Covid-19 Sponsors/CROs

During the COVID-19 crisis, MedPharmics is firmly committed to continuing our services to the pharmaceutical industry. Specifically, this means that site staff are available to complete outstanding study items and/or communicate with CROs and sponsors. There is no time more relevant than our current situation for MedPharmics to continue to support clinical trials for tests, vaccines, and medications. Without clinical research, it would not be possible to develop new vaccines and treatments for diseases like COVID-19.

To date, no staff member at any site is exhibiting symptoms of infection. Furthermore, MedPharmics is not restricting CRA access to any of our facilities. If CROs prefer remote monitoring, we can also accommodate those requests. All sponsors and CROs will be immediately notified of any change in our status.

All of the following policies and procedures are subject to change, based upon recommendations from the World Health Organization (WHO) and the Centers for Disease Control (CDC). Our goal, as always, is subject and staff protection and data integrity. Our intention is to adhere to protocol requirements as closely as possible. If necessary, alternative visits, as outlined below, will be implemented.

• All subjects during visits and during routine phone calls are questioned regarding fever (in excess of 100.4), cough, shortness of breath, and foreign travel. If anyone (subject or caregiver) comes to the site with symptoms of fever greater than 100.4 and cough or shortness of breath, staff will put on an N-95 mask and then provide the individual with an ear-loop mask. CRCs will then follow updated safety procedures to complete the visit.
• If positive surveillance information is obtained during a phone call and the subject is scheduled for a critical, upcoming visit (i.e. a visit requiring the obtaining of a specimen – either blood or a nasopharyngeal swab), we have established procedures to conduct the visit in the subject’s vehicle in our site’s parking area. If the upcoming visit does not involve obtaining any specimen, the visit will be conducted by phone.
• All magazines have been removed and pens are now single use.
• Patients will be staggered so people are not waiting in groups, and taken to their exam room immediately.
• Entering and exiting patients will use separate entrances.
• No home visits will be performed on any subjects diagnosed with COVID-19. MedPharmics has developed procedures for remote and home visits and will perform these as needed for critical data collection.

• Staff wash their hands with soap and water for at least 20 seconds after every subject interaction. When soap and running water are unavailable, alcohol-based hand rub with at least 60% alcohol is available.
• Touching of the eyes, nose, or mouth is avoided.
• Good respiratory hygiene is enforced. This means covering the mouth and nose with a bent elbow or, preferentially, with tissue when you cough or sneeze.
• After each subject visit, all surfaces touched by human hands – equipment (BP machines, scales, etc.), doorknobs, counters, exam tables, chairs, toilet seats, etc.- are wiped down with an approved disinfectant.
• In addition to the above, MedPharmics is now encouraging social distancing (approximately six feet between individuals; no hand shaking or hugging).
• Staff are instructed to self-isolate at home if they develop fever greater than 100.4 and a cough.

MedPharmics can conduct visits by phone or online. We will continue to collect data as usual and proceed with scheduled calls. Patients can request a remote visit, if data collection is not required.

MedPharmics has developed procedures for home visits and will perform these as needed for critical data collection. No home visits will be performed on any subjects diagnosed with COVID-19.

In the event of hospital lock downs, we will abide by all local, state, and federal requirements, though it is likely entry to the hospital will be severely restricted. Any individual in a study that requires swabbing for mild to moderate viral respiratory symptoms should be instructed to come to the research site to be swabbed. If the subject is admitted to the hospital, then hospital records will be obtained after discharge. If any subject first goes to the hospital without first notifying the site and is subsequently sent home, that individual should be swabbed either at home or at the research site at the earliest opportunity.

Other collection requirements, such as cord blood, will be done by our PIs and given to MedPharmics staff at a designated area of the hospital.

If a quarantine order is issued for the area, the only change that would occur involves any subjects residing outside of the quarantined zone. In that situation, neither site visits nor home visits would be conducted. All visits would be completed by phone.