Sites, sponsors, and CROs now perform the bulk of their clinical trial operations by logging into cloud-based systems.
The rapid shift to digital document and data management solutions opened the door to innovative virtual collaboration solutions like Florence eHub. Florence eHub provides sponsors and CROs direct digital connectivity and collaboration access with their sites via connecting to the largest Electronic Investigator Site Files (eISF) in research.
In this article, we outline the impact on the below study processes:
- Document Completion, Collection and Submission
- System Set-up, Go-Live, and Site Initiation
- Site Monitoring and Management
- Source Data Review/Verification (SDR/V)
- TMF Oversight and Management
- Project Archiving and TMF Close-out
You can also access the complete whitepaper, “Harnessing the eISF”, which outlines each process and additionally includes key recommendations and quality outcomes of digitally accessing the site eISF.
Clinical Trial Document Completion, Collection and Submission
Regulatory document collection and submissions from sites are a bottleneck for sponsors and CROs, often prolonging study start-up timelines and increasing the overall cost.
Contribution to this bottleneck include:
- Reliance on in-person visits, email, or one-time use portals resulting in essential document delay, misplaced files, and imperfect quality copies.
- Inconsistent binder distribution and document collection processes across sites.
- Investigators and site staff that are slow to complete and submit documents because of belabored internal workflows.
- Sponsors and CROs must rely on relationships and anecdotal information, not actual site performance data, to select sites.
Sponsors and CROs eliminate these challenges when connected directly to a site via Florence.
Specifically, Sponsors and CROs on Florence eHub:
- Access and collect documents in real-time by turning-on direct remote access to the site’s eISF.
- Unlock study-wide insights and oversight into document quality and completeness by consolidating all sites in a single, consistent platform.
- Collaborate with sites remotely on documents in their workstreams.
- Accelerate document completion and submission by empowering Investigators with electronic features, such as eSignatures, to reduce task time from days to minutes.
- Track historical performance of sites on similar studies to ensure the selection of the best sites for your next study.
Through Florence eHub, Sponsors and CROs can decrease study start-up timelines with participating Investigators by as much as 40%.
eClinical System Set-up, Go-Live, and Site Initiation
The introduction of new technology at a site by Sponsors and CROs often results in low adoption and minimal return on investment caused by:
- Disruption of site workflows caused by the inability to integrate with existing software platforms (CTMS, ePro, EMR, EDC, eTMF, and Portals).
- Investigators and site staff resistance to new technology platforms.
- Added burden on CTA/CRA and IT staff in having to conduct software training and support.
- Compliance, security, ownership, and privacy concerns.
- Poor user interface (UI) design resulting in frustrated users.
Sponsors and CROs mitigate these challenges by partnering with providers of purpose-built site solutions.
Specifically, Sponsors and CROs harnessing Florence eHub benefit from:
- An integrated site-based solution that connects eRegulatory, eSource, eConsent, CTMS, EMR/EHR, eTMF, and email communications with an open API posture to eliminate workflow disruptions.
- A proven user interface in use by 7,200 Investigators.
- Security and privacy guaranteed via HIPAA, GCP, US CCPA & GDPR compliance.
Florence is committed to the successful implementation and adoption of its eISF solution at every site. The Florence Implementation team partners with Sponsor and CRO teams to:
- Support the development of unified folder structures and mapping between the eISF and eTMF.
- Assist sites in revising SOPs to enable an eRegulatory solution.
- Provide requisite training to both site and Sponsor / CRO staff.
The Florence team offers best-in-class Customer support, with proven paper-based to eISF site transition strategies resulting in rapid site adoption and activation.
Site Monitoring and Management
A critical barrier to accelerating research and increasing the timeliness, quality, and completeness of TMF data is the on-site monitoring visit.
The monitoring of sites is a crucial aspect of the clinical study. It often requires on-site visits, as most sites have not yet employed remote access solutions. These on-site visits lead to significant challenges for the Sponsor/CRO, including:
- Crucial data that is not available until the next monitoring visit, severely limiting the ability to manage sites in real-time, uncover issues, and identify bottlenecks.
- On-site visits that are challenging to schedule and disruptive to the site’s day-to-day operations.
- The difficulty of maintaining visibility into essential study documents, source, and related tasks.
Sponsors and CROs mitigate these challenges by connecting directly to the research site’s eISF platform.
Specifically, Sponsors and CROs partnering with Florence eHub transition a majority of their on-site visits to remote monitoring visits resulting in:
- A constant, digital site presence for regulatory document review, collection, and study-related communication.
- Study-wide reporting for site performance monitoring.
- Streamlined workflows that can happen remotely within the tool.
This direct site connectivity is a crucial driver of successful Sponsor and CRO clinical studies and working relationships.
Source Data Review/Verification (SDR/V)
Source Data Review/Verification (SDR/V) is one of the most challenging tasks for Sponsors and CROs to perform remotely.
Each site has its systems, rules, regulations, and processes regarding how Source data is collected, stored, and exchanged.
Reliance on paper files or remotely inaccessible EMR/EHR systems requires on-site visits during which manually scanning, uploading, redacting, and accessing Source data adds to wasted time.
Within Florence eBinders, sites may electronically collect, store, route, and manage Source documents.
Site staff collects Source documents from any platform (EMR, EHR or paper Source documents), and transmits them to the appropriate location within the eISF while redacting sensitive PHI.
Sponsors and CROs then access this source data remotely, and securely, in a compliant platform.
The patented permission and access control system powering Florence eHub ensures that the site maintains control and ownership of their document per ICH GCP E6 R2 regulations.
This remote SDR/V capability gives Sponsors and CROs the ability to access Source data and verify CRF and EDC information anytime.
TMF Oversight and Management
Disjointed eISF to eTMF processes result in delays to study completion and submission.
eTMF quality and completeness is a crucial challenge for many sponsors and CROs. These result from:
- Delayed site document uploads due to email systems, mislabeling, and misfiling.
- Poor quality documents due to scanning, shipping, and printing.
- Limited visibility into incomplete site documents and eTMF management status.
Sponsors and CROs mitigate these challenges by investing in software platforms that directly integrate the site eISF to the sponsor/CRO eTMF.
Specifically, sponsors and CROs partnering with the Florence eHub platform to streamline eTMF completeness, quality, and timeliness through the Monitor Review Module.
Florence’s Monitor Review Module grants sponsors and CROs:
- Remote site access for document review
- Quality control workflows
- Direct eTMF mapping
This solution eliminates the reliance on email, site visits and shipping to exchange documents during the review and approval process.
Sponsors and CROs benefit by transitioning monitors from redundant tasks associated with document management to strategic, measurable contributions on eTMF completeness and quality.
Furthermore, this single-platform ecosystem eliminates disruptions associated with CRA turnover. All documents, tasks, and communications are retained within the system and readily accessible to newly assigned CRAs.
Taking Advantage of Site Access Tools
Sixty-three percent of research sites surveyed in the Florence 2020 State of the Industry Report plan to have an eISF platform by the end of 2020.
Sponsors and CROs are well-positioned to take advantage of this convergence of purpose-built technology, a critical mass of over Investigators, and a primary focus on remote connectivity to streamline their clinical operations.
Organizations that take advantage of direct digital site connectivity will be in an advantageous position:
- Accelerating study start-up processes by as much as 40%.
- Enabling remote monitoring and SDR/V while reducing on-site visits.
- Gaining real-time visibility into research site operations.
- Increasing eTMF quality and completeness.
- Potential accelerating regulatory submissions.
Additionally, these sponsors and CROs become more productive and efficient in limited travel and restricted site access.
Florence is a pioneer in this field and the only remote site access, monitoring, and SDR/V platform on the market with a critical mass of over 7,200 Investigators.
Sponsors and CROs must take advantage of this transformation early to ensure business continuity and long-term study success.
Download the quick guide to How Sponsors Accelerate Trials Through Site Access to review at anytime while you evaluate site connectivity solutions and investigate different technology options.