Clinical trials will grow 5.8% from 2022-2030. To meet this growing demand, research sites, sponsors, and CROs will deploy purpose-built technology solutions.
Research sites are moving away from sponsor-first digital platforms (software designed for sponsors and CROs and forced on sites). Instead, they’re investing in site-first infrastructure across their research ecosystem.
Site-first solutions focus on research site teams, workflows, and processes. Emphasizing 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 and CROs also benefit from the site-first eClinical design approach. Sponsors’ systems can now link seamlessly 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 on the solutions used in clinical trial site document and data management.
4 Key eClinical Benefits for Clinical Trial Sites
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 regulatory compliance, and connectivity. Sites are placed at the center of the ecosystem while integrating directly back to sponsors and CROs for real-time 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.
Maximize Site & Staff Efficiency
Technology reduces and even eliminates many of the repetitive tasks individual team members are required to complete during the course of a clinical trial.
Streamlining and automating specific workflows allows clinical trial staff to maximize their time and focus on more strategic projects.
Increase Study Capacity
Traditionally, as the number of studies grows, the number of team members required to manage the growing number of documents and processes must grow at an equal rate.
Technology allows for rapid scaling of study capacity, with minimal increases in the demand on staff resources.
Streamline Sponsor Connectivity
Moving to a unified digital ecosystem for managing all study-related documents and data opens up advanced site and sponsor links. These links allow sites and sponsors to share documents and data with each other instantly and remotely throughout the course of a trial.
Sponsors and CROs are now directly integrating their technology with site eISF platforms to facilitate seamless document and data exchange. Pfizer used this technology to successfully complete their global COVID-19 trials.
Reduce Compliance Risks
Automating the recording and tracking of all tasks electronically on a single source of truth eliminates the human error element of misplaced documents, expired files, poorly compiled and written source information, and other common compliance risks.
The Electronic Investigator Site File (eISF) and other site solutions store 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.
In addition to an eISF, many sites also rely on eSource (electronic Source) and eConsent (electronic informed consent) to make their workflows more efficient.
Trends and Components of the eISF and Other Site Solutions
Historically, if a research site maintained an “eISF,” it was as part of a sponsor or CRO-deployed electronic portal. This approach, while beneficial for the sponsor or CRO, adds little value to the research site – and could even add to sites’ workloads, as sites must interact with dozens of different eISF platforms across sponsors and CROs.
The idea of eISF platforms designed specifically for sites became popular in 2019 and exploded during the COVID-19 pandemic. Site solutions like eISF, eConsent, and eSource continue to grow in popularity.
eISF platforms, sometimes called eRegulatory platforms, continue to grow in popularity. Florence’s research predicts that by the end of 2022, 89% of research sites will have an eISF. What is driving this rapid adoption?
- Regulation changes in both FDA 21 CFR Part 11 and ICH GCP E6 R3 that encourage electronic records in clinical trials and remote monitoring of research sites and staff
- Sponsor acceptance and expectation of digital site infrastructures
has grown slowly for two reasons:
- Larger research sites manage their primary source in an EMR/EHR and do not plan to replace this with a “direct-input” based system.
- Regulatory requirements have left a “gray area” around eSource that is just being explored.
has exploded in popularity among research sites.
- 88% of sites expect to use eConsent by the end of 2022–making eConsent as popular as eRegulatory!
eConsent solutions continue to evolve and add safeguards for compliance with regulatory requirements.
6 Key Benefits of a Site-first Platform
Eliminating paper and disconnected systems aren’t the only reason to invest in a site-first 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 and CROs.
Accelerate Study Startup
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.
- Deploy templated study binders across the entire research team.
- Use predefined placeholders for required documents, coupled with due dates and team member-assigned tasks to track performance.
- Automate workflows to route signature requests and completed documents to the appropriate people and places.
- Employ dashboards and reports to track all startup milestones across a single site or a multisite study in a single place.
Strengthen Regulatory Compliance
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 every document and every folder 24/7.
- Advanced permission controls ensure 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. Florence eISF is in use by multisite studies ranging from 6 sites to more than 200 sites.
- 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 give 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 for ensuring SDV is always compliant, secure, and possible.
- Integrate the eISF directly with the EHR/EMR to securely route subject visit 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.
Enable Remote Access
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, 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.
For more about remote access, check out our complete guide to the eISF + Remote Site Access.
Gain Real-Time Study Oversight
An eISF allows Research Site administrators to know 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.
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
Flexible Binder Structures
- Each site and study customizes their binder structures in a way that matches their workflows and processes.
eSignatures and Automated Workflows
- Assign and track electronic signatures without leaving your seat or navigating to multiple browsers.
- Documents requiring signatures are routed to the appropriate person in the proper order.
- Discover ten tips for launching compliant eSignatures in Clinical Trials.
In-Tool Document Editing
- Document tools such as document redaction, text annotation, highlighting, and stamping are available from within the binder—not a separate process.
- All edited document versions save and audit trail captures every change.
Secure Role Base Access
- Restricting and allowing access based on role ensures that only the appropriate parties view data.
- Allow for temporary or extended permissions to view, edit, and upload documents.
Alerts and Reports
- Single source of the truth across all studies and sites.
- Admin team can monitor compliance via reports.
- Users are notified of pending tasks, expiring documents, and missing files.
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.
To learn more about types of eSource, check out our comprehensive article.
Primary Features of eSource
Data Quality Verification
- Studies show that direct eSource capture reduces errors by 80% – from an average of 7% of data to less than 1% of erroneous data.
- Data checks during entry ensure that supplied data matches what is expected and alerts the user to variances.
Direct Integration with EMR/EHR
- Eliminate duplicate data entry by directly integrating the EMR/EHR with the eSource platform.
Direct Integration with the EDC
- Eliminate duplicate EDC data entry and errors caused by transcribing and transferring information.
Traceability, Tracking, and Transparency
- 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.
An eConsent system offers a digital platform that patients can use to read, sign, and submit their informed consent documents.
The FDA allows the use of eConsent, as long as that eConsent is compliant with clinical trial-specific regulations. Below is a quick list of features you should look for in your eConsent.
And if you’d like to learn more about what to look for in eConsent, check out our eConsent evaluation checklist.
Primary Features of eConsent
Patient Accessibility
- Multiple language options help staff reach a more diverse group of patients.
- Regulatory staff can upload documents to give patients additional information.
- Screen readers, the ability to change font size, and the option to change the screen color make forms more accessible.
- Patients have the flexibility to sign clinical trial forms on their own time, in an environment where they’re comfortable.
Compliance
- eConsent designed for clinical trials should offer 21 CFR Part 11-compliant eSignatures.
- Roles and permissions ensure only staff who should view informed consent forms can see them.
- Redaction features help regulatory staff protect patient information during remote monitoring.
Traceability, Tracking, and Transparency
- Audit trails let regulatory staff see when a document has been updated and by who.
- Tracking features let regulatory staff quickly identify which patients have viewed or signed consent forms and which have not.
- With version control, site teams no longer have to manually track which version of a document patients have signed. They can also quickly send out the newest version of a document if needed.
The CTMS provides a single, centralized system to manage operational and administrative activities in a clinical trial.
A CTMS is used by 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.
Although Florence doesn’t have a CTMS product, we perform integrations with many CTMS vendors who have an open API. Learn more about integrations and an open API here.
CTMS Trends
Clinical Trial Management Systems are among the first site-based eClinical solutions, and roughly 70% of sites use them as of 2022.
While Florence does not have a direct CTMS solution, we believe in the importance of eISF-CTMS integration. You can learn more about the types of integrations we support here.
Primary Capabilities of a CTMS per User Group
Clinical Program / Project Management
- Oversight of related clinical trials on a set of specific clinical project activities.
- Monitor progress at specific trial and program levels.
Trial and Site Planning
- Facilitates investigator and site identification as well as recruitment.
- Tracks key trial milestones such as target site/enrollment metrics.
Site and Subject Management
- Site monitoring and subject enrollment tracking relative to plan.
- CRF/eCRF completion status.
- Assists with scheduling of subject visits in adherence with protocol.
Investigator Management
- Manage relationships with investigators, based on visibility into the status of study data.
- Tracks approvals by institutional review boards (IRBs) and independent ethics committees (IECs).
Study Financial and Grant Management
- Track study costs.
- Reimburse investigators.
- Pay claims related to study activities.