Running a tight ship The importance of not leaving outsourcing outcomes to chance. WORDS BY Anna Lukyanova
10 | P H A R M A FI EL D.CO.U K
hen biotech and pharma organisations outsource activities that are seemingly less ‘critical’ than the running of clinical trials, it’s too easy to neglect the importance of tight project management and stakeholder coordination to keep delivery on track. Whether the processes are around international pharmacovigilance or regulatory information management and filing activities, it is essential to ensure that outsourcing outcomes are not left to chance. In a clinical trials context, the need for tight project management is selfexplanatory, especially when entrusting the operations to a third-party research organisation. Keeping strict control over quality, process, resourcing, data management, audit trails and cross-party communications is essential to the success and credibility of outcomes, the management of costs, and the containment of risk. But move outside of clinical research, and biotech and pharma organisations quickly become more lax in their expectations of formal project management. If they are outsourcing processes such as pharmacovigilance or regulatory submissions management, firms’ chief priorities tend to be buying in particular technical prowess and access to scalable resources, placing all emphasis on the
relevant technical expertise and capacity of the teams they are engaging. Yet this preoccupation with the technical logistics can come at a price. While it goes without saying that service providers must be expected to field qualified talent with relevant experience of processing the given type of work, these qualities alone do not guarantee an optimum and tightly managed engagement. Trained scientists don’t necessarily make for natural project managers or communicators, so there is always a risk that the ins and outs of successful process coordination could suffer if there isn’t a designated person or team to bring all of the different strands together. STAYING ACCOUNTABLE
Often the project originator may underestimate what’s involved, as what seems to be a straightforward process is transferred to the outsourced service provider. If the brief is to deliver pharmacovigilance (PV) case reporting for 30 countries, for example, their primary objective will be to identify PV experts in sufficient supply. But by neglecting to vet the surrounding provision for coordinating ongoing communication with internal and external stakeholders (including business development people, technical teams, external vendors, contract/procurement departments, HR and even accounting and finance), any number of issues could emerge which – unchecked – could lead to project scope creep, missed deadlines, exceeded budgets and more. No matter how well defined an initial project is, requirements and other parameters will frequently change across the delivery lifecycle.
CSOs and Outsourcing