Andronovo Labs has made significant investment in an IT infrastructure suitable to deliver high-quality services within a demanding environment that will increasingly rely on innovative technology for better performance, data integrity and security. Our advanced information technology includes a portfolio of application packages that reflects leading industry standards as well as customized IT solutions – seamlessly integrated across all activities along the clinical development value chain.
IT security and IT quality – no compromises!
Our corporate policies and procedures ensure that we comply with international regulatory requirements set by the FDA, the EMA and national regulatory authorities. All phases of the System Development Lifecycle are covered by a comprehensive set of SOPs. All systems are validated and have been assessed for 21 CFR Part 11 compliance.
IT infrastructure: secure, private, reliable
- Andronovo Labs IT infrastructure maintains adherence to international regulatory requirements set by FDA, EMA and national regulatory authorities
- All IT processes are covered by comprehensive SOPs and QA audits
- All systems are validated and assessed for 21 CFR Part 11 compliance
- Secure authentication is enforced by a 2-factor login procedure. Secure data transmission is via dedicated private lines or virtual private network (VPN) tunneling and SSL encryption
Our clinical systems and data are hosted in an ISO-9001 / ISO 27001 certified data center with the highest security standards according to FDA guidelines.
Our clients and business partners can benefit from advanced network solutions such as:
- Electronic data capture (EDC)
- Remote access through a VPN
- Application hosting services
- Common shared or distributed databases
- Secure e-mail connection
- Communication platforms (SharePoint, secure FTP)
- Citrix MetaFrame technology and RSA authentication, which provides clients with secure and controlled high-speed access to our clinical, statistical and pharmacovigilance systems
Shared communication platforms
- Andronovo Labs SharePoint server is a Web-based communication platform that allows secure shared access to relevant documents, including project status information (based on Microsoft SharePoint)
- Andronovo Labs secure FTP server provides fast and secure access to raw data (e.g. CRF images)
Working on client systems
If you would like us to work on your system, our open network architecture allows us to meet your networking standards and security policies. Our staff is accustomed to working in a distributed environment, accessing client databases at various global sites as well as our own databases – all from a single standardized workplace.