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Remote Monitoring

See your clinical research sites’ source data, associated PDFs such as consents or labs, regulatory files, and delegation log, all in one place, online.

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Remote Monitoring
FOR SPONSORS

Remote Monitoring of CRIO Sites

Watch this short video to see CRIO’s system. You’ll see how easy and intuitive our eSource, CTMS, and eRegulatory system is for remote monitoring.

Overview of Remote Monitoring

Whether your visits are done in-clinic, at home, or virtually, you are responsible for oversight & source data verification. With CRIO, you can see your sites’ source data and associated PDFs (such as consents and labs), regulatory files, and delegation logs, all in one place, online. You can also generate queries that your sites can respond to. Everything comes with a 21 CFR 11-compliant audit trail, so you know who recorded what data point, when they did it, and why they made changes. Your CRAs only have to travel for IP reconciliation and face-to-face training and dialogue.

Minimize Safety Risk to CRAs and Research Site Staff

Minimize Safety Risk to CRAs and Research Site Staff

Save on Travel Costs and Time

Save on Travel Costs and Time

Gain Real-Time Access to Source Data

Gain Real-Time Access to Source Data

Centralize all Monitoring

Centralize all Monitoring

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Two Ways Sponsors Use CRIO For Remote Monitoring of Trials

CASE STUDY

1. Reimburse Your Sites For Using CRIO

We recommend that sponsors reimburse their sites for the use of CRIO’s system. We recommend $2,000 for eSource and $1,000 for eRegulatory. If you want assistance locating eSource-ready sites, please email us at sales@clinicalresearch.io.

Study Template Design

Design of eSource template; includes protocol amendments

Site Activation and Training

Activation and training of new sites (non-CRIO clients)

All Licensing and Maintenance

Use of eSource and eRegulatory during trial, with customer support

Electronic Archiving Post-Closeout

15 to 25 years electronic archiving of all records

2-4 Weeks From Start to Finish

We’ll design and deploy templates within 2-4 weeks

$3000 Per Site (With Volume Discount)

A simple flat low price; $2000 per site if over 20 sites sign up

2. Offer CRIO To Your Other Research Sites

We have a full-service offering where we can build the study template, as well as activate and train all sites on your trial, including sites new to CRIO.

CRAs Favor CRIO Over Paper

According to a third party survey of CRAs who have used the CRIO system, CRAs favor CRIO over paper by up to 3:1 margins

RESPONSES OF CRIO CRA-USERS

% Disagree
% Agree
7
77
The CRIO system is easy to use compared to other industry systems
15
67
Compared to paper, the CRIO system promotes data integrity
26
64
Compared to paper, the CRIO system facilitates my ability to perform thorough QA
15
56
Sponsors benefit if more sites use CRIO or a system like it
19
52
Compared to paper, the CRIO systems promotes protocol compliance
18
52
The industry is moving towards full eSource adoption within the next 5 years
% Disagree
% Agree
See Full Case Study

CRIO vs. Paper-and-Scan Remote Monitoring

Paper-and-Scan
Access
Immediate
When the site uploads
Legibility
Completely clear
Good luck!
Quality of Data
High (because of edit checks)
Variable
Querying
Online, in line with data
Offline, by email
Site Workload
Minimal
Tedious
Security
Encrypted & access controlled
Not secure

Recent FDA Guidance Supports Remote Monitoring

“If planned on-site monitoring visits are no longer possible, sponsors should consider optimizing use of central and remote monitoring programs to maintain oversight of clinical trials.”

- FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic, Mar 2020 (p. 8)

Sites are Able and Willing To Implement Remote Monitoring Technologies

“Nearly two-thirds of sites prohibit on-site monitoring.”

“91% of sites would utilize an eSource system furnished by the sponsor to facilitate remote monitoring”

- Results of research site survey administered by CRIO on 19 Mar 2020

Learn More About CRIO

BOOK A 20-MINUTE DEMO TO LEARN ABOUT OUR PRODUCT