TrialScope: customers concerned about mitigating non-compliance risks

According to the clinical trial transparency and compliance solutions company, all four customers have contracted the company’s SaaS-based clinical trial disclosure platform, PharmaCM.

“PharmaCM provides a single source for clinical trial disclosure data and processes. This helps sponsors ensure that disclosed content is aligned regardless of the registry being used around the world​,” Thomas Wicks, COO of TrialScope, told Outsourcing-Pharma.com.

With impending regulations (NPRM​ in US and EU Clinical Trial Regulation in EU) clinical trial sponsors will be required to report additional trial data in shorter time frames.

“This adds complexity under tighter deadlines and puts a great emphasis on having good trial disclosure capabilities and repeatable and consistent processes​,” explained Wicks. 

As Outsourcing-Pharma.com previously reported​, NPRM, the Notice of Proposed Rulemaking for the "Common Rule," was announced by the Department of Health and Human Services and fifteen other Federal Departments and Agencies in September 2015. The NPRM proposes revision to the regulations for protecting human subjects in research.

However, a study committee recently suggested that the executive brand withdraw NPRM – other suggestions have been detailed in a report​ to Congress.

Regardless, regulations are looming, and Wicks said customers are concerned about mitigating the risks of non-compliance and are working to improve operational efficiencies.

As part of its offering, TrialScope is also employing its Rapid Path to Compliance engagement methodology, which shares best practices and lesson learned.

Based on the current state of the industry, Wicks explained, “We see clinical trial transparency continuing to increase in complexity as more registries evolve and new requirements for additional data emerge​.”