The Newcastle Joint Research Office (NJRO) is to digitise operational processes to improve the quality and operational management of clinical trials.
The NJRO is working with software firm Ideagen to implement Ideagen’s Q-Pulse quality management software, enabling them to move away from paper-based and manual processes.
Lesley McShane, Information Manager at the NJRO, said Q-Pulse – which is already in place within several departments at Newcastle Hospitals – will provide them with a robust system for quality.
She added: “Following an MHRA audit we identified several areas where we could improve regarding our operational and quality processes, particularly in how we manage non-conformance, document control and auditing.”
Gill Robson, Quality Assurance Manager at NJRO, said: “Managing serious breaches is going to be a particular area of focus. It’s a very specific term under GCP, which governs our research activity, and is basically something that has the potential to impact on the data generated by the trial or cause harm to a patient.”
Gill added: “Q-Pulse will play its part in accountability and provide evidence that processes and protocols for the investigation and recording of such events were followed correctly.”
The NJRO is a partnership that bridges researchers in both Newcastle University and Newcastle Hospitals supporting the joint development, implementation and successful delivery of world-class research.
Lesley McShane, Information Manager at the NJRO, said having all its data in one central and electronic location was a priority of the project with Ideagen. She continued: “Once the system is up and running we will witness great benefit both from a regulatory perspective and an operational one.
