COVID-19 Expect the unexpected
Helén Johansen Blanco, head of clinical operations at Oncoinvent, discusses risk management versus issues management when dealing with the unexpected.
Islandic volcano Eyjaf allajökulls erupted in 2010, and fl ight transports and delivery of drugs to a site was aff ected to a high extent, which led to a focus on proactive risk assessment. What is truly unexpected? Could we have anticipated the Covid-19 pandemic somehow or could we, at the very least, have foreseen the consequences? Many companies off ered support and solutions on how to deal with the pandemic consequences. The best and most realistic to implement was received exactly fi ve weeks after hospitals had opened up for recruitment to clinical trials and external visitors. This then raises the following question: when does a risk turn into an issue? And how is the transfer adequately managed? This article will attempt to answer
T
he Covid-19 pandemic has highlighted the need for knowledge when dealing with the unexpected. Many will recall when the
a few of these questions; the purpose is not to provide answers in full, but to create a debate in order to improve the management of risks and issues in the long run.
Mitigate risk before it becomes an issue Literature within the fi eld of project management describes that the most successful projects are those where the team was acting in a proactive manner. Although this is often set by the leadership style of the project manager, everyone can adapt to a proactive way of working by establishing robust processes for risk management. Having a standard operating procedure in place for risk and issue management; describing frequency of risk assessment; cross-functional involvement; assessment of risk score by rating impact and likelihood; and following up of proactive actions to reduce risk – either by impact and/or likelihood
80 | Outsourcing in Clinical Trials Handbook
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