Clinical Trial Optimization Kit 

These resources were carefully selected from our learning center to help Research Sites begin to explore new technology advancements and operational processes to increase efficiency within their clinical trials.

Please click “Download” to directly download a resource to your desktop and “View” to be redirected to the resource in a new window. 

eClinical Solutions Guide

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.

This guide investigates the following solutions: Electronic Investigator Site File, eRegulatory, eSource, eConsent, Clinical Trial Management Systems (CTMS), Electronic Data Capture andSite-Sponsor Access Tools.

Complete Guide to eRegulatory and eSource

Shifting to eRegulatory and eSource workflows is a requirement for clinical trial sites to continue to scale and grow their studies.However, many site leaders are not fully prepared for the transition.

With over 7,200 clinical trial sites and sponsors now active in Florence eBinders, we have compiled this Guide to eRegulatory and eSource to assist trial sites in understanding important information when considering these technologies.

eISF Reference Model - Electronic Investigator Site File Reference Model - Image

Electronic Investigator Site File (eISF) Reference Model

The eISF Reference Model, developed in collaboration with WCG MAGI, numerous research sites and all leading eISF vendors.

The standard eISF Reference Model introduces a consistent binder and folder structure for the eISF that includes all essential documents a site needs to collect both internally for their own binder as well as any specifically for the sponsor/CRO in a clinical trial.