Contract Services / CRO LIMS
Externalization of Research and Specialization of Capabilities Require New Methods of Data Management & Communication
As organizations take advantage of outsourcing trends to reduce costs and timelines, and focus on their specific expertise, new challenges have arisen – especially around CRO data management and communication. Sharing and collaboration are key to successful outsourcing partnerships, but the appropriate distribution of information is still difficult.
The Core LIMS enables labs to communicate securely, with granular user permissions to ensure that the right people have access to the right information. The Core LIMS also allows information and analysis to be shared in real-time, due to its 100% web-based browser interface. Current Core LIMS customers user the system to manage data and relationships for multiple CROs internationally.
Benefits of the Core LIMS
to Contract Services Labs:
SOP & protocol management
Inventory, storage management
Customized automatic & ad hoc reporting
Data security & integrity
Integration with third party systems (ERP/HR/MRP etc.)
Instrument integration for data collection automation
Automatic results reduction & flagging
Automatic alerts based on thresholds, authorization, publishing
Instrument management (calibration, maintenance, scheduling)
Sample management (login, registration integrity, life cycle tracking, etc.)
Chain of custody
Randomized sample set creation & testing
Lot & batch management
Work allocation & scheduling to reduce bottlenecks
Analyst certification management
Electronic document management
Barcode, RFID compatible
Regulatory compliance with US FDA Title III of the Public Health Security and Bio-terrorism Preparedness and Response Act of 2002, HACCP, GLP, GMP, CFR Title 9, 21 CFR Part 11, FSIS Directive 10240.4, etc.