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, organization and supporting technology.

From a process point of view, it was evident that AE case handling process at the organization 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 data that was 'right first time' and the process metrics and data in place did not enable easy root cause analysis and continuous improvement.

The existing organization structure and roles did not promote efficiency or accountability resulting in poorly defined roles and responsibilities, and a lack of staff development towards current and potential roles.  Roles that shared case processing responsibilities were structurally separate.  Drug Safety and Pharmacovigilance were operating too close to maximum capacity, and the mix of permanent to temporary staff was not optimal.

Use of supporting technology was limited.  Technology inputs, outputs and in-process deliverables were created manually, in-house tools were not fully utilized to support workflow, electronic case processing or metrics generation.

WCI were engaged based on their 'excellent reputation in the Drug Safety area'  said the Executive Medical Director, to assist the organization in their process improvement project and to deliver the necessary solutions to the following objectives:

1. to support the development and implementation of a streamlined AE process

2. to support the redesigned AE process with a new organizational structure; aligning roles, responsibilities and skills

3. to leverage available technology to support the change management programme.

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

Ensuring Compliance whilst improving operational efficiency and organisational capability

For further information please contact Kate Adams at kate.adams@wcigroup.com