To ensure the safety and integrity of our clients’ data, ClinDatrix has invested heavily in proven and proprietary systems for clinical research. We also employ a staff of IT specialists to sustain the validation, reliability and functionality of our systems.
We dedicate significant resources to our technology because it is the foundation of our business. The systems listed in the left navigation pane have the power and flexibility to handle small to large amounts of data as well as simple to complex study designs. All systems are hosted in a secure environment. Click the data sheet in the left pane for a list of key features.
Quality Assurance
The equipment and systems selected by ClinDatrix are implemented in accordance with good scientific and technological practices. Our fully validated (IQ/OQ/PQ) clinical research systems provide a secure, parallel processing environment that meets all regulatory agency requirements. All validation documentation is available for client review by appointment at ClinDatrix headquarters.
Change Control
All the computer systems that manipulate clinical data are called “GxP” systems and are under Change Control. Change Control procedures rigorously follow an SOP with forms required to be approved in writing before even minor changes, such as disk or memory changes, can be made. Even Windows security updates to GxP servers at ClinDatrix are under Change Control.
System Safeguards
ClinDatrix maintains fully secured facilities within a professional class office building in the Irvine Spectrum in Irvine, CA. The two-story building is securely locked after business hours and patrolled at night and on weekends by a security company. We assure the safety and security of our offices, file room and servers via SOPs and strict company practices. Our working environment complies with Good Clinical Practice and is a validated systems environment per FDA regulations and guidance. Our GxP systems are governed by documented change control.
Our network infrastructure management includes defined SOPs, software change control and system validation support. We also have a disaster recovery site at a data center 240 miles from our facility, and we sustain an active disaster recovery planning and testing program.
