMF directly to the Research Site eISF. Sponsors/CROs gain advanced site operational analytics, remote monitoring capabilities, and document/data exchange features.