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ICT: What is clinical trial transparency?

TrialScope: Clinical trial transparency can mean different things to different people. In its broadest sense, it is to make a wide range of information about a clinical trial available to the public. This includes registering the trial at the time that it begins enrolling participants, disclosing summary results of the trial once it completes, sharing the more detailed study report and anonymised patient data, and providing a plain-language summary of the trial results. All of these components have legal or regulatory requirements, but organisations are pressured to share more than what is legally mandated.

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Thomas Wicks, Chief Strategy Officer at TrialScope, has more than 17 years of experience with performance and content management solutions, specialising in applications for life sciences such as clinical trial disclosure, structured product labelling, and submissions management. Thomas has been on the PharmaCM team since 2007. Prior to the acquisition of PharmaCM by TrialScope, he served as the General Manager of PharmaCM at Deloitte and as the Director of PharmaCM Product Management at Intrasphere Technologies. Before joining Intrasphere, Thomas worked in leadership, client-facing positions for Revelwood and Shepherd Systems, focussed on performance management solutions.

Francine Lane is the Vice President of Global Transparency at TrialScope. In this role, she is responsible for helping TrialScope customers meet and exceed current disclosure expectations globally, giving them the tools they need to meet all the requirements in this evolving industry. Francine also dedicates her time to building relationships with external stakeholders, including sponsors, investigators, regulators, and transparency and patient advocates, to help align the goals and expectations of these groups, as well as help identify more consistent ways sponsors can meet industry standards. Prior to her role as Vice President of Global Transparency, Francine served as Director of Product Management at TrialScope.
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News and Press Releases

Clinical and Regulatory Operational Excellence Forum

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Pre-Filled Syringes & Injectable Drug Devices Europe

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