NEW YORK, Oct. 26 (Korea Bizwire) – Informa Pharma Intelligence, the global business intelligence provider for the biopharma industry, has launched TrialScope Atlas, a single, searchable dashboard that automates clinical trial disclosure and consolidates a concise set of relevant regulations.
Clinical trial sponsors are under increased pressure to maintain regulatory disclosure compliance, for several reasons:
- The EU CTIS clinical trial disclosure portal is scheduled to launch in January, bringing with it new regulations for study registration.
- Failure to disclose required information to ClinicalTrials.gov, under the auspices of the US National Institutes of Health, can result in fines of over $12,000 per trial per day.
- Lack of transparency leads to public mistrust and negative brand reputation.
- Potential investors are likely to walk away from deals involving noncompliant companies.
However, no global standards exist for the scope and timing of disparate global disclosure requirements. With dozens of regulatory agencies worldwide and hundreds of disclosure regulations, sponsors are faced with the insurmountable challenge of keeping on top of changing regulatory requirements. In addition, global regulatory teams are often disjointed, separated by geography and time zones.
TrialScope Atlas offers a centralized dashboard, uniting regulations as well as users. A robust compliance engine, backed by years of TrialScope’s industry-leading disclosure experience, powers the platform. Disclosure experts monitor and analyze global disclosure regulations, removing the burden from sponsors. When users enter their study data into the platform, they receive automated notifications of what information needs to be disclosed, when it needs to be disclosed, and to which registries.
“Global clinical trial disclosure compliance is at a key turning point,” said Denise Peterson, Editor-in-Chief of Pink Sheet, the Informa Pharma Intelligence publication providing regulatory and policy insights. “The US FDA has recently sent warning notifications to clinical trial sponsors, who could face fines over $12,000 per day for disclosure noncompliance. And in January 2022, the EU will be launching its new trials portal and Clinical Trials Regulations, which is expected to kick off compliance inspections in EU member countries. Now, more than ever, study sponsors must take disclosure compliance seriously.”
About Informa Pharma Intelligence
Informa Pharma Intelligence powers a full suite of analysis products – Datamonitor Healthcare™, Sitetrove™, Trialtrove™, Pharmaprojects™, Biomedtracker™, Scrip™, Pink Sheet™ and In Vivo™ – to deliver the data needed by the pharmaceutical and biomedical industry to make decisions and create real-world opportunities for growth.
With more than 400 analysts keeping their fingers on the pulse of the industry, no key disease, clinical trial, drug approval or R&D project isn’t covered through the breadth and depth of data available to customers. For more information, visit pharmaintelligence.informa.com
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Source: Informa Business Intelligence via GLOBE NEWSWIRE