IN PARTNERSHIP
Figure 1. Structured project management organisation structure to better align with project continuity and delivery
project. Within the same PM team, associate PM and PM assistant are taking important lower complexity tasks to ease the burden of the primary PM. As these client-interfacing PMs are involved in protocol analysis, lab manual creation, lab activity monitoring, and other study-related document generation, each step in the process is engineered to be nimble and
How can laboratories mitigate the risk of communication breakdown between different laboratory subunits/sites? “Even though laboratories are all working on the same topics, various laboratory sub-units or sites frequently work in silos. One of the most prevalent problems encountered when conducting laboratory CAPA (corrective and preventive actions) root cause analysis is communication breakdown. Due to inadequate infrastructure and communication cadence, many people feel working within one laboratory is like dealing with different companies when a project affects multiple laboratory sites and/or business sub-units. Suitable channels for communication should be used, such as regular alignment meetings across business units/laboratory sites, emails, chat programs like Microsoft Teams, and project management software. Internally, involving all stakeholders and providing regular project updates are crucial steps. Alignment within the same easier than vertical alignment (project-based) globally across multiple BU or sites. An important step in achieving effective project-based
26 | Outsourcing in Clinical Trials Handbook
alignment is the establishment of a suitable organisational structure for the purpose of aligning interests and establishing positive
How can laboratories better align with adaptive designs of clinical trials? “Adaptive designs can make clinical trials more flexible by utilising results accumulated in the trial to modify the trial’s course according to 1
Adaptive design trials
because they make better use of resources such as time and money and may require fewer participants. “The problems with the adaptive design of clinical trials include the constant need to revise lab manuals, kits, laboratory testing, and schedules, as well as the plethora of change orders and their timely turnaround requirements. The trials are more likely to be effective, instructive, and ethical if they are conducted in a laboratory that is aware of the need and is equipped to deal with it. Building an infrastructure to enable quote and invoice automation will drastically reduce the turnaround time of quotes and change order generation, and invoicing. “Changing an existing study protocol often leads to more mistakes in the lab since it is ensure that all the desired outcomes are achieved. A change control standard operating procedure (SOP) and checklist should be used to ensure that all changes are implemented
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