A TrialAssure blog post starts with three words: planning, timing, and coordination to explain the formula that Sponsors should follow as the European Clinical Trials Regulation 536/2014 comes into full force in January 2022.
Author Karim Ibazatene, an Associate Director at MMS Holdings, writes that Pharma should focus on timelines to better capture the efficiencies that will come with the new regulations. To learn more, click here.
Thomas Wicks, Chief Strategy Officer at Trialscope, recently gave several presentations, including one on thinking and acting globally at the Informa Connect Clinical Data Disclosure, Transparency and Plain Language Summaries event A month prior, in April 2021, he penned an article on The Pink Sheet, offering key steps an organization needed to consider in order to master global clinical trial disclosure compliance.
Wicks wrote "...Clinical trial disclosure compliance must include identification and documentation of registry requirements, key stakeholders, company policies, systems, and processes. Many biopharma companies remain challenged to comply with mandatory government requirements for disclosing clinical trial information, whether due to lack of knowledge or lack of effective corporate policies and procedures. A strategy including documenting disclosure requirements and trials subject to disclosure, identifying internal stakeholders with compliance responsibilities, implementing policies explicitly endorsed by top management, and tapping into useful tech tools can help remedy the problem..."
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