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
Leveraged since 2005, 6,000+ FDA reviewers are now using GlobalSubmit technology
Health Canada released guidance on 2019年3月12日 pertaining to its Public Release of Clinical Information (PRCI) initiative. Health Canada’s objective with this initiative is to make anonymized clinical information in drug submissions and medical device applications publicly available for non-commercial purposes to enable re-analyses of data, foster new research questions, and help Canadians to … Continued
Model-based meta-analysis (MBMA) helps sponsors to make the wisest, most informed decisions about the next steps in their drug’s development and market positioning.
Aligned with newly issued FDA Draft Guidance, Phoenix supports electronic data, methods and results audit, traceability and communication requirements.