It’s all too easy to underestimate the importance of tight project management when the work being outsourced is something other than clinical trials. Yet, whether the processes involved concern international pharmacovigilance or regulatory information filing, Anna Lukyanova, COO of Arriello, warns life sciences firms not to leave outcomes to chance.
Project management
Keeping strict control over quality, process, resourcing, data management, audit trails and cross-party communications is essential to the success and credibility of outsourcing outcomes, and critical to the management of costs, and containment of risk. This is true not just in a clinical trials context, but for all engagements.
In a research context, the value of tight project management is self-explanatory when entrusting the operations to a third party. Yet when it comes to more routine requirements, biotech and pharma organisations tend to lower their expectations. For (PV) pharmacovigilance, or regulatory submissions and associated information management, firms’ priorities typically revolve around specific technical capabilities and capacity, rather than how the engagement will be coordinated and delivered. If the brief is to deliver pharmacovigilance operations for 30 countries, for instance, the chief aim will be to ensure the partner organisations has PV experts in sufficient supply.