The Ultimate Guide to eRegulatory in Clinical Trials

What is eRegulatory in Clinical Trials?

eRegulatory is an electronic version of the binder maintained at clinical trial sites manage regulatory documents created before, during, and after a clinical trial to comply with regulations associated with medical development. The eRegulatory platform is the crucial component of the Electronic Investigator Site File.

Virtual binder or electronic binder systems solve the challenges of digital compliance, physical document storage constraints at trial sites, and information sharing with sponsors and CROs.

What is eRegulatory?

A site-operated eRegulatory solution enables efficient sharing of essential regulatory documents between research sites and sponsors while remaining 21 CFR Part 11 compliance.

Utilizing an eRegulatory system significantly streamlines multicenter clinical trial management. As a result, coordinating centers gain communication and performance efficiencies across participating sites of all ongoing studies

Leading academic research centers, clinical trial site networks, and independent sites are now harnessing the scalable capabilities of an integrated Electronic Investigator Site File (eISF) solution.

Research centers must build an Electronic Regulatory strategy to identify key project goals and generate requirements for core functionalities.

Who uses eRegulatory?
How eRegulatory Impacts Clinical Trials

How eRegulatory Impacts Clinical Trial Management

The increasing complexity of clinical trials within the last decade has forced research sites to respond with new technology and regulatory processes. Clinical trial sites now deploy eRegulatory systems to streamline the management of the required regulatory documents.

Site-first eClinical solutions streamline workflows, reduce cost, lower compliance errors, and enable study scalability for all participating trial organizations.

The Impact of eRegulatory on Clinical Trials

In response to site and sponsor needs, software companies have built numerous platforms in the past decade. Clinical Research Professionals are now overwhelmed with the extensive amount of eClinical solutions on the market.

Decision-makers face the challenge of selecting software that streamlines operations while reducing negative organizational impact.

Terms to Consider

  • Electronic Regulatory (eRegulatory) – an eRegulatory system for Clinical Trials is a compliant, digital platform that is utilized to complete, store and track regulatory documents before, during, and after the lifecycle of a clinical trial

  • Electronic Binders (eBinders™) – a term coined by Florence Healthcare in reference to a robust digital solutions for electronic regulatory binders, also referred to as eRegulatory

  • Electronic Investigator Site File (eISF) – combines Electronic Regulatory (eRegulatory), Electronic Source (eSource), and Electronic Consent (eConsent) into a single, unified, ecosystem

  • Electronic Clinical Software (eClinical) – any electronic software purpose-built for Clinical Operation Management

Understanding the ROI of eRegulatory is critical to make an informed decision.

Over 10,000 research teams managing eRegulatory on Florence eBinders™ have realized a significant return from moving to a site-first eRegulatory solution. The benefits appear in core categories, including increased team member specialization, more nimble operations, remote monitoring capabilities, increased efficiency, and a reduced risk of audit findings.

We compiled comprehensive data from these teams to build an ROI white-paper that explores six economic drivers for eRegulatory. This document extensively reviews the investment of an eRegulatory platform. 

Selecting an eRegulatory System

Clinical Research Compliance with eRegulatory

It is extremely important to select a compliant eRegulatory system for your organization.

eRegulatory is at the core of a site’s documentation from startup to close out and must be compliant with all digital regulations, including GDPR and HIPAA.

Requirements of an eRegulatory System

eRegulatory documentation must also be complete, legible, and easily accessible at all times for monitoring and audits. 

When thinking about clinical trial regulations from the FDA, ICH GCP, the MHRA, and other regulatory agencies, there are three primary areas your organization should consider:

If vendors don’t offer compliant features like audit trails, don’t help you create SOPs, or don’t assist with system validation, they could compromise the integrity of your clinical studies.  

It is crucial your eRegulatory vendor can prove they are fully compliant with all FDA Part 11 regulations, requirements, and recommendations. They should also prove their compliance with international regulatory and privacy standards. 

Florence has been independently validated against all regulations set by the FDA, industry sponsors, IRBs, and research sites. We have compliantly served clinical trial sites across 45 countries and 6 continents.*

The information presented here is for informational purposes only and is not for implementation in operations. Please consult official clinical trial guidance documents for operational use.

*Data as of 24Mar22

Here are a few compliance resources to review when examining an eRegulatory solution for clinical trial document management.