On-Demand Webinar

Learn how to create CDISC domains in minutes with PK Submit

Creating CDISC domains as part of the pharmacokinetic (PK) deliverable for regulatory submissions can be…

CertaraMarch 1, 2023

White Paper

Understanding Europe’s New Clinical Trial Regulations (EU-CTR)

While the new EU-CTR will help to streamline clinical trials, which will benefit both patients…

CertaraFebruary 27, 2023

Blog

Common Clinical Trial Disclosure Challenges & Potential Solutions

Pharmaceutical companies are being required to be more transparent through the timely disclosure of more…

CertaraFebruary 24, 2023

On-Demand Webinar

FDA Modernization Act 2.0 – What does it mean for drug developers?

Historically, the FDA has required drug discovery and development programs to include animal testing. This…

CertaraFebruary 21, 2023

On-Demand Webinar

RAPS Sponsored: How Drug Developers Can Navigate the Inflation Reduction Act

The Inflation Reduction Act (enacted in August 2022) contains profound changes for the healthcare and…

CertaraFebruary 10, 2023

On-Demand Webinar

Data Visualization with SEND Data to See What Happened at the Preclinical Phase

SEND is an implementation of CDISC’s (Clinical Data Interchange Standards Consortium) SDTM (Study Data Tabulation…

CertaraFebruary 9, 2023

White Paper

A Guide to the UK Regulation of Medicines and Medical Devices Post-Brexit

CertaraFebruary 8, 2023

Podcast

Podcast interview with Dr. Elvira Müller. EU joint HTA – decided, but how will it be executed and how should companies prepare

In Europe, there are at least as many reimbursement assessment processes in place as European…

CertaraFebruary 7, 2023

Announcement

FDA awards new grants to support developing & assessing complex generic drugs

Certara’s Simcyp physiologically-based pharmacokinetic (PBPK) Simulator is being used to verify and expand biosimulation models…

CertaraFebruary 7, 2023

Blog

Artificial Intelligence: What is it & how can it accelerate rare disease drug development?

Large & complex information streams present opportunities for the AI data scientist to aid in…

CertaraFebruary 3, 2023

pre-update

Learn how to create CDISC domains in minutes with PK Submit

Understanding Europe’s New Clinical Trial Regulations (EU-CTR)

Common Clinical Trial Disclosure Challenges & Potential Solutions

FDA Modernization Act 2.0 – What does it mean for drug developers?

RAPS Sponsored: How Drug Developers Can Navigate the Inflation Reduction Act

Data Visualization with SEND Data to See What Happened at the Preclinical Phase

A Guide to the UK Regulation of Medicines and Medical Devices Post-Brexit

Podcast interview with Dr. Elvira Müller. EU joint HTA – decided, but how will it be executed and how should companies prepare

FDA awards new grants to support developing & assessing complex generic drugs

Artificial Intelligence: What is it & how can it accelerate rare disease drug development?

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