Innovation is at the heart of everything we do. Today, CRIO serves 600 client sites worldwide in 12 different countries across the globe (United States, Canada, Mexico, Brazil, Panama, Chile, Germany, Ireland, United Kingdom, Russia, South Africa, and Australia). Since most trials are global – and given the myriad regulations and privacy concerns surrounding Protected Health Information (PHI) – CRIO continues to develop a global infrastructure that can service anyone, anywhere.
Research is a global endeavor and the move towards remote monitoring is now happening worldwide. Sites all over the world have been successful with CRIO. We continue to build our global community of users, and together, we’re moving research forward.
CRIO’s fully stacked software complies with the major global regulatory standards governing clinical research, including 21 CFR 11, EU Annex 11, GDPR, HIPAA, and China’s Personal Information Security Specification. Our rigorous policies and procedures satisfy local regulators. CRIO has been validated by outside experts and has third party attestations on 21 CFR 11, EU Annex 11 and GDPR compliance.
All time-stamps on the audit trail are displayed in the local time zone, as set by the site. The CRIO system automatically updates the stamps if the site changes the time zone.
With CRIO, sites can manage a financial portfolio spanning multiple currencies. Sites can specify the currency which the study sponsor uses to reimburse them, the currency in which their own vendors are paid, and the currency in which they pay their patients.
English and Portuguese language options are currently available. However, for electronic source data, sites can design questions and answers using their local language.
CRIO’s VOIP/ Texting feature is supported in major geographies. Support information and a complete country list is available here.
We have simplified date formatting and are transitioning from U.S. style dates (1/1/2021) to the clinical style format (1 Jan 2021).
CRIO has developed a network of geographically dispersed servers to host our system with servers in the U.S., Canada, Germany, Australia, and coming soon, China. Data stays resident in that country, including off-site back-ups. PHI does not leave the particular country, satisfying local regulations that prohibit transmission of PHI to other jurisdictions.
Decimals in currencies are set to period or comma, per standard.
Customer support is currently offered from 9 a.m. to 9 p.m. EST Mon-Fri (ending at 7 p.m. EST on Fridays). 24-hour live customer support is coming soon. For sites operating outside of support hours, we strongly recommend a “super-user approach” – designate a subset of users to become platform champions to act as internal support.
Our system has settings that allow our sites to support local workflows. This includes a data consent workflow for the EU. Sites can keep track of patients’ consent to store their personal information in the recruiting database.
Sites can track patient stipend payments, regardless of currency.
“With CRIO, our HQ does all the study setup, regulatory and financial management, while our partners complete the eSource templates in Spanish. CRIO was so easy to use and took very little time to get up and running.”
“I use CRIO because there is no service like this in Brazil. An option of electronic source document in Portuguese with an automatic multi-currency financial platform is something that facilitates the clinical research activities in a complete and innovative way. With CRIO, we have been able to build out hubs across Brazil and bring research to underserved areas.”
“We chose CRIO because we can customize it to suit our workflow, it is easy to use, and the billing is structured in a way that makes it economical for small clinics as well as large.”
“At Atlantia, we use CRIO as our CTMS for both our Chicago and our Cork, Ireland research sites. It is efficient and provides us with the exact information we need to run our studies seamlessly.”
“CRIO has been an enormous advantage for us. The system is easy to use and we have a great support from the team. This kind of electronic system is a great tool for studies. Web based access allows some staff to work from home – the savings are substantial.”