How Remote Monitoring Increases Regulatory Compliance for Your Studies
This article was originally published on PharmaLive.com by Andrea Bastek, Director of Innovation at Florence.
The rapid shift to remote site access and monitoring during COVID is beneficial to keeping study timelines on track and indicative of the future of clinical operations. However, this rapid innovation rate will create study failure risk if not viewed through how it impacts regulatory compliance.
Outside of patient safety, one of the biggest fears a sponsor faces is receiving an inspection report with:
Failure to ensure proper monitoring of the investigation and failure to ensure that the investigation is conducted in accordance with the general investigational plan and protocols contained in the IND [21 CFR 312.50 and 312.56(a)]. 1
According to the FDA Bioresearch Monitoring (BIMO) Fiscal Year 2019 Metrics 2:
- Common Sponsor/Monitor/CRO Observations from 113 inspections include “Failure to bring non-compliant investigators into compliance,”
- Common Sponsor-Investigator Inspectional Observations include “Failure to ensure proper monitoring of the clinical investigation”
With life sciences technology vendors quickly introducing “remote monitoring” solutions, the risk of non-compliant software, processes, and Standard Operating Procedures (SOPs) may have the unintended consequence of putting your study at risk.
How many sponsors are re-writing monitoring plans with COVID-19 as justification for their updates? How many Premarket Approval Application (PMA) or New Drug Application (NDA) submissions this year will fail to meet their pre-prescribed monitoring goals? How will these failures and findings affect the overall approval timeline?
While it is unclear the long-term impact accelerated shifts to remote monitoring will have on the industry, one thing is clear: we need to be laser-focused on how to ensure compliance while living in a season of accelerated innovation.
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So, how do you avoid compliance risks when introducing new technology like a remote site access platform?
Adopting a technology platform is difficult for any business, especially those with tight compliance regulations like those in the clinical trial industry.
As a software vendor in the clinical trial space, we often find ourselves completing detailed Request for Proposals (RFPs) with lengthy Security Questionnaires’ while responding to numerous compliance questions that arise during the vendor selection process.
Sponsors and CROs are often hesitant to move to remote processes because of compliance fears. But, through 10,000+ study site implementations on an eISF + Remote Site Access platform at Florence, we’ve found the opposite is true: purpose-built, site-centric remote access solutions dramatically increase compliance.
Why does compliance increase? Here are the top three ways I’ve found sponsors and CROs increase compliance with a purpose-built, site-centric, remote access platform:
Sponsors and CROs get faster alerts to compliance risks at sites.
Remote monitoring and access technology reduces the time wasted on travel logistics and allows for real-time access to more data. Real-time access creates an opportunity for faster identification of protocol compliance trends, source data accuracy, and subject recruitment, as a few examples.
Sponsors and CROs can design more effective monitoring plans if all study sites are on the same platform with full remote monitoring capabilities. Central monitoring analytics allow risk-based monitoring (RBM) plans to pivot in real-time rather than remaining static and relying on random site and patient selection.
Sponsors and CROs can deploy flexible monitoring strategies across diverse study types and geographically dispersed sites.
Remote site access and monitoring give the sponsor the ability to design a protocol plan that takes advantage of different opportunities and advancements.
Some of the examples we’ve seen:
- Risk based monitoring (RBM): In the era of RBM, sponsors and CROs may still need 100% source data verification (SDV) for critical variables. A robust remote monitoring platform ensures easy access to all sites, saving time and money compared to traditional monitoring methods.
- Randomized Clinical Trials: The logistical and financial challenges of monitoring requirements often hinder randomized clinical trials.3 Remote monitoring and access platforms give sponsors the flexibility to design a monitoring plan based on what is best for the study.
- Accelerated Studies: Remote monitoring capabilities provide the ultimate flexibility in terms of accelerating monitoring timelines for urgent database locks or snapshots, investigations of unexpected adverse device effect (UADE) reports, and routine monitoring events such as first periodic monitoring visit (PMV) deadlines, and close out visits (COV).
- 100% SDV Studies: While declining as a percentage of overall studies, 100% SDV studies do exist. In these cases, site-specific technology limitations are a huge problem. A study-wide platform for remote monitoring eliminates those barriers.
- Hybrid/Decentralized Studies: A centralized cloud-based solution enables compliant remote monitoring of dispersed participants and site types.
- Remote monitoring and access technology make internal, independent, and study-wide audits of sites easier and faster. This technology also provides more resources to help sites prepare for BIMO inspections.
Monitor compliance across protocols and study sites.
Many sites participate in multiple protocols from a single sponsor. However, with traditional monitoring, site performance data from one study rarely gets used to trigger action on another study.
With an entirely virtual platform, identification of site-level issues in one protocol, such as repeated late SAE reporting, lack of source data for a particular data point (ex. specific lab test), or inclusion/exclusion or informed consent deviations, could be designed to trigger a remote monitoring review of other protocols immediately. This immediate trigger allows for more streamlined monitoring with less time-burden on both the site and sponsor/CRO.
In Conclusion
The benefits of integrating your trial sites on an eISF + Remote Site Access platform extend beyond the immediate impact of completing monitoring visits virtually. A purpose-built platform accelerates your overall trial timelines and creates a conducive environment to remain compliant before, during and after your trial.
In this “new normal” we are all adapting to, the willingness to adopt remote monitoring platforms in clinical trials will help differentiate the most successful sponsors from the rest.
About the Author: Andrea Bastek is the Director of Innovation at Florence, the largest eISF + Remote Site Access platform in clinical research with more than 10,000 study sites across 44 countries connected. She has extensive experience in the clinical trials space for medical devices, including deep collaboration with sites to drive processes that ensure successful study participation. She is committed to finding workflow efficiencies that improve clinical trial execution. She holds a Ph.D. in Biomedical Engineering from the Georgia Institute of Technology.