JERSEY CITY, N.J., Feb. 11, 2016 /PRNewswire/ -- TrialScope, the global leader in clinical trial transparency and compliance solutions, today announced that it will host a live, complimentary webinar titled, "Are You Ready for the Changes Coming with NPRM and the EU Portal?" on Thursday, February 25, 2016 at 11:00 am eastern.
The Notice of Proposed Rulemaking (NPRM) in the U.S. and the European Clinical Trial Regulation in the EU promise to put additional time pressures on clinical trial disclosure teams. Join TrialScope's Chief Strategy Officer, Thomas Wicks and Senior Product Specialist, Matt DeFranco, for a timely discussion of how life sciences teams can prepare for these changing requirements. The new regulations will mandate significantly reduced reporting timelines, demand operational efficiencies and will require changes to existing procedures and standard operating procedure documentation.
Mike Forgash, Chief Executive Officer, noted, "The upcoming changes promise to add complexity to an already difficult set of compliance requirements. We think it is important to help clinical trial sponsors understand the impact and begin to plan now to meet these increasingly rigorous obligations."
"Reduced reporting timelines will be an additional burden on disclosure teams," Thomas Wicks, Chief Strategy Officer, added. "Some timelines will be reduced by as much as 50% in the U.S. and 83% in the EU. We hope to minimize this burden and mitigate the compliance risk for sponsors with some recommendations and best practices that will prepare their teams and optimize their supporting processes."
TrialScope simplifies the complexities of clinical trial transparency performance. TrialScope's proven solutions have been implemented successfully and rigorously tested in the most complex environments and are managing disclosures for roughly 30% of industry sponsored clinical trials. The company's market-driven solutions and expertise enable sponsors to improve performance, mitigate compliance risk, and ultimately optimize efficiencies with clinical content lifecycle management tools, expertise and processes. TrialScope technologies are offered via a validation-ready SaaS platform hosted in a private cloud.