eClinical Solutions for Clinical Trials - Florence eClinical Header

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.

Clinical Trial Site Portal World Map

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 Files - Florence eClinical Solutions Header

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.