Instructions
Crucial Data Solutions maintains compliance with the following guidelines:The TrialKit platform is a product of Crucial Data Solutions, a U.S. corporation. TrialKit is used as a pharmaceutical and device data collection tool around the globe in all phases of research, post-market studies, and registries. In ongoing efforts to protect the integrity of data and maintain robust up-to-date security, Crucial Data Solutions follows several regulatory guidelines and modern scalable cloud environments for its data.
Regulatory Guidelines
US Food and Drug Administration US 21 CFR:
Part 11 – Electronic Records; Electronic Signatures
Part 312 – Investigational New Drug Applications
Part 820 – Quality System Regulations
HIPPA HIPAA - Health Insurance Portability and Accountability Act of 1996
...
GAMP 5 – A Risk-Based Approach to Compliant GxP Computerized Systems
GDPR – General Data Protection Regulations – EU Directive 95/46/EC
ICH E6 R1 - Guideline for Good Clinical Practice – CPMP/ICH/135/95
ICH E6 R2 - Guideline for Good Clinical Practice - Integrated Addendum
ICH Q9 – Quality Risk Management
ICH Q10 – Pharmaceutical Quality System
ISO 9001:2015 – Quality Management Systems
ISO/IEC 27001:2013 – Information Security Management
SOC Type 2 – Service Organization Controls
Storage
TrialKit Cloud networking and data storage employ 3rd party services provided by Amazon Web Services (AWS) around the globe, for both primary hosting and data backup/recovery.
...
EU West - Ireland
EU West - Paris
US East - Ohio
US West - Oregon
Processing, Security, and Reliability
AWS is a well known and reliable provider of SOC and HiTrust-certified hosting and networking services. Read more about compliance programs here.
...