Enhancing Communication Between Clinical Trial Sites and the Central Lab During a Global Pandemic
The onset of the COVID-19 global pandemic has disrupted nearly every process for executing a clinical trial, from personnel restrictions and safety measures to the cancelation of flights that typically transport specimens to and from locations. It is more critical than ever to have effective communication between the central lab and clinical trial sites as miscommunications can have a disastrous impact.
Without clear communication between the site and the lab, specimens could be delayed, stored incorrectly or lost in transit. PPD® Laboratories’ central lab has been working diligently to enhance communication between the lab and clinical trial sites to ensure that studies continue and therapies are delivered to the patients who need them.
Two experts from our central lab, Melissa North, director of global site services, and Els Pluymers, executive director and site head of our central laboratory in Brussels, Belgium, discuss how PPD Laboratories has been leveraging the Preclarus® lab solutions to navigate the uncertainties that COVID-19 has brought on the clinical trial industry.
Q: How has the pandemic impacted PPD Laboratories’ central lab study sites?
Els: PPD has been closely monitoring the global conditions surrounding the COVID-19 pandemic. Several areas have been impacted, but logistics more so than others. There is a limitation to accessibility of sites, flight restrictions and cancellations along with local government action.
Q: How is PPD Laboratories adapting to the changes presented by COVID-19?
Melissa: Our logistics team has been working around the clock to react and adapt to changes, couriers are providing daily general and country-specific updates, and PPD has opened a constant stream of communication with our internal project management teams to keep them up to date on the latest changes. PPD has also extensively planned for contingencies, including involving other commercial airlines, extending our road network, redeveloping shipment routes, and sourcing private air charters to ensure that specimens are being transported properly.
Q: How has the lab been communicating these changes to clinical trial sites?
Els: At PPD Laboratories’ central lab, we leverage our Preclarus data solutions, primarily the investigator site portal, to effectively communicate changes that may impact specimen/supply shipments to our sites through news alerts. We also have the ability through the investigator site portal to post documents that outline important information for the sites. In addition to leveraging data solutions for enhanced communication, we have been directly communicating with our sites on various issues, such as how to properly package known or suspected COVID-19 positive samples to ensure the safety of our staff and couriers.
Q: How else has the Preclarus investigator site portal helped sites navigate these unusual times?
Melissa: Now, more than ever, simplifying tasks for clinical trial sites is crucial. The Preclarus investigator site portal reduces the burden on sites by streamlining clinical trial activities such as patient registration, data receipt, and responding to queries. Other benefits of the Preclarus investigator site portal include supply order tracking and specimen shipment tracking so sites can stay in touch with incoming and outgoing shipments during today’s erratic shipping environment. With the critical and urgent nature of COVID-19, specimen chain of custody has never been more important. The investigator site portal’s electronic lab requisition (eReq) connects patient and specimen information to the bar code at the time of collection, thereby establishing chain of custody before the specimen is shipped to the central lab. The tracking tools within the portal maintain the chain of custody through the life of the specimen. The portal also provides access to lab test results 24/7 to help ensure patient safety during the trial.