Source: https://florencehc.com/pillar-page-eregulatory/
Timestamp: 2020-03-31 02:14:12
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Clinical Trial eRegulatory Overview and Guide | Florence
Clinical Trial eRegulatoryAngela Collevecchio2020-03-03T13:32:00-05:00
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.
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.
Download Guide to eRegulatory
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.
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.
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 6,200 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.
Download the ROI of eRegulatory Guide
A key driver of Research Sites making the move to an eISF is the acceleration of study startup time – with many sites seeing a reduction of more than 50% of their average startup time (one major NCI cancer center is now approaching an average of only 26 days from SIV to Ready for First Patient In).
Single-click deployment of templated study binders across all research teams.
Predefined placeholders for required documents coupled with due dates and team member assigned tasks to track performance.
Automated workflows to route signature requests and completed documents to the appropriate people and places.
Dashboards and reports to track all startup milestones across a single site, or a multisite study in a single place.
Sites are reducing and even eliminating compliance risks related to document and data management with purpose-built eISF platforms.
Automated audit trails track every view, change, update, and signature on each document and folder 24/7.
Advanced permission controls ensure that only the approved individuals/teams can view, access, download, and edit files and folders.
Expired document notifications alert admins and users of documents set to expire such as CVs and other study critical documents.
Streamline Multicenter Management
As multicenter studies continue to increase, the Coordinating Center must have as much oversight and access to their research sites as possible. Multisite studies from six sites to 200 sites are using Florence eISF.
Standardize and distribute frequently used form templates with fillable fields to all sites.
Granular role-based access controls allow the coordinating center to ensure each site only sees what they are supposed to see.
Built-in quality control workflows allow centralized overview and collaboration before approving key documents.
User-friendly site workspace available anywhere on multiple devices gives sites the tools they need to get work done.
Eliminate Shadow Files
Directly integrating source documents into the eISF platform eliminates the need for shadow files and duplicate processes that ensure SDV is always compliant, secure, and possible.
Integrate the eISF directly with the EHR/EMR to securely route subject, visit and date directly into the appropriate file/folder/study on the eISF platform.
Use eSource Tablet or Computer interfaces to directly input source document data into the eISF.
Moving to a unified digital ecosystem for managing all study-related documents and data opens up the possibility of remote access and monitoring.
Advanced permission controls ensure monitors only see what they are supposed to see, and when they are supposed to see it.
Automated audit trails track monitor activity to give the site a complete picture of their actions in the eISF.
Part-11 and HIPAA compliant cloud-based platforms mean Research Site IT staff do not need to configure Firewall and other security infrastructures to enable remote access.
Gain Real-Time Study Oversight
An eISF allows site administrators to always be aware of what is happening in a study, identify study bottlenecks, and track milestone performance.
See completed, pending and overdue documents and tasks to analyze trial progress in real-time.
Manage participating study personnel directly through the platform without having to navigate to email or alternative notification systems.
Understand where studies acquire risky delays and mitigate potential issues before they arise.
Prove the ROI for Your Organization
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.
eRegulatory documentation must also be complete, legible, and easily accessible at all times for monitoring and audits.
There are three primary areas that need to be considered when thinking about Title 21 CFR Part 11 regulations:
Features of an eRegulatory Solution
Vendors that aren’t compliant with these regulations pose a severe risk of compromising the integrity of any clinical study.
It is crucial your eRegulatory vendor can prove they are fully compliant with all FDA Part 11 regulations, requirements, and recommendations.
Florence has been independently validated against all regulations set by the FDA, Industry Sponsors, IRBs, and Research Sites.
Here are a few FDA-related learning resources to review when examining an eRegulatory solution for clinical trial document management.
Top 5 Clinical Trial Site FDA Inspection Failures
Surviving an FDA Inspection with eRegulatory
Evaluating and Selecting an eRegulatory Vendor
Navigating technological terminology and intricacies is a complex process that can be daunting for individuals unfamiliar with eClinical technology.
After rigorous analyzation of thousands of capability data points from research teams utilizing our platforms, we put together these essential capabilities to look for when evaluating eRegulatory solutions.
One of the primary benefits of an eRegulatory platform is advancing project management. Automating redundant tasks and project workflows reduce document cycle times by as much as 40% – saving time and accelerating trials.
To achieve these results, project management capabilities should:
Be flexible enough to adapt to your workflows with custom binder structures, file types, roles, permissions, and naming conventions.
Have programmable project workstreams incorporating expected due dates, and required deliverables (tasks or documents).
Automate project templates and progress reports.
Customize dashboards that track metrics across studies, sites, and teams.
Eliminating paper frees up office space while drastically improving document oversight and cycle times.
When evaluating the functionality of document management, ensure the eRegulatory system:
Allows customizable binder structures while also configuring to reference models like DIA TMF, and NCI-NIH.
Centralizes repeated documents across studies (like CVs), so they only need to be updated in one location.
Provides built-in task management allowing monitors, study managers, research coordinators, and compliance teams to communicate within a tracked and audit-able environment.
Has automatic archiving at study close and long-term storage of all documents.
A fully FDA 21 CFR Part-11 compliant eSignature process is a principal driver for many research teams exploring eRegulatory.
When evaluating the eSignature capabilities, check for:
Fully compliant eSignatures with 21 CFR Part-11 requirements (your vendor should be able to prove this).
The ability to add signatures to addendum page logs and DOAs.
Line signatures that eliminate the need for wet signatures.
Part-11 compliant certified copies.
The ability for signers to decline to sign with a trackable reason.
Check out our Ten Tips for Implementing eSignatures in a Compliant Way here >
Strict access control and permissions to binders, folders, and documents is an essential requirement of all purpose-built eRegulatory solutions.
Specific features to look for in access and permission capabilities include:
Single sign-on authentication that enables one login across platforms.
The ability for administrators to edit access and permissions on multiple levels, including study, document specific and user-specific.
The ability for administrators to add new roles, new users, and customize permissions without contacting the vendor.
Migrating all workflows and users to new processes requires a true partnership between the organization and vendor. No one wants to sign a contract and still be waiting for implementation a year later!
When evaluating a vendor’s ability to implement a system and support a team, ask:
How long on average have previous implementations taken?
What does implementation support provide? Training, SOP development, support, integrations, or professional services?
Are Vendor SOPs included in implementation and support?
Is there a static training library and ticketing system?
How do disaster recovery and business continuity procedures work?
Download our Five Steps to User Adoption of eRegulatory Systems here
Traceability, Tracking, and Transparency
Specific features to look for in tracking and traceability include:
All source data is attached to a complete Audit Trail tracking who, when, where, and how the data is entered.
Source data is tied to milestone tracking to enable tracking across the study.
Questions to Ask eRegulatory Vendors
What are the basic features the platform has to have?
What resources are available to help me maximize technology and get my team on-board?
It is crucial to use tactical evaluation strategies to ensure confidence when selecting an eRegulatory system.
A few resources we created for this purpose are:
Ten Must Have Capabilities When Evaluating eRegulatory Platforms
10 Questions to Ask Your eClinical Software Vendor About API
To make an impactful solution, eRegulatory vendors must listen to customers and industry experts. Our site-first solution addresses challenges seen by the industry, organization, role, and end-user.
Customer and market-driven features and functionality continue to be a primary focus when creating the product roadmap at Florence.
We encourage you to compare value across vendors to make an informed decision on an eClinical software that addresses your pain points and accelerates your trials.
After selecting an eRegulatory software solution that is best suited for your organization, the process of implementation and user adoption begins.
A detailed change management plan is essential to capture the estimated benefits you calculated during your Return on Investment evaluation.
This team will act as the core group for all implementation related activities.
Assign an implementation or change management leader to kick-off the “tiger team.” The assigned implementation leader will manage the communication to stakeholders inside and outside your building.
Additional best practices can be found in the Complete Guide to eRegulatory and eSource (we suggest page 12).
Build eRegulatory Specific Standard Operating Procedures (SOPs)
Specific eRegulatory SOPs are a crucial element of a robust change management plan. These SOPs will be training documentation for new personnel and critical procedures for a successful audit.
It is an eRegulatory vendor’s responsibility to provide your team with guidance and best practices for building these SOPs.
Utilize a Formal Training Program
An evergreen training program is vital for optimizing the value you receive during and after implementing any software platform. Both current and new users can return to these resources at any time to be fully educated on all applicable use cases for his or her role.
Your team will have varied technological skill sets and knowledge. Your eRegulatory software vendor should provide ample support, if needed, for all team members. The vendor should equip your organization with both a knowledge base and training resources that allow even the most technically timid user to feel comfortable going digital.
Most research sites have tried and true processes and procedures that are imperative to study management. These fundamental components may also involve the use of other eClinical software.
Successful eRegulatory implementations don’t necessarily replace these processes. eRegulatory should enhance, improve and scale what you are already doing.
Identifying key processes and aligning your eRegulatory solutions to work with and not against them, will help you replace extraneous steps with a streamlined and efficient digital process.
Using an open API vendor will allow you to create one centralized hub for all eClinical solutions to communicate with one another.
Based on performing hundreds of implementations for sites that adopted eBinders™, are team has identified 4 integrations your eRegulatory solution must have:
Developing an eRegulatory strategy can expose challenge hotspots and illuminate the total eRegulatory project scope. This Roadmap to eRegulatory guide features tips and insights compiled from hundreds of successful site, sponsor, and CRO implementations.
Download Five Essential eRegulatory Integrations
A carefully considered and planned user adoption strategy (and a little celebration) is needed to enable newfound time savings and operational efficiencies.
One area that is sensitive to change is your team members. Building a plan that encompasses a detailed implementation and offering ongoing training and support will reduce the organizational impact on your team.
The Florence team has helped our customers with this important final step while also retaining and integrating with other important eClinical software platforms your team is comfortable using.
This process is simplified in this ebook that breaks down Five Steps to User Adoption in eRegulatory. This document is focused on your internal team and is a great resource for making sure your team is both excited and motivated to learn a new system.
What’s more? Sponsor acceptance of your new eRegulatory solution is an issue of the past.
In fact, sponsors expect sites to be technology-enabled and review this criteria during the site selection process. An eRegulatory tool directly impacts a site’s study start up time, which in turn impacts money spent by sponsors.
eRegulatory is the most mature part of your overall eISF and eClinical solution. Don’t get left behind and miss out on the opportunity to scale your operations and gain (or maintain) a site-of-choice status.
Discuss what eRegulatory will look like at your clinical trial site with the Florence team.
Florence Solutions Overview
Florence eBinders™ – eISF
Florence eBinders is the Electronic Investigator Site File of choice for leading Research Sites. In use by over 6,200 Research Teams around the world, Florence eBinders features site-first eRegulatory, eSource, and eConsent capabilities.
Florence eTMF is the only eTMF on the market with the capability of directly integrating with over 6,200 Research Site eISFs. This feature-rich platform is designed for the sponsor/CRO that needs maximum flexibility and ease-of-use.
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.
Impact of eRegulatory
eRegulatory Compliance
eRegulatory Vendor Selection
Implementing eRegulatory
eRegulatory Integrations
eRegulatory Adoption