Sponsors have a long tradition of offering software and/or services to their sites to make them more effective. Central eSource is the latest incarnation of this.
The history of sponsor provided tools
The first, and perhaps the most well known example, is Central IRB. Technically, each site has their own relationship with an IRB: the PI at the site must obtain the IRB’s approval to conduct the protocol and approval over the specific Informed Consent Form (“ICF”) to use.
Starting in the 1980s, sponsors began offering Central IRB services on an opt-in basis and today, the vast majority of sites – with the exception of some Academic Medical Centers – rely exclusively on the Central IRB. These sites receive a centrally approved ICF that they can then configure further, subject to final approval by the IRB.
A decade later, sponsors began offering Central Recruiting services, which involved the forwarding of patient prospects to sites as a way to complement their own recruiting sources.
Starting in 2015, we saw a significant uptake in sponsor-provided software and services. In short order, we saw sponsors begin offering to sites on their trials:
- Patient stipend/logistics: Cash cards that sites can load funds onto, which funds are provided directly by the sponsor, thus alleviating cash flow pressure for the sites.These services may also include patient travel services, removing a common barrier to patient participation, especially on rare disease trials where patients may be asked to travel a great distance to a participating site.
- EHR to EDC: A service whereby standard FHIR variables are pre-mapped to the study eCRF, along with software that permits the site to trigger the transfer of data collected in their EHR directly into the EDC, avoiding manual data entry.
- Virtual staffing: A service whereby virtual coordinators (central coordinators) are offered to sites to augment staff productivity. The PI may choose to delegate tasks to these staff members such as chart review, recruiting outreach, patient scheduling, phone visit completion, or EDC data entry.
- eRegulatory: A software system to automate the site’s Investigator Site Files (eISF). This offering may include the provision of a standardized digital folder structure along with the convenience of documents being sent in directly to the eRegulatory system.
Use of these tools has grown over the years – an indication that sponsors are receiving positive ROI on them. Site adoption may vary based on the type of service, therapeutic area, and specific site makeup, but adoption can range from a low of 15% to a high of 100%, with Central IRB a virtual de facto standard in the industry.
Central eSource – what’s new, what’s the same
Today, sponsors are discovering the value of Central eSource – a combination of an eSource software solution along with a pre-designed central eSource template for the study. This offering allows sites to accelerate site startup by avoiding having to build their own template from scratch, and leverages the power of CRIO’s eSource technology to collect data digitally – ensuring protocol compliance and expedited EDC entry through pre-mapped integrations.
This is the latest form of site technology, which sites are increasingly adopting of their own accord. It almost always displaces the use of much more inefficient paper worksheets, and it ensures not only the potential for faster and more accurate EDC entry, but also enhanced protocol compliance, faster startup, and better remote monitoring.
In many ways, this offering fits in with the tradition of sponsor-provided site tools:
- It’s provided on an opt-in basis.
- It lets sites utilize a technology that is natively site-facing, as opposed to a more traditional eClinical technology, which is fundamentally designed for sponsor use.
- Its core premise is to enable site productivity, standardize quality, and provide centralized transparency into critical site workflows.
Central eSource is even more like Central IRB than anything else
Central eSource most resembles the ICF component of Central IRB. Just as with the ICF, sites are responsible for the development and administration of their own source. Like the ICF, this process is essentially a translation of the protocol into a different format – in the case of an ICF, an eighth-grade level summary for the lay reader; in the case of source, a series of workflow steps to guide the site staff in collecting data.
Finally, both document types (the ICF and the source) need to address the right balance between being standardized and being configurable. Like a centrally designed ICF template, CRIO’s Central eSource starts with a uniform template that captures the critical components of the protocol. And just like sites can configure their ICFs to meet their site requirements, sites can use CRIO to further tailor the centrally designed eSource template. Just as the IRB will work with the sites to review and approve these changes, CRIO can offer a similar service, directly implementing site-requested changes as needed.
If you’re a sponsor, you probably take the concept of a central IRB for granted. Can you imagine going backwards to a time when individual sites are responsible for developing their own ICF forms from scratch? The result would be significant startup delays, massive variation in ICF quality, and – inevitably – differing interpretations of the protocol being executed, resulting in protocol deviations.
Yet that is exactly the state of site source design currently. Source design can take upwards of 5 consecutive business days to design and develop; because sites need to fit this task into a busy schedule, it frequently ends up delaying startup by weeks. And, like an ICF, a poorly designed template can literally induce protocol deviations. Just as centrally furnished ICFs are compliant, so are centrally furnished source templates.
Summary: Central eSource is the future of clinical research
Central eSource may be the most consequential sponsor-provided offering yet. Site-based eSource is not only the means by which sites collect their data, it also serves as a workflow tool to organize the site’s processes. With integrations, it can communicate with virtually any other system a sponsor uses – not just the EDC, but also central labs, randomization, eCOA and other vendors. As such, Central eSource could easily evolve into a broader operating system for research – a single dashboard to organize site workflows and collapse multiple logins into one intuitive site-facing platform.