Company insight Reduce monitoring costs
The largest line item that researchers still pay for is bound up in the activity of Source Document Verification (SDV). ProofPilot explains the future role of SDVs and charts a path for clients to drastically lower costs and increase productivity.
D
id you know that the largest line item that researchers still pay for is bound up in the activity of
Source Document Verification (SDV)? Despite the hype around Decentralised Clinical Trials (DCTs), the vast majority of research will not be siteless. Where there are sites, there will be monitoring visits, for which SDV is a main driver. SDV is conducted to ensure that the data collected is reliable, allowing reconstruction and evaluation of the trial, fulfilling the ICH E6's requirements of accuracy and completeness. During Covid-19 lockdowns, many trials were halted and clinical research associates (CRAs) were furloughed because a remote SDV option was not available. While new-fangled, tech-enabled service companies continue to create more expensive DCT solutions for an, as of yet, unproven ROI at scale, researchers are left to pay exorbitant fees for an in-person activity that should have been disrupted years ago.
Three methods for rSDV Methodology
Direct EMR Access Description
CRA has remote access to EMR data of consented patients as if they were onsite.
Paper/Image upload
Paper or electronic documents are uploaded into a platform for comparison.
Limitations
Sites are generally still getting used to a behind the FHIR wall setup.
Many do not have the IT support to create rSDV roles for CRAs.
Time consuming for the site.
Challenging for the CRA to review/annotate.
Platforms need proper securities to allow for unredacted document/ image upload and review.
Patient mediated EMR access via API
The CRA is able to review the patient’s EMR via a 3rd party platform’s API.
monitoring capabilities have helped to ease the burden and time spent on site, it has not eliminated the need for SDV, which will remain a pillar of rigorous clinical research at least until direct EMR to EDC transfers are flawless and 100% comprehensive.
“While limitations exist for all [rSDV] methods, implementing the right combination will drastically lower costs, increase productivity [...] and enable sustainability.”
Conservative estimates for travel costs associated with site monitoring visits include $2,000 for pass-through expenses and $1,600 of travel labour per visit – all before anything of value has occurred. Based on a 50-site study at eight visits a year per site, travel alone can generate a price tag of about $1.5m a year. This model is also a drag on productivity, forcing CRAs to spend 50%–67% of their time travelling. Not to mention site scheduling and resource issues, which can derail planned visits and delay critical review efforts. Although risk-based and remote
Clinical Trials Insight /
www.worldpharmaceuticals.net
Efficiency includes cost reduction However, there is no reason to bear this enormous cost of SDV while we wait for the perfect mousetrap. Remote SDV (rSDV) is here and can create both instant savings and improved productivity, without the painful transformation of a two to five year operations overhaul. There are three main approaches to rSDV, and ProofPilot’s platform can enable all of them. While limitations exist for all methods, implementing the right combination will drastically lower costs, increase productivity
Best practices are still being learned.
at both the individual and organisational level, and enable both professional and environmental sustainability. As the industry continues to pursue more ambitious solutions, we need not continue to suffer the costly, antiquated traditions of yesterday. In fact, high value solutions like rSDV can be implemented immediately without putting a trial at risk or requiring the heavy lift of change management across an organisation. Innovation often comes in the simplest forms.
Company insight
ProofPilot is a US internet company founded in 2014, with headquarters in New York City, New York. The software as a service (SaaS) product is created for anyone to design, launch, participate, and engage in research studies. ProofPilot Rx is the flagship solution for Life Science companies, supporting digital design, automated orchestration, data collection, patient engagement and site monitoring. Radically scale capabilities to design and conduct remote, hybrid and in-person trials with speed and affordability. ●
www.proofpilot.com 41
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53
