Clinical Ink Implements COVID-19 Therapy Trial

Clinical Ink has helped expedite the study of a treatment for cytokine storm, the immunological reaction associated with severe cases of COVID-19. Clinical Ink purpose-built and deployed the electronic study environment in 15 business days, including the study’s full schedule of assessments, a full complement of edit checks and logic, and complete user acceptance testing.

“When you want to receive and analyze data quickly, being able to condense build times to meet urgent deadlines makes all the difference,” said Clinical Ink CEO Ed Seguine. “Furthermore, our eSource platform allows overtaxed caregivers to streamline data entry. Data is visible for remote monitoring in real time — of particular importance when sites are inaccessible and a vital consideration for this disease condition, which can change rapidly and dramatically.”

The flexibility of the Lumenis™ technology platform and its ability to be adapted and deployed quickly have minimized the timeline for this 300-patient, 36-site study.

“Clinical Ink’s data handling makes investigative teams’ processes very efficient,” said Chief Business Officer Jonathan Andrus. “They enter data only once and stay focused on treating patients. And for sponsors, having validated data immediately available for real-time decision making is reassuring, especially in a study of critically ill patients.”

The drug under investigation is a novel intravenous anti-inflammatory. This new molecular entity is a granulocyte macrophage colony stimulating factor antagonist that already has Phase I safety data from a clinical trial in volunteers and patients with ankylosing spondylitis.