IN PARTNERSHIP T
here are issues and limitations that exist around laboratory resources, organisational structures, laboratory
information systems, quote and invoicing structures, leadership, and communications. Here, Nan Zhang MD PhD discusses some of the tactics and opportunities that can help a laboratory become more aligned internally and externally to better satisfy the ever- changing requirements of clinical trials.
How can a laboratory better align its employees and resources considering global resource constraints? “The average lead time for analytical and/or months in today’s laboratory CRO (contract research organisation) market. This is most likely due to growing market demands, disruptions in the supply chain, employee turnover and relatively slow hiring and training processes. Even though an offboarding checklist is followed in many laboratories, where all the details can be adequately transferred to the person taking over, leaving gaps in the project. Because it is optimal for a clinical trial project to maintain a stable and focused workforce to support it, the laboratory CRO that best aligns with employees’ overall interests as a human will be able to retain the best talent and win. “Proactive supply chain management is critical for success when using a central laboratory. Supply chain security requires increased diligence when diversifying supply chains. Several strategies have been proven
“For any service that requires continuous efforts daily, a minimum of three personnel is needed. When one project manager is on vacation, and a second happens to be sick, at least there is a third PM to ensure project continuity”
to be effective in mitigating supply-chain risks, including: •
• instituting a supply monitoring system •
transparent and collaborative supply chain planning
• decentralising an ample supply of common lab and logistical supplies • supply sharing between sites.”
How is a team-based client-interfacing project management structure better aligned with laboratory project continuity? “Minimising project manager([PM) turnover and cultivating expertise in specialised sample management are two critical aspects to ensure a seamless operation and correct handling of specimens. A capable PM can oversee lab and specimen-related activities and issues. For any service that requires continuous efforts daily, a minimum of three personnel is needed. For example, when one PM is on vacation, and a second happens to be sick, at least there is a third PM to ensure project continuity. “In many laboratory CROs, typically only one client-interfacing PM is assigned to a single project at a time. Over time, the same PM may be assigned to multiple projects. If that PM is on vacation or sick, it is very hard to ensure continuous delivery and oversight of the project. PMs with a superb sense of responsibility cannot fully rest during their vacation if no backup is provided. In the long run, PM burnout is inevitable. As one PM is generally assigned to multiple projects, there will be a collision of concentrated deliverables between multiple projects, and the PM will be unable to ensure prompt delivery of work. All of these issues arise from a lack of a structured project management service. “Over the years, we’ve learned that a structured client-interfacing project management unit is more effective in ensuring project continuity, balancing workload and preventing PM burnout. The implementation of a team- based project management approach to oversee the process and support staff, as demonstrated in Figure 1 (see page 12), is superior to the traditional single PM model. For each clinical trial project involving a fair amount of PM work, a primary PM, a back PM, and a supervisory PM are assigned to the same
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