Repeatable processes, with continuous improvement and secure document exchange with high visibility of progress to regulators, sponsors, and investigators are at the core of Site Activation. While there are generic technology solutions in the marketplace our client wanted to build Study Start-Up Expertise into any tool and use country-specific workflows to further streamline the processes. Our job was to select a solution fitting the requirements and then develop an execution plan for enterprise-wide rollout (to over 600 internal users and 7,000 external sites).
What we did
We followed a standard “product selection, pilot, business case, execution” model. The product selection phase filtered 6 respondents down to 1 which we brought forward to a pilot phase. The pilot phase was key as we were dealing with an innovative solution and had to prove that the solution worked in practice before investing in a wider rollout. We managed the pilot phase and ensured the focus remained on business benefits realisation and proving all aspects of the selected vendors’ offering. In parallel to the pilot, we prepared a business case for the board. This included leading contract and pricing negotiations with the third party as well as working with the business teams to refine business benefits and plan staff re-organisation. The business case was of the order of $10million investment with over 90 staff redeployed to value-added tasks as part of the benefits plan which formed part of a 2-year execution plan for global deployment as part of our presentation.
The Business Proposal was approved and we have been retained to manage the execution and rollout of the new solution. This is currently underway and tracking ahead of schedule, with early benefit realisation a feature of the rollout.