1) CDISC ODM Certified(Platinum Member)
2) ISO 9001 Certified
3) ISO 27001 Certified
4) FDA Part11 Compliance Assessment_Passed
5) ISPE GAMP5 Assessment_Passed
6) GS Certified for each solutions
1) Interoperability - Each solution interoperates and shares data, eliminating the repeated data input.
2) User friendly features - CRScube's solutions have grown with experience and feedback from the actual clinical trial site, equipped with various user friendly features.
3) Certified solution - CRScube's solutions have been fully assessed and certified to specific conformance requirements such as FDA's Part11, ISPE's GAMP5, and CDISC's ODM Certification.
E-mail inquiries on solutions are available 24 hours a day, and inquiry call center is available during KST(UTC + 09: 00) 09:00 ~ 18:00.
The emergency communication network is operated 24 hours in order to cope with the emergency situation, and related processes are specified in the internal SOP(Standard Operating Procedure).
It is managed 24 hours a day through the combined operation of IDC(LG U +, Located in Seoul, South Korea) and DR Center (AWS, Based in Singapore).
CRScube's cubsSolutions are used in more than 20 countries, with its abundunt multi-language features.
Following formats are supported.
1) XPT
2) SAS
3) Access
4) Excel
5) CSV
6) ODM
The initial fee is free, and the reasonable monthly fee is expected based on the phase and the number of subjects.
Yes, if you have an internet connection, you can use it anytime and anywhere.
All of our solutions are web services that do not require installation. Therefore, you can use it if you have only Internet connection.
We can support your external audit in case of system-related issues.
In addition, you would configure only a minimum level of internal SOP related to the system since CRScube's solutions are provided in the form of web service.