Press Release

Press Release

Clinical Ink Study Assurance Program Waives Millions of Dollars in Change Order Fees for Ongoing Clinical Trials

April 29, 2020

Horsham, Pa.; April 29, 2020 – Clinical Ink, a global clinical trial technology company, has announced a wide-ranging Study Assurance Program to minimize financial impact of the disruption from COVID-19 on new and existing clinical trials. The effect of global quarantines has dramatically impacted new patient recruitment and has substantially changed how existing patients participate in ongoing clinical trials.

Starting the week of March 15, Clinical Ink’s overall system usage showed a steep decline in new patient enrollment and a modest but steady decline in existing patient activity. Notably, the last two weeks have shown a stabilization in existing patient activity at about 65% of the levels seen in February and new patient activity has rebounded slightly to about 20% of prior levels. Site activity (measured by unique and total user logins) has also been constant over the last month at about 70% of prior activity levels, indicating sites are doing their best to maintain patient data and respond to remote monitoring requests even while working from home.

“This is a time to show that patients actually matter — it’s not just about money,” said Clinical Ink CEO Ed Seguine. “Clinical Ink is putting patients first by proactively waiving potentially millions of dollars in change orders so that new and current studies can continue without our customers having costs increase both now and in the long run. Beyond the financial implications, we are changing how we approach our service delivery — including deploying a new direct data capture (DDC) study in just 15 days for a novel COVID-19 treatment option. All of us feel a heightened sense of uncertainty right now, but we view this as a compelling moment to show our commitment to customers and patients in a meaningful way. I invite other clinical technology and service providers to make a similar pledge so that our combined efforts can help ensure patients truly do come first.”

In anticipation of the likelihood that current studies will be delayed, Clinical Ink’s Study Assurance Program includes contracting adjustments for all current and new studies:

  1. Change order waiver of all platform licensing and help desk fees for a period of up to three months for all current and new studies.
  2. Project management fees specifically related to implementing bring your own device (BYOD) ePRO deployment will be waived (e.g., IRB approvals, scale license provisioning, device management plans).
  3. Help desk services to assist patients struggling with “virtual visit” technologies will be offered at no additional charge for the duration of the study.
  4. Logistics options have been expanded to include provisioning phones, tablets, and internet connectivity directly to patients in need.

“Our customers rely on our experience, capabilities, and technology to ensure the science behind their study protocol is reflected in the patient data itself,” said Clinical Ink Chief Business Officer Jonathan Andrus. “The business of drug development is expensive and uncertain — plans frequently change. Fortunately, Clinical Ink’s technology platform offers the broadest range of capabilities for clinical trials to succeed in a post-COVID-19 world. We want to succeed commercially based on our platform capabilities, not on change orders. The Clinical Ink Study Assurance Program is our way of sharing the responsibility we all have to work together in a new normal.”

To learn more about Clinical Ink’s decentralized trial offerings including DDC, eCOA, ePRO, eConsent, and other capabilities, download our fact sheet.

About Clinical Ink

Clinical Ink, a global clinical technology company, offers data certainty from source to submission. Our Lumenis™ eSource clinical technology and configurable direct data capture, eCOA, ePRO, and eConsent modules — a suite of solutions for capturing and integrating electronic data from sites, clinicians, and patients at its source — naturally enhance your clinical trial workflow by reducing manual labor, providing anytime, anywhere data access, and saving resources as your trials progress. Visit clinicalink.com.