Tag: Synchrogenix
Regulatory Operations
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Safety and Pharmacovigilance
Scientific and Medical Communications
Considerations for Managing Clinical Trials and Regulatory Filing Strategy During COVID-19
Regulatory Agencies across the world have quickly responded to the COVID-19 pandemic. Your approach to ongoing and new clinical trials and regulatory filing during COVID-19 requires adaptation and new strategies, such as following recommendations and using the fast-track COVID-19 programs recently instituted by Regulatory Agencies. In this white paper, we will focus on the reactions … Continued
PharmaTimes: Interview with Demetrius Carter, The Future is Diversity Issue
Certara’s Synchrogenix Artificial Intelligence Technology
Patient Engagement and Patient Centricity Series Part II: Types of Patient Advocates
Nirpal Virdee, Synchrogenix’s Global Head of Transparency and Disclosure recently sat down with Trishna Bharadia, award-winning health advocate and patient engagement champion, for a discussion around patient engagement and patient centricity. Their discussion was moderated by Darshan Kulkarni of the podcast ‘Darshan Talks’ for a series of episodes that you can listen to here. Darshan … Continued
FDA Renews Licenses for Synchrogenix’s GlobalSubmit Software to Review and Validate New Drug and Biologics Applications
Leveraged since 2005, 6,000+ FDA reviewers are now using GlobalSubmit technology