Cluepoints is a software developer providing clinical trial monitoring services. It is in partnership with the US Food and Drug Administration with the objective to support the regulator’s oversight of the clinical trial market.
The spread of the coronavirus pandemic has caused significant hurdles in clinical research, with participants unable or not willing to visit the sites, employees needing to work remotely, and regulatory bodies cancelling scheduled inspections.
“In recent weeks we have seen the practice of working remotely transform from a ‘nice-to-have’ into an imperative for business continuity,” the company said, adding that, in clinical trials, the mounting restrictions on site visits means that sponsors and their CRO partners are actively seeking alternative, remote approaches to monitoring study conduct, compliance, patient safety and data quality across participating sites.
Amid these circumstances, Cluepoints suggests that it has ‘mobilized’ its services, aiming to support the clinical research industry that strives for business continuity and tries to eliminate delays of drug development projects.
According to the company, eliminating or reducing site visits can happen without significantly impacting trial oversight, with its clients having already implemented remote and centralized site monitoring.
Cluepoints suggests that its Central Monitoring Platform, which offers site follow-up by web, phone and email when risks are detected, is currently experiencing increasing demand.
Patrick Hughes, the company’s CCO, said that, although the industry has been moving towards central monitoring, “the current crisis is forcing more rapid change now.”
“We have an important opportunity to play our part in supporting all patients and stakeholders involved in clinical trials to ensure safety and integrity,” Hughes said, adding “We are all worried about the potential effect of COVID-19, on both a business and personal level, but there are simple, easy-to-deploy solutions that remove the need for on-site human intervention that can also help to ensure business continuity.”
