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:
“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.”
Merck Launches Phase III Trials of Once-Monthly Oral HIV PrEP Candidate MK-8527
July 14th 2025In the new EXPrESSIVE clinical trial program, Merck will evaluate MK-8527, a once-monthly, oral PrEP therapy, in populations at high risk of HIV-1 infection, including adolescent girls and women in sub-Saharan Africa.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Baxdrostat Shows Significant Blood Pressure Reduction in Phase III BaxHTN Trial
July 14th 2025In the BaxHTN Phase III study, AstraZeneca’s baxdrostat demonstrated statistically significant and clinically meaningful reductions in systolic blood pressure in patients with uncontrolled or treatment-resistant hypertension.
New FDA Initiative Reveals Common Reasons for Drug Application Rejection
July 11th 2025By publishing more than 200 complete response letters, the FDA is offering new visibility into the issues that most often delay drug approvals, including safety concerns, trial design flaws, and manufacturing gaps.
Arcus’ Quemliclustat Earns Orphan Drug Designation as Phase III Pancreatic Cancer Trial Advances
July 11th 2025The FDA has granted orphan status to Arcus Biosciences’ CD73 inhibitor quemliclustat for metastatic pancreatic cancer, as the global PRISM-1 Phase III trial nears full enrollment following promising survival data from ARC-8.