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Systematic literature review of cross-protective effect of HPV vaccines based on data from randomized clinical trials and real-world evidence Publication

The extent of cross-protection provided by currently licensed bivalent and quadrivalent HPV vaccines versus direct protection against HPV 31-, 33-, 45-, 52-, and 58-related disease is debated. A systematic literature review was conducted to establish the duration (...)

Purity is a Virtue: A Practical Guide to the Reporting of Impurities On-Demand Webinar

Many pharmaceutical companies struggle with characterizing drug substance (DS) and drug product (DP) impurities and how to include them in their regulatory applications. This webinar is designed to increase the understanding of the regulatory guidances (e.g., ICH, FDA, and EMA)...

Document Quality and Management Page

Certara’s regulatory document quality and management services help sponsors ensure accuracy, compliance, and efficiency in their regulatory submissions.

Leveraging a Compliant Data Repository to Significantly Improve Biostatistics Workflow Brochure

Strategic Evidence & Value Communication Symposium On-Demand Webinar

Join us on Wednesday, April 21, 2021, from12:00 PM – 2:00 PM EDT for Certara's first annual Strategic Evidence & Value Communication Symposium. Across two panel discussions, a host of Certara and industry experts will debate and explore various best practices to ensure effective communication of product value, as well as the expanded use of Real World Evidence to accelerate market access decision-making.

Legislators: Bring all stakeholders to the table to lower drug costs Press Coverage

BY ROMAN CASCIANO, OPINION CONTRIBUTOR — 03/29/21 05:30 PM EDT No one is happy with the price of drugs nor how we pay for them: not patients, not the lawmakers who represent them, not physicians, not insurance payers and not drug...

Predicting the Effect of the Dulaglutide-Mediated Gastric Emptying Delay on Drug Exposure On-Demand Webinar

The European Medicines Agency (EMA) recently approved dulaglutide (Trulicity®) at higher doses (3 mg and 4 mg solutions). Dulaglutide is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise. ...

Getting started with in-house development: how does it work? Blog Post

Learn how in-house app development with BaseCase enables rapid creation, centralized management, and unmatched flexibility to communicate product value.

Getting started with in-house development: storyboarding Blog Post

Learn key storyboarding best practices to optimize your in-house mobile app development & effectively communicate product value.

Economic and Clinical Burden of Virus-Associated Hemorrhagic Cystitis in Patients Following Allogeneic Hematopoietic Stem Cell Transplantation in the United States Publication

Authors: Joseph McGuirk, Clint Divine, Seung Hyun Moon, Aastha Chandak, Zhiji Zhang, Genovefa A. Papanicolaou Hemorrhagic cystitis (HC) caused by viral infections such as BK virus, cytomegalovirus, and/or adenovirus after allogeneic hematopoietic stem cell transplantation (allo-HCT) causes morbidity and mortality,...

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