COVID-19 – PCM TRIALS Business Continuity Plan

As the information around the novel coronavirus and COVID-19 continues to change rapidly, we want to assure you that the team at PCM TRIALS is monitoring the national Centers for Disease Control and Prevention (CDC) warnings and applicable State and Local Health Agencies daily. Because of our national presence, we will continue to monitor the guidance the CDC provides and coordinate our responses at the State and Local levels. We have also established an internal COVID-19 Task Force that is responsible for planning and executing our contingency plans in response to this pandemic.

PCM TRIALS Employees

We have developed plans to ensure that our business operations, including the project management of clinical trials and the support of our CMRNs, are not severely impacted by the current COVID-19 outbreak. PCM TRIALS has implemented contingency plans to facilitate working remotely and is practicing social distancing for those employees required to be in an office. PCM TRIALS employees will follow national guidelines as they are updated, based on their location, to ensure that our staff can continue to work safely. All PCM TRIALS employees are instructed to follow the CDC guidelines on travel.

PCM TRIALS Certified Mobile Research Nurses (CMRNs)

The safety of our nurses and trial participants is of paramount importance to PCM TRIALS. We are working with our CMRNs to ensure that they take the relevant precautions to protect themselves and the trial participants when performing home visits. We have provided gloves, masks and safety goggles to our CMRNs to enable safe interactions with trial participants during home visits. If, during the CMRN’s pre-visit communications with the trial participant, it is determined that the trial participant has symptoms of COVID-19, CMRNs are instructed to contact the PCM TRIALS Project Manager to indicate whether or not they will be able to conduct the scheduled visit. If a nurse declines to conduct a home visit, we will work to provide an alternative nurse or notify the site that a replacement cannot be found. CMRNs have been instructed not to conduct any home visits if the CMRN is symptomatic or has been diagnosed with COVID-19. If the CDC restricts travel to a particular geography, our CMRNs will follow that guidance and not be able to perform home visits. Sites will be notified at that time that home visits are not an option until the travel ban is lifted.

It is PCM TRIALS’ policy to have our CMRNs visit the CDC’s website regarding travel to determine if they should alter any travel plans. If they have travelled out of the country in the past 14 days, they are asked to follow the CDC guidelines for risk assessment and prevention activities and inform their Project Manager of any limitations to their ability to perform their duties safely.

Trial Subjects

PCM TRIALS will continue to conduct home visits during the COVID-19 outbreak, as long as there are no geographic restrictions imposed by the CDC. If a trial study participant feels that they may have been exposed to the coronavirus, they should contact the site directly and follow their instructions. Sites may refer trial participants to PCM TRIALS for home visits if travelling to the site will increase the trial study participant’s risk of exposure to the coronavirus.

Please contact your PCM TRIALS Project Manager if you have any additional questions or concerns.