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Quality Management System for Clinical Trials Unit
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Descriptions
The University of Exeter Clinical Trials Unit (ExeCTU) is undertaking this procurement process to select an Electronic Quality Management System (eQMS) for use over the coming years. Whilst ExeCTU have an incumbent system they are keen to engage the market and understand whether alternative solutions add further value in respect to operational needs. Such that the selected solution as an outcome of this procurement process will align with the sector’s best practice and strengthen their compliance profile to potential collaborators, which is absolute must in this sector.
The sought-after solution must comply with clinical trials regulation and Good Clinical Practice, and meet expectations of regulatory inspectors. In particular, it should provide robust functionality for managing the CTU’s Standard Operating Procedures and other controlled documentation. The eQMS software is utilized by up to 50 core users and with up to 3 users with full system admin rights to make amendments to the system set up. Suppliers should also be able to provide implementation support, ongoing training, and continuing system support.
Timeline
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Tender Regions
CPV Codes
48000000 - Software package and information systems
48612000 - Database-management system
72000000 - IT services: consulting, software development, Internet and support
48610000 - Database systems
48613000 - Electronic data management (EDM)
48611000 - Database software package
48614000 - Data-acquisition system
48100000 - Industry specific software package
48180000 - Medical software package
48170000 - Compliance software package
Keywords
IT consulting
data export tool
enterprise DBMS
web services
network support
cloud services
DBMS platform
IT systems
IT outsourcing
hospital IT solution
event-trigger logger
user privilege control
ACID transaction handler
database audit logs
software development
cybersecurity support
real-time data logger
NoSQL database engine
workflow routing engine
stored-procedure editor
application maintenance
version control manager
audit trail recorder
client-server database
medical software package
schema versioning tool
geodatabase platform
sensor data collector
data integrity module
replication manager
indexing optimizer
data migration utility
performance tuner
digital solutions
help desk services
enterprise software
digital transformation
technical support
digital record organizer
calibration data tool
records retention module
access permission tool
database schema designer
application software
electronic archive
SQL server platform
metadata tagging engine
data sampling scheduler
system integration
SQL query processor
software customization
compliance software
data replication system
backup/recovery manager
relational DB engine
packaged applications
acquisition protocol driver
relational database system
IT infrastructure management
database analytics engine
high-availability cluster
clinical information system
specialised enterprise software
instrument control module
measurement unit aggregator
high availability database cluster
telemetric input software
vertical market application
tailored industry IT solution
analog-to-digital converter interface
regulatory compliance system
concurrency control engine
content indexing software
industry-specific software
software package and information systems
transactional database system
distributed database software
corporate governance software
database security manager
document repository system
electronic patient record
standards adherence package
health management application
Tender Lot Details & Award Criteria
1 Tender Lots
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