Accelerate Your Clinical Data: Expert Tips from Protocol to Submission
At Certara, our goal is to dramatically increase R&D productivity by reducing new drug failure rates. We help maximize resources and accelerate the development of safe and effective treatments through a model-informed drug development approach, combined with data analytics, and scientific and regulatory expertise. ?
In this month's newsletter, you’ll see how the Pinnacle 21 Clinical Data Management and Automation Suite helps sponsors and CROs increase the speed and quality of clinical trial submissions. Go from protocol to submission in half the time with standards management, EDC (Electronic Data Capture) build, external vendor data reconciliation, and generation of SDTM and define.xml!
Contact us to learn how we can help create efficiencies in your clinical trials, from design to submission.?
?BLOG: Everything You Need to Know About SDTM?
This blog explores the basics of the Study Data Tabulation Model (SDTM), one of the most important CDISC data standards. Find out why SDTM is so important, and how to organize and present clinical trial data in accordance with this standard. ?
ON-DEMAND WEBINAR: Higher Standards: Achieving Cleaner Data, Faster, from Protocol to Submission
Join us to learn best practices for leveraging data standards to improve study content design, trial management transparency, and automate data capture and third-party transfer. ?
VOICE OF THE CUSTOMER: Chinese CRO, Zhejiang Longcharm Biomedical Technology
Hear directly from one of our customers about how they use our Pinnacle 21 Enterprise platform to optimize sponsors’ non-clinical and clinical regulatory review processes - saving time and improving communication between stakeholders.? ?
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SOFTWARE: Pinnacle 21 Clinical Data Management and Automation Suite
Find out how you’re better off with Pinnacle 21, the next generation cloud suite that optimizes the end-to-end clinical trials process for increased efficiency, maximum data quality, and improved data flow.? ??
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About Certara
Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries.
Corporate Headquarters: 100 Overlook Center, Suite 101, Princeton, NJ 08540 USA