Certara.com

Certara Accelerating Medicines with Biosimulation and Tech …

WEBUnmatched Experience and Expertise. Our drug-development consultation services reflect decades of experience from more than 650 healthcare and pharmaceutical …

Actived: 4 days ago

URL: https://www.certara.com/

Health Economics Outcomes Research Certara

WEBHealth Economics Outcomes Research (HEOR) As our flagship and foundational business, our health economics and outcomes research consultants support the assessment and …

Category: Health Go Health

Certara Announces the Formation of a New Practice Area Focused …

WEBPDF Version. PRINCETON, NJ – July 9, 2019 – Certara®, the global leader in model-informed drug development, regulatory science, real-world evidence and market …

Category: Health Go Health

Certara Services Best practices in new drug development

WEBCarl de Moor, PhD Senior Vice President for Biometrics and Data Sciences. Carl received his Ph.D. in Biostatistics from the University of Washington. He was faculty at UT MD …

Category: Health Go Health

Regulatory submissions and transactions with Health Canada

WEBStarting January 1, 2020, all regulatory transactions for Master Files prepared in the non-eCTD format must be sent via the Common Electronic Submission …

Category: Health Go Health

Certara Acquires Analytica Laser, a Leader in Market Access, Health

WEBAnalytica Laser is a global leader in population health intelligence. It is committed to providing the highest level of scientific evidence of real-world value of …

Category: Health Go Health

Health Outcomes Performance Estimator (HOPE) Certara

WEBBest-in-class for predictive modeling. Built on best-in-class modelling, mathematics, simulation and Bayesian statistics, Certara’s Health Outcomes Performance Estimator …

Category: Health Go Health

Trends for Market Access, HEOR, and Real World Evidence

WEBHealth technologies are leveraged to tackle the problem of medication non-adherence. Medication non-adherence has been estimated to cost the US healthcare system …

Category: Health Go Health

Planning a Health Canada PRCI Compliant Submission Certara

WEBHealth Canada’s timeline for publishing clinical submission documents is 120 days from the regulatory decision. While this may appear to be ample time, some factors …

Category: Health Go Health

Key Trends in US Specialty Pharmacy

WEBper health plan type are reported to illustrate and provide a deeper understanding of the research findings. The numbers of reported lives are approximations provided by …

Category: Health Go Health

Certara Regulatory Science Up to date & advance technology

WEBCertara Regulatory Services. Your trusted partner to get it right the first time. Preparing a regulatory submission for global regulatory approval requires significant expertise, effort, …

Category: Health Go Health

Regulatory Science Regulatory technology as a solution

WEBOur regulatory solutions help you review a submission’s data quality, CDISC compliance, and fitness for use, in one cloud platform – the same platform used by the FDA and …

Category: Fitness Go Health

European Collaboration on Health Technology Assessment …

WEBHealth Technology Assessment (HTA) has long played a pivotal role in shaping healthcare systems worldwide. HTA examines the implications and applications of health …

Category: Health Go Health

Mind the Gap: Best Practices in Clinical Pharmacology Gap

WEBThe first step in a strategic assessment is a gap analysis. In conducting a program gap analysis, we consider the 40 different questions that the agency will ask …

Category: Health Go Health

Certara Market Access and Pricing Establishing proper value

WEBEstablish value of your health care innovation. An exponential rate of innovation, increased competition, and the growth of cost containment pressures create a greater need to …

Category: Health Go Health

Health Canada PRCI Guiding Principles and Observations

WEBHealth Canada released guidance on March 12, 2019 pertaining to its Public Release of Clinical Information (PRCI) initiative. Health Canada’s objective with …

Category: Health Go Health

Certara Acquires Analytica Laser, a Leader in Market Access, Health

WEBAnalytica Laser is a global leader in population health intelligence. It is committed to providing the highest level of scientific evidence of real-world value of …

Category: Health Go Health

Health Canada Regulatory Modernization: Yesterday, Today …

WEBIn 2017, Health Canada started a five-year initiative on improving regulatory review of drugs and devices (R2D2)1. The goal of this initiative was to develop an agile regulatory …

Category: Health Go Health

Certara Real World Evidence (RWE) Offering real world data …

WEBReal world evidence (RWE) has become important for regulatory decision-making as well, touching all areas of the healthcare value chain. Historically, RWE was used for post …

Category: Health Go Health

Certara Advances Global Initiative to Take Model-Informed …

WEBCertara has recently published four peer-reviewed MIPD papers; its progress is generating strong interest from industry, health care professionals and regulators. …

Category: Health Go Health

Early HTA Engagement Certara

WEBElvira is an expert in HTA engagements with substantial experience in health technology assessment, reimbursement strategy and early dialogues, both national and multi-HTA …

Category: Health Go Health

Anonymization vs. Redaction of Clinical Trial Data Certara

WEBAnonymization is the process of removing values for variables which allow direct or indirect identification of a clinical trial volunteer from the data. “Anonymization” …

Category: Health Go Health

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