Helping a global biopharmaceutical company to simplify their clinical development processes

Within a strategic transformation project, a global biopharmaceutical company asked us to create a single, streamlined  set of clinical development processes which could be applied consistently within their biopharma business division. The division develops pharmaceuticals and vaccines across a range of therapeutic areas. Their current processes were duplicative and overly complex, resulting in frustrated internal and external stakeholders, extended development timelines, and costly delays to commercialisation. Not only were they falling behind competitors, there were also regulatory compliance and patient safety risks. We needed to simplify their processes to improve performance, morale and mitigate these risks.

We cut complexity and involved people in the process across every division of the business

The project was sponsored by the Head of Development, and we engaged 2,000 people globally across 15 departments including research, commercial, medical and development. We understood that in complex organisations, all functions and processes are inextricably linked. To grasp where the problems lay, we interrogated these links to see which areas beyond processes might need reviewing. Were there problems with governance? Were their systems helping or hindering? Was it clear who was required to do what? We assessed the current situation, then mapped their ideal processes, and specified individuals and departments to own them. To streamline the rollout of the new processes worldwide, we made sure that local and regional offices would also be able to adopt them. 

Transformation projects of this kind can be daunting and last for years. They involve large scale and disruptive change affecting thousands of employees. Recognising this, we involved and engaged throughout our work. We produced training which helped people understand why they were doing things not just what to do and explained which roles would be affected. We ran early adoption pilots of the changes for some pivotal processes and adapted our implementation approach with the feedback. We rotated and refreshed our team and the client’s team to avoid project fatigue. And we built the capabilities, mindset, and behaviours needed to make the changes sustainable after the project finished. 

Clinical development times cut by 50% and a 60% reduction in paperwork 

With the processes we designed in place, our client has reduced the documentation they rely on by 60%, and cut their timeframe for running clinical trials by 50%. Teams across global functions and from affilitates all over the world are working to the new, simplified processes. We are now working with the client on further projects, developing better understanding of what patients want and need and defining evidence strategies and integrated evidence plans which meet the needs of numerous stakeholders and rapidly shifting and distinct healthcare environments. 

Find out how we help our clients in Pharmaceuticals and Life Sciences