Over 600 Principal Investigators are using CRIO eSource – are yours?
Sites that utilize the CRIO eSource system are making a conscious decision to invest in quality. Due to real-time edit checks, our system cuts down on common mistakes such as missing signatures, wrong calculations, or incomplete source data. In fact, an experienced Quality Auditor found that our system has safeguards against 50% of the most common audit findings.
As a sponsor or CRO, you can access source data over the web immediately after the visit is completed. You can leave “comments”, or queries, for a procedure or a data point, and direct it to a specific site staff member for greater accountability. If the site utilizes our Lab Routing feature, you can view marked-up, e-signed files such as lab reports, medical records, or Informed Consents.
When you work with a site that utilizes the CRIO eSource system, you can expect:
Sites who utilize our system over paper source are, on average, more experienced, higher enrolling and – by definition – more tech-forward.
Click here to download the full presentation "What is the Advantage of eSource in Clinical Trials?"
No backdating, no fraud
Our 21 CFR part 11 compliant system captures and displays an unalterable audit trail on all original and modified data points. Sites that embrace our technology are committing themselves to a level of data transparency not replicable in a paper-based environment.
Think this is not an issue? Read here for one CRA’s harrowing account of fraud at a research site.
How do you show the system is part 11 compliant?
We have third party attestation that our policies and procedures conform to 21 CFR Part 11. We furnish a variety of documents to our sites to demonstrate compliance. We also provide our clients with tools and training to ensure they implement our system in a compliant manner.
How do CRAs get access?
Your sites will give your CRAs study-specific, read-only access. Your CRAs will be able to log in via the web, view source data (including uploaded files), and leave behind queries.
Is there CRA training?
Your sites can provide access to a training video we have created for CRAs.
Can you integrate with our EDC system?
If you use Medidata RAVE, then yes! We have built a data integration program with Medidata whereby our system transmits data on a nightly basis directly to the eCRF. Please contact us to learn more.
Do you offer this to sponsors?
Yes! If you offer our system to your sites, you can perform remote monitoring, get immediate access to data, and experience improved data rigor. Please contact us to learn more.
Wait – aren’t the sites using their Electronic Health Record system? Are they double entering into yours?
Outside of oncology, most sites use paper charts instead of their EHR system to record source data because most EHR systems are not well suited for research workflows. In fact, CRIO’s third party survey data shows that less than 20% of research sites across all types (including academic centers) utilize their EHR system as a source data capture tool.