TrialKit Technical Specifications
With 10 years developing and validating our eClinical platform with thousands of clinical-stage companies, let us focus on the technology so you can focus on research and patients. Our team has extensive clinical domain knowledge and are experts at developing the software, so let’s dive into the technical specifications.
Global Compliance/Security
- Over 250 configurable role-based options to define user roles and access to data for site personnel, sponsors, CROs, study teams, and study participants
- Software and data center compliance with 21 CFR Part 11 guidelines, GDPR, HIPAA, EMEA Annex 11, ICH Q9, ISO 9001:2015, ISO/IEC 27001:2013, SOC Type 2, Privacy Shield EU-US, and HiTrust
- Compatible with all modern web browsers and mobile operating systems
- Disaster recovery, data backups, redundancy, fail-over features with guaranteed 99.7% uptime
Accessibility/Ease of Use
- Deploy TrialKit using a BYOD approach, available as a downloadable mobile app for iOS and Android devices, to eliminate the costly need to provision devices to sites and study participants
- Use biometric technology (i.e., Touch ID and Face ID) to login to TrialKit through compatible smart devices and enable two-factor authentication
- Multilingual, end-user-defined interface (currently available in 15 different languages)
- Single sign-on (SSO) enables access to an unlimited number of studies in one place
Infrastructure/Hosting
- Centralized, cloud-based platform hosted by AWS providing compliant, secure, and reliable connection to all data determined by client-administered security rights
- Hosting centers are located strategically around the world
- Ability to host a cloud database anywhere in the world. This is critical in certain cases where data privacy laws require data to be maintained within a certain geography
- Private server option – A private cloud environment is available to organizations who would like a customized, dedicated hosting environment within the CDS hosting ecosystem within Amazon Web Services
- Multiple clouds can be synchronized in accordance with the needs of a specific study or program of studies across geographic regions
- White/private label option – Enlist CDS to set up, configure, and deploy a client-branded version of the TrialKit mobile app (i.e., white-labeled) that clients can offer as their own downloadable app from the App Store and Google Play
Data/System Integration
- Fully documented, modern RESTful API enables the integration of data to/from any external system or database for external integrations (i.e., EDC, eTMF, CTMS, IRT, or imaging system)
- Integrate with third party data sources to pull data from wearable devices, electronic health records and any Bluetooth-enabled device (implants, sensors, etc.)
Technical Support/Help Desk
- Real-time support (24×7)
- 24×7 help desk support available via email and online request
- Live technical support available during normal business hours (8AM EST-5PM EST)
- Live, hands-on study setup and configuration support during the first 90 days of enablement for any new implementation
- Searchable, context-sensitive help available within the TrialKit platform via self-service model
Training
- The simplicity of the TrialKit platform enables users to be quickly up and running in less than one day, allowing them to be self-sufficient and able to navigate and perform their job-related activities in TrialKit with minimal training
- TrialKit was purpose-built to maximize the reuse of existing data, eliminate programming, and limit the need for frequent training and support
- Access to an extensive library of online, self-service training tools including a searchable knowledge base, videos, and training wizards
