JERSEY CITY, N.J., March 19, 2018 /PRNewswire/ -- TrialScope, the global leader in clinical trial transparency and compliance solutions, today announced that its Vice President of Global Transparency, Francine Lane, will host a live, complimentary webinar, "The Final Rule: Challenges & Best Practices," on Wednesday, March 21 at 11:00 a.m. ET.
The Final Rule, a required update to Title VIII of the Food and Drug Administration Amendments Act (FDAAA) of 2007, clarifies and completes requirements for registering clinical trials and disclosing clinical trial results to the FDA.
While the Rule went into effect in January 2017, results requirements only started a few weeks ago and there are still questions and confusion in the industry about what it all means. In this webinar, Lane will address some of the more complex provisions of the Final Rule and identify some of the common challenges in complying with the requirements.
"The Final Rule is not easy to understand," said Lane. "This webinar will provide insights gained while chairing the Drug Information Association's (DIA) Final Rule Working Group where I had the opportunity to discuss the many challenges and successes faced by organizations operationalizing the Final Rule requirements."
"At TrialScope, it's our mission to help organizations navigate these complexities efficiently and minimize risk," said Thomas Wicks, Chief Strategy Officer of TrialScope. "This new rule has already started to impact the industry and we are here to support clinical trial sponsors through this disclosure process."
To learn more, register for the webinar here.
About TrialScopeTrialScope simplifies the complexities of clinical trial transparency. TrialScope's award-winning, proven solutions have been implemented successfully and rigorously tested in the most complex environments and are managing disclosures for sponsors that are responsible for over 35 percent of industry sponsored clinical trials posted on clinicaltrials.gov. 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.
Contact: Alyson Kuritz 908-892-7149 [email protected]
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The Final Rule, a required update to Title VIII of the Food and Drug Administration Amendments Act (FDAAA) of 2007, clarifies and completes requirements for registering clinical trials and disclosing clinical trial results to the FDA.
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While the Rule went into effect in January 2017, results requirements only started a few weeks ago and there are still questions and confusion in the industry about what it all means. In this webinar, Lane will address some of the more complex provisions of the Final Rule and identify some of the common challenges in complying with the requirements.
"The Final Rule is not easy to understand," said Lane. "This webinar will provide insights gained while chairing the Drug Information Association's (DIA) Final Rule Working Group where I had the opportunity to discuss the many challenges and successes faced by organizations operationalizing the Final Rule requirements."
"At TrialScope, it's our mission to help organizations navigate these complexities efficiently and minimize risk," said Thomas Wicks, Chief Strategy Officer of TrialScope. "This new rule has already started to impact the industry and we are here to support clinical trial sponsors through this disclosure process."
To learn more, register for the webinar here.
About TrialScopeTrialScope simplifies the complexities of clinical trial transparency. TrialScope's award-winning, proven solutions have been implemented successfully and rigorously tested in the most complex environments and are managing disclosures for sponsors that are responsible for over 35 percent of industry sponsored clinical trials posted on clinicaltrials.gov. 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.
Contact: Alyson Kuritz 908-892-7149 [email protected]
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