Managing Bioanalytical Studies During the COVID-19 Pandemic: An Overview

Abstract

In this time of crisis due to the global COVID-19 pandemic, most people are staying at home to slow down the spread of the virus and the resulting pressure on their healthcare systems. This is either because of a governmentordered lockdown or self-imposed quarantine. The extent of the measures differ country-to-country and state-tostate. Where companies are allowed to stay operational or where bioanalytical laboratories are regarded part of the essential healthcare infrastructure, bioanalytical studies can still continue. Most laboratories have reduced the presence of office staff in their facilities to the absolute minimum. This includes management, project managers, study directors and supporting staff. In order to ensure continuation of the bioanalytical work, especially those which directly impact the safety of volunteers and patients in clinical studies and those which are done as part of the fight against the COVID-19 pandemic, the laboratory analysts and essential facility staff are allowed to come into the laboratory.In this editorial, we would like to give some attention to the measures taken to minimize the chance to spread the COVID-19 virus and the impact this has on the analysts working in our laboratory and the study managers.The following roles of the study manager apply: study director (SD) or principal investigator (PI) in studies with a GLP claim or the project manager (PM) in a study where samples from a clinical trial are analyzed good clinical laboratory practice (GCLP) as single point of control. General measuresNext to general preventive measures such as disinfection of the hands upon arrival in the building, we have done everything possible to ensure the recommended social distancing of at least 1.5 m in our laboratory in Assen, The Netherlands. As samples are always considered potentially hazardous and are handled as such, no additional preventive measures have been implemented for handling samples from volunteers that are not suspected to be infected with COVID-19. However, samples from volunteers suspected to be infected with COVID-19 are analyzed in our BSL-2 biohazard laboratory. Impact on the laboratory analystsDuring the critical steps of the sample preparation process at the bench in a laboratory, it can become crowded at times, so work shifts have been initiated by the analysts to decrease the number of colleagues working at the bench at the same time. The number of work places at each bench has been limited and plexiglass plates are placed between the work spaces for protection. Contact between the departments is minimized by the use of separate entrances and staircases. Now that most office staff are working from home, the analysts are spread out over the building. This includes not just the normal administration rooms of the analysts, but also in meeting rooms and offices that are currently not in use, to perform data processing. This allows us to keep a safe distance. Awkward situations may arise in the corridors, which are 1.5 m wide. Colleagues stand on the look out until th...

How the Covid-19 Pandemic is Changing Clinical Trial Conduct and Driving Innovation in Bioanalysis

“…With lockdowns and travel restrictions, testing facilities were faced with unprecedented challenges. Entirely new ways of working have been developed as scientists moved to virtual platforms whenever possible to enable working from home [ 35 , 55 ]. Remote operation of instruments, electronic document signature, increased automation and virtual meetings were increasingly utilized to reduce the number of people in the laboratories.…”

“…Remote operation of instruments, electronic document signature, increased automation and virtual meetings were increasingly utilized to reduce the number of people in the laboratories. Virtual audits have become commonplace [ 55 ]. The balance of remote and in person work may shift in the coming years as companies and researchers find an equilibrium that optimizes productivity, scientific achievement and work/life balance.…”

Managing Bioanalytical Studies During the COVID-19 Pandemic: An Overview

“…How would that affect working remotely? According to the Organisation for Economic Co-operation and Development (OECD) GLP principles [1], the study director has the overall responsibility for the conduct of the study and for its final report at the test facility or the principal investigator at the test site. The phrase "responsibility for the overall conduct of the study and for its final report" may be interpreted in a broader sense for those studies where the Study Director may be geographically remote from parts of the actual experimental work.…”

Bioanalytical Research and Training in Academia During the COVID-19 Pandemic

“…In the past few months, governments have imposed unprecedented measures to halt the spread of the coronavirus, and these measures continue to impact daily lives and societies while also business operations and the economy in general. The field of bioanalysis is one of the many fields facing changes and challenges in the current crisis, which, fortunately, do not all strictly have a negative impact on laboratory operations, as was recently discussed by Pruim and Teekamp [1]. This article highlighted some of the impact on an industrial bioanalytical setting, and here we aim to complement their work by elaborating on the impact of the COVID-19 pandemic from the perspective of bioanalytical research and training in an academic laboratory.…”