Cambridge Cognition's technology is used to characterise the cognitive effects of new medicines, evaluating their cognitive efficacy and safety and assessing remediation of cognitive deficits. We are fully aware of the need to conform to GCP and so our software for clinical trials is designed to be fully compliant with industry standards to help your trial meet regulatory requirements such as 21CFR Part 11 and GCP. Cambridge Cognition was the first cognitive assessment provider to receive ISO certification. We have held this since 2006, and are currently certified to ISO 9001:2008 + TickIT.

CANTABelect contains as many of the CANTAB tests as required to meet the needs of your trial. The user interface is customised to meet your exact requirements, from collecting subject details (with custom validation) to data backup, and the software is supplied installed on the latest tablet PCs with touch screens. CANTABelect is a flexible software product designed to be extensively tailored to meet the needs of individual clients. Our pharmaceutical clients are provided with a validated system customised for data collection in their regulatory trial, supported by quality assured processes.

The operation of the software is fully specified to meet your needs, each custom deployment comprising a series of data input and verification screens arranged in a manner to suit your trial. The software is highly prescriptive of its users’ actions, and restrictive as to what data they may enter and in what format, with some screens being conditional on values previously entered. Likewise, the validation of data entered can be made conditional on previous choices made by the user. The intention is to minimise the possibility of error, to ensure the administration of the correct tests and to reduce the number of data queries subsequently raised.

Each customised version of the software undergoes a full software development life cycle approach, following similar principles to those outlined in the GAMP guidelines. A key document in the procedure is the user requirements specification, written and approved by both the client and the software development team, and the process culminates with a validation report. Our software is suitable for GCP compliant use.