A biopharmaceutical company was running a global 4-study program evaluating the long-term safety and effectiveness of a study drug in adult patients with a rare, inherited disease impacting the kidneys and other vital organs. The studies required urine collection, including 24-hour collections, blood draw, vital sign collection, and study drug administration via subcutaneous injection. The COVID-19 pandemic posed a threat to the program, with site closures and patient hesitancy to travel to sites. There was a significant risk that patients would miss crucial drug doses.

Accellacare In-Home Services (formerly Symphony Clinical Research) was contracted with the biopharmaceutical company to provide in-home study visits for the 2nd year of the program, but in-home visit were not yet active. Accellacare was able to work with the sponsor to immediately implement In-Home Services to bring drug administration and monitoring visits directly to patients, minimising their exposure to COVID-19. The initially contracted services were also expanded to include body system assessments, to meet the needs of the study.

In-Home Services worked with changing travel restrictions and lockdown requirements to implement in-home visits in as few as 3 days from the sponsor’s request to accelerate our services. The immediate response was possible because In-Home Services had already been contracted for the study, which meant that homecare had previously been included in the protocol and ICF and IRB/EC approvals. Due to the swift response, no doses were missed across all 4 studies.

In addition to the patient-centric benefits Accellacare In-Home Services always supplies, in this case, we were able to add a significant layer of protection for our client, allowing their 4-study program to continue without pause through a global pandemic. The same risk mitigation value can be added during other unforeseen events, like natural disasters, or even in cases of personal emergency which might take a patient away from their study site.

Testimonial

“It is a crazy time, but I’m grateful for the support from the team to allow patients to obtain study assessments and dosing at home to minimise their risk to COVID-19. Your team and the nurses are true heroes in all of this”

- Senior Director, Clinical Operations, 23 March, 2020