Quality and continual improvement in people, systems and processes are part of SQN’s DNA and is inherent in our technology too.
The latest release in March of Syne-clin, our EDC and trial management system benefited from the Kaizen influence with numerous new features and enhancements. Site monitoring, data validation and clinical oversight were enhanced with extended risk management and further minimisation of missing data.
Kaizen touched other areas of our business to the betterment of our clients and sponsor companies. Recently installed, our innovative, cloud based project management and project oversight system helps manage risk, resource, delivery and budgets; controlled proactive management with no surprises!
2016 saw SQN install DocuSign Electronic Signatureswith an enhanced 21 CFR Part 11 module. Improved process and cycle times have been realised with enhanced document security and management. Documented Kaizen benefits for SQN and sponsor interactions.
Legacy data can mean non-conforming data, not meeting data standard required by regulatory authorities and not meeting electronic submission data requirements. Kaizen thinking and technical enhancements are allowing significant benefits and support to data integration, analysis and reporting from disparately formatted legacy studies. Contact us if you are planning an ISS/ISE submission or simply wish to pool multiple legacy studies for exploratory analysis and support your development planning options.
In maintaining a framework for this continuous improvement SQN uses an electronic quality management (QMS) system – Ideagen Q-Pulse®. This system fully complies with the United Kingdom Statutory Instrument 2004 No. 1031 The Medicines for Human Use (Clinical Trials) Regulations 2004 and subsequent amendments, the International Council for Harmonisation Good Clinical Practice guidelines and the United States Food and Drug Administration Rule 21 CFR Part 11, Electronic Records; Electronic Signatures – Scope and Application.
Q-Pulse® gives SQN a centralised way of managing QMS documents and records, including all Process Maps, SOPs and forms, audits, non-conformances (Corrective Action and Preventive Action), training and training records.