Certara

Certara Announces First Enrollee in International Registry to Assess Preventative Therapies in Healthcare Workers Exposed to COVID-19

Retrieved on: 
木曜日, 8月 13, 2020

Certara, the global leader in biosimulation, has launched an international registry of healthcare workers to collect information on risk factors for developing COVID-19 and the use of preventative therapies.

Key Points: 
  • Certara, the global leader in biosimulation, has launched an international registry of healthcare workers to collect information on risk factors for developing COVID-19 and the use of preventative therapies.
  • The International Registry of Healthcare Workers Exposed to COVID-19 (UNITY Global) will enable prevention policies to be informed by real-world data collected from 10,000 healthcare workers in low- and middle- income countries.
  • Healthcare workers on the frontlines of the COVID-19 outbreak response are at high risk of exposure due to the nature of their work.
  • As the extent of this outbreak is changing daily, guidance and policies for protecting healthcare workers need to rapidly evolve.

Certara and DMTC Ltd Announce Research Collaboration to Study Preventative Use of Chloroquine in Health Care Workers at High Risk for COVID-19

Retrieved on: 
木曜日, 5月 7, 2020

Certara will support the DMTC-led clinical trial by analyzing study data to develop mathematical models to understand the viral time course and factors impacting drug exposure and prophylactic response in health care workers.

Key Points: 
  • Certara will support the DMTC-led clinical trial by analyzing study data to develop mathematical models to understand the viral time course and factors impacting drug exposure and prophylactic response in health care workers.
  • With no approved treatments for COVID-19, researchers across the globe are rapidly searching for safe and effective treatments for the disease.
  • DMTCs Chloroquine Chemoprophylaxis Countermeasure Against COVID-19 (C4) Study is a randomized, controlled study of healthy, adult healthcare workers drawn from military and civilian workforces, at risk of SARS-CoV-2 infection.
  • Certara will analyze the data to conduct exposure-response research and build mathematical models to evaluate the relationship between chloroquine exposure and study endpoints.

Certara Partners with Galderma in Advancing Modeling and Simulation Technology to Attain FDA Approval of AKLIEF® Topical Acne Cream

Retrieved on: 
水曜日, 1月 8, 2020

Trifarotene is the first new retinoid molecule to receive FDA approval to treat acne in more than 20 years.

Key Points: 
  • Trifarotene is the first new retinoid molecule to receive FDA approval to treat acne in more than 20 years.
  • We are proud to support Galdermas successful NDA for AKLIEF (trifarotene) Cream, 0.005%.
  • It is important for patients, particularly pediatric patients, to have effective new options available to treat their acne, said Certaras Simcyp President and Managing Director Rob Aspbury, PhD.
  • It enables researchers to estimate local and systemic exposure resulting from either topical or transdermal absorption of different drug doses.

Certara Introduces Its Hasharc Decentralized Application for Healthcare at the Launch of Hedera Hashgraph Open Access

Retrieved on: 
火曜日, 9月 17, 2019

Certara, the global model-informed drug development and decision support leader, today announced the launch of Hasharc , its decentralized application (DApp) for healthcare, built in conjunction with the Hedera public Distributed Ledger Technology (DLT).

Key Points: 
  • Certara, the global model-informed drug development and decision support leader, today announced the launch of Hasharc , its decentralized application (DApp) for healthcare, built in conjunction with the Hedera public Distributed Ledger Technology (DLT).
  • The release of Hasharc coincided with Hederas own major milestone release of Open Access for the mainnet network and the introduction of the mirrornet.
  • Hasharc leverages both the mainnet and the mirrornet and builds on other key technological advances of the Hedera platform as well.
  • The Hedera Hashgraph platform offers a distributed public ledger with highly diversified governance that enables anyone to easily develop globally decentralized applications.

Certara Introduces Integral, its Next-generation Data Repository

Retrieved on: 
火曜日, 5月 28, 2019

Certara the global leader in model-informed drug development, regulatory science, real-world evidence and market access services, today announced the introduction of Certara Integral, its next-generation data repository for collecting, managing, and storing multiple types of data sets for analysis, sharing and reporting of clinical pharmacology, pharmacometrics and other relevant clinical data.

Key Points: 
  • Certara the global leader in model-informed drug development, regulatory science, real-world evidence and market access services, today announced the introduction of Certara Integral, its next-generation data repository for collecting, managing, and storing multiple types of data sets for analysis, sharing and reporting of clinical pharmacology, pharmacometrics and other relevant clinical data.
  • Certara Integral combines the attributes of a software-agnostic data warehouse with a workflow-driven tracking and retrieval toolkit housed in a cloud-based, 21 CFR Part 11 compliant infrastructure.
  • Certara Integral is agnostic with respect to the type of analytical tool or data used by the customer.
  • Certara will be hosting a one-hour webinar entitled Next-generation Data Repository for Clinical Pharmacology & Pharmacometrics to introduce Certara Integral and cover its most important attributes on May 29 at 11 am EDT.