Reengineering Clinical Operations

A global vaccines company had reached the point where the scale and complexity of its clinical development portfolio had outgrown its operating model. The processes governing CROs, study start-up, and protocol development had accumulated over years rather than been designed, and the contracts underpinning those relationships were transactional rather than strategic. The organisation needed to rebuild its clinical operations function from the ground up — not just streamline it.

We led the transformation of Clinical Development Operations end to end: designing the operational processes for CRO management, study start-up, and protocol development, and helping develop and implement multi-year strategic contracts with CROs, study sites, providers, and health systems. The work required both deep process design and careful change management — the new model asked clinical operations staff to work in fundamentally different ways and to manage partner relationships with a level of strategic discipline that had not existed before.

The transformed function gave the organisation a platform for running more trials with greater efficiency and more predictable timelines. What drove the outcome was not just the new processes but the investment in helping people make the transition to them. Reengineering without adoption is redesign on paper. Getting both right is what turns a transformation into a lasting operating improvement.