COVID-19 Action Updates
COVID-19 Action Updates
Please know that our Executive Management Team, our Chief Compliance Officer and all Apex staff are taking subject and employee safety seriously. Below are some measures we’ve taken, with new initiatives daily as needed to address an evolving situation. Apex leadership has shared best practices for dealing with this crisis with our Alliance sites as well.
In this difficult time, our team is available to assist you in scientific, operational and administrative activities that will move project plans ahead for a full recovery.
Bobbie Theodore and Apex management
• Following current and frequently changing CDC guidelines while remaining open during regular business hours and continuing to provide access to all staff.
• Inquiring of all staff, subjects and visitors questions recommended by CDC regarding signs and symptoms, international travel, and contact with at risk individuals.
• Asking all patients if they have symptoms of COVID-19 on appointment reminder call and reschedule visits if subject endorses any symptoms. PCP clearance required to reschedule visits.
• Conducting remote study visits when possible as allowable per sponsor approval.
• Obtaining daily body temperatures from all staff, subjects and visitors prior to entry into any site locations. Any individual with a reading 100.4°F or above is immediately instructed to return home and will only be admitted with PCP clearance.
• Posting informative signs from CDC throughout all facilities.
• All prescreens conducted via telephone only and patient visits are staggered to reduce number of subjects in clinic at one time. Limited congregation of any individuals to ten with removal of chairs from waiting rooms to ensure patients are seated at least six feet apart.
• Work with sponsors to ensure delivery of study meds directly to patients unable to attend clinic visits.
• Limiting on-site monitoring and development and implementation of remote monitoring Work Instruction.
• Continuously assess site staff telecommute options to minimize exposure and reduce onsite hours as feasible per position. Minimize inter-office traffic, use the phone instead of in-person interactions. Company meetings conducted via teleconference to limit exposure. Expedite patient visits and stagger number of patients in clinic at one time. Limited congregation of any individuals to 10 and ensuring patients are at least six feet apart. Weekly teleconferences to keep staff updated on changes to CDC guidelines or company procedures for safety.
• Development or revision of SOPs or Work Instructions in accordance with FDA Guidelines released on 18/Mar/2020.
• Weekly staff teleconferences or email communication to keep staff informed of current pandemic status and CDC recommendation updates, as applicable.
• Communicating with sponsors, CROs and other sites about ways to continue serving subjects in a safe way to keep our industry moving forward.