Blog

Gain nonclinical drug safety insights with real-time data analysis

February 24, 2025 Efficient drug development relies on informed decision-making. For toxicologists, having timely access…

CertaraFebruary 24, 2025

Blog

The history of Pinnacle 21

February 21, 2025 It was late 2007. Mad Men was the hottest show on TV.…

CertaraFebruary 21, 2025

Blog

How to validate your clinical data using FDA validation rules

January 30, 2025 For clinical data managers, understanding clinical data validation and applying FDA validation…

CertaraJanuary 30, 2025

On-Demand Webinar

GlobalSubmit eCTD 4.0 Webinars

The world of electronic regulatory submissions is about to change with the introduction of eCTD…

CertaraDecember 3, 2024

Poster

Population K-PD Modeling of Plozasiran (ARO-APOC3), a GalNAc-siRNA Conjugate, for the Treatment of Patients with Severe Hypertriglyceridemi

CertaraNovember 22, 2024

Poster

Population pharmacokinetic modeling of TBA-7371 in healthy participants describes apparent auto-induction of clearance and predicts PK in participants with Mycobacterium tuberculosis.

CertaraNovember 22, 2024

White Paper

Clinical Metadata Standardization: Evaluating the Importance of a Metadata Repository in Clinical Trials

Whether you’re considering a metadata repository or want to learn about clinical metadata standardization, our…

CertaraNovember 22, 2024

Poster

Building Automated Pharmacometrics Analysis Workflows in R with NMsim

CertaraNovember 22, 2024

Poster

Population K-PD Modeling of Plozasiran (ARO-APOC3), a GalNAc-siRNA Conjugate, for the Potential Treatment of Atherosclerotic Cardiovascular Disease (ASCVD) in Patients with Mixed Hyperlipidemia

CertaraNovember 22, 2024

Poster

Integrated Population Pharmacokinetic Model of Bemnifosbuvir and Metabolites

CertaraNovember 22, 2024

Data Standards

Gain nonclinical drug safety insights with real-time data analysis

The history of Pinnacle 21

How to validate your clinical data using FDA validation rules

GlobalSubmit eCTD 4.0 Webinars

Population K-PD Modeling of Plozasiran (ARO-APOC3), a GalNAc-siRNA Conjugate, for the Treatment of Patients with Severe Hypertriglyceridemi

Population pharmacokinetic modeling of TBA-7371 in healthy participants describes apparent auto-induction of clearance and predicts PK in participants with Mycobacterium tuberculosis.

Clinical Metadata Standardization: Evaluating the Importance of a Metadata Repository in Clinical Trials

Building Automated Pharmacometrics Analysis Workflows in R with NMsim

Population K-PD Modeling of Plozasiran (ARO-APOC3), a GalNAc-siRNA Conjugate, for the Potential Treatment of Atherosclerotic Cardiovascular Disease (ASCVD) in Patients with Mixed Hyperlipidemia

Integrated Population Pharmacokinetic Model of Bemnifosbuvir and Metabolites

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