We typically start detailed planning efforts 1.5 years before submission. We optimize plans on a continuous basis with all internal stakeholders, ensuring every step of the process is crystal clear, all the players are fully briefed and on board, and that no detail is overlooked.
Critical steps and handovers are scrutinized. Processes are piloted where possible, plans are de-risked and scenarios outlined as needed. We develop and visualize submission related processes well before the last patient’s last visit, to enable fast execution up to submission.
Where needed, we develop cross-functional processes (e.g. review and approval of submission documents), integrating all functional plans to ensure visibility across functions and create awareness throughout the organization.
We optimize plans cross-functionally to enable key stakeholders to deal with multiple deliverables in a parallel setting, ensuring resources are in place and everyone knows exactly what to do, as well as monitoring the execution of the plan, planning for lessons learned and integrating findings into optimal submission processes.
ImprovementatWork has the expertise and experience you need to fast track your submission to success. We bring in our toolbox and best practices from previous experiences, and work with teams to come up with practical, workable solutions for your company’s specific situation. We ensure teams are absolutely prepared for the challenge ahead. We don’t do it to you, we do it with you. And that’s what makes us unique.