Balancing performance and compliance we enable our clients to be more effective and efficient in drug safety

With in excess of 100 years in the industry our client is a leader in the development of long acting medicines.  With a five year plan in place to grow and expand the business, following the significant downsizing that had been previously endured, our client first had to address the need for a comprehensive review of its Drug Safety and Pharmacovigilance processes, organisation and supporting technology.

From a process point of view, it was evident that AE case handling process at the organisation were stretched.  Too many hand-offs and rework loops were adding to lead times and, as a result reducing compliance.  There was also unnecessary duplication of effort involved with legal cases, giving rise to significant workload.  The processes adopted by our client were not geared towards collecting quality incoming data that was 'right first time' and the process metrics and data in place did not enable easy root cause analysis and continuous improvement.

To read the case study in full, please click on the pdf link below:

Ensuring Compliance whilst improving operational efficiency and organisational capability.pdf