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Certara USA, Inc.

Certara USA, Inc. is listed as a large business research supplier in the Scientist.com network, with 2 sites in 2 countries.

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Sites 2
Countries 2

Services

What this research supplier says it provides, as listed in the Scientist.com network.

Type of company: Large business

Chemistry, Manufacturing and Controls (CMC)

  • Chemistry, Manufacturing and Controls (CMC) Request Chemistry, Manufacturing and Controls services

Clinical Consulting

  • Bioanalysis Consulting Expert advice to properly and effectively discover, evaluate, and measure chemical or biological materials.
  • Biomarker Services Consulting Expert advice to conduct solutions for evaluating normal/abnormal biological conditions and characteristics within the body.
  • Biometrics Consulting Apply statistics and mathematics to drug discovery, clinical trials, and data analysis.
  • Biostatistics Consulting Apply statistical theory and mathematical principals to research
  • Clinical Consulting Provide high quality data, on time and within budget, while maintaining the flexibility in delivering personalized services.
  • Clinical Development Planning Complex document that entails the entire clinical research strategy of a drug, describing the clinical studies that will be carried out for a pharmaceutical entity.
Show all 14 in Clinical Consulting 8 more
  • Clinical Protocol Design & Development Creation of clinical protocol document which details how a clinical trial is designed, relating to to the methodology, hypothesis, and operation of clinical trial to ensure the safety of the patients is...
  • Clinical Study Reporting (CSR) Report results of clinical trials to regulatory agencies. This includes participant flow, baseline characteristics, outcome measures, statistical analyses, and adverse events.
  • Clinical Trial Consulting Consulting services for Clinical trials.
  • Clinical Trial Feasibility Request services related to Clinical Trial Design and feasibility.
  • IND Writing Consulting Consulting for an Investigational New Drug Application
  • Medical Science Liason (MSL) The primary purpose of the MSL role is to establish and maintain peer-peer relationships with leading physicians, referred to as Key Opinion Leaders (KOL’s), at major academic institutions and clinics.
  • Regulatory Compliance & Documentation Regulatory compliance describes the goal that organizations aspire to achieve in their efforts to ensure that they are aware of and take steps to comply with relevant laws, policies, and regulations.
  • Study Budgeting Consulting Request for Consulting Services

Clinical Trials

  • Bioequivalence Studies Assess the expected biological equivalence of two proprietary preparations of a drug.
  • Clinical Trial Design Develop study-related protocols, case report forms (CRFs) and database tools for records management.
  • Comparator Drug Sourcing Streamline new drug development and clinical trials by comparing the efficacy of an experimental drug to a comparator drug.
  • Pharmacokinetic Studies Design a study that observes the time course of drug absorption, distribution, metabolism, and excretion, as means to test the safety and effective therapeutic management of drugs in an individual patient.
  • Phase 1-3 Studies Design phase 1-3 studies that seek to identify if a drug is safe, effective, and more efficient than other available treatments on the market.
  • Regulatory Affairs Consulting Receive assistance ensuring compliance with regulatory requirements.
Show all 9 in Clinical Trials 3 more
  • Site Monitoring Maintain oversight over participant's health during a clinical trial.
  • Site Selection Select clinical trial sites with clinicians who recruit, enroll, treat and evaluate trial patients.
  • Study/Site Feasibility Study Explore and test study practicality.
Show all 82 services 69 more

Commercial Consulting

  • Portfolio Management Manage a portfolio of projects in early-stage drug discovery and provide factors that determine the success of the proposed portfolio.

Data Science/Bioinformatics

  • Discovery Statistical and Mathematical Modeling Use mathematical variables and equations to establish relationships between data.

Disease Models

  • Blood Models Test for therapeutic efficacy of drug candidates in blood disorder models.
  • Bone Models Measure therapeutic endpoints in animal models of bone disorders.
  • Cardiovascular Metabolics Models Measure therapeutic endpoints in animal models of cardiovascular disorders.
  • Cardiovascular Models Test the therapeutic efficacy of drug candidates in cardiovacular disease models.
  • Comparative Pharmacology Compare drug responses across species for improved reliability in translational studies.
  • Critical Care Models Diagnose and manage life-threatening conditions requiring sophisticated organ support and invasive monitoring.
Show all 14 in Disease Models 8 more
  • Dermatology Models Measure therapeutic endpoints in animal models of dermatological disorders.
  • In Vivo Technologies Models Carry out EEGs, cognition assessment, microdialysis, electrophysiology, MRI, ultrasound and tomographic analysis.
  • Infectious Disease Models Test therapeutic efficacy of drug candidate in infectious disease model.
  • Inflammation Models Measure therapeutic endpoints in animal models for inflammation.
  • Ophthalmic Models Test drug candidates in glaucoma, macular degeneration, keratitis, uveitis and CMV retinitis models.
  • Otology Models Measure vertigo, tinnitus, otitis media and hearing loss in animal models.
  • Pain Models Test therapeutic efficacy of drug candidate in pain model.
  • Respiratory Models Test therapeutic efficacy of drug candidate in respiratory disease model.

Drug Development

  • Assay Development Consulting Request consultant services measuring the activity of a drug or biochemical in an organism or organic sample.
  • Bioinformatics Consulting Consulting Services for the science of collecting and analyzing complex biological data
  • Chemistry, Manufacturing and Controls (CMC) Consulting Consultant services related to the development of pharmaceutical and biopharmaceutical drug products that are consistently effective, safe and high quality for consumers.
  • Consulting Services Work with consultants who provide expert advice in various areas of research and technology.
  • Large Molecule Drug Development Consulting Develop large molecule drugs and complex biologics that have a therapeutic effect.
  • Pharmacology Consulting Request consulting services related to pharmacology and the chemical properties, biological effects, and therapeutic uses of drugs.
Show all 9 in Drug Development 3 more
  • Safety Pharmacology Consulting Consulting services that help with the detection of potential undesirable pharmacodynamic effects of chemical entities on physiological functions.
  • Small Molecule Drug Development Consulting Request consulting services related to small molecule development.
  • Toxicology Consulting Use models to assess acute and sub-acute toxicity as well as chronic and sub-chronic toxicity.

General in vivo Toxicology

  • General Toxicology Use in vivo models to assess acute and sub-acute toxicity as well as chronic and sub-chronic toxicity.

In Vitro ADME

  • Drug Drug Interactions Determine whether a substance affects the activity of a drug when both are administered together.
  • HT ADME (High-Throughput Absorption, Distribution, Metabolism and Excretion) Analyze the process and effects of a chemical that is ingested by an organism using an advanced technological screening process. Use for drug...
  • Metabolic Stability in Hepatocytes Assess the susceptibility of drugs to metabolism by Phase I (CYP450) and Phase II enzymes in liver cells.

In Vitro Pharmacology

  • In Vitro Disease Models Screen pre-clinical candidates without the use of live animals.

In Vivo ADME

  • Absorption studies Study the factors determning how efficiently a compound may enter the bloodstream.

In Vivo Pharmacokinetics

  • In Vivo Pharmacokinetics Run pharmacokinetic studies in animals that measure a drug's absorption, distribution, metabolism and excretion (ADME).
  • In Vivo PK Consulting Expert advice on pharmacokinetics and how specific drugs affect the body to determine function, effectiveness, dosage size, etc…

Market Access

  • Market Access Materials Find general strategies and methods used to market a pharmaceutical product or device.
  • Study Start Up Consulting Request for RWE/HEOR/Market Access Study Start Up Consulting

Medical Communications

  • KEE Identification, Mapping & Engagement Planning Systematic process to identify, categorize, and strategically plan outreach to Key External Experts (KEEs) based on their influence, specialization, and research activity.
  • Medical Literature Reviews Systematic searching, appraisal, and synthesis of published scientific literature to generate evidence-based reports on a specific topic, disease, or treatment.
  • Medical Science Liaison (MSL) Support Support services for Medical Science Liaisons (MSL).
  • Medical Writing and Editing/Manuscript Development Communicate scientific, technical and health-related information to a range of audiences.
  • Patient Narratives Compliant collection and use of individual patient stories to illustrate the impact of a disease or treatment, often for training or empathy-building purposes.
  • Protocol and Study Reports Write protocol and study reports, specifically relating to the drafting, writing, and editing of Clinical Safety Reports.
Show all 8 in Medical Communications 2 more
  • Target Product Profile (TPP) A sponsor prepared document which summarizes the drug development program that is described in terms of the labelling concepts. This profile is a communication method used between the FDA and sponsor which can be used...
  • Toxicology Reports Create pre-clinical toxicology reports.

Model Development

  • In Silico PK-PD Modeling Quantitative modeling and simulations correlation of pharmacokinetic and pharmacodynamic endpoints in support of preclinical and clinical development.
  • Transgenic Models Create animal models engineered for use in a specific therapeutic area.

Oncology Models

  • Oncology Models Use model organisms to test the therapeutic efficacy of cancer drug candidates.

Real World Evidence & Data

  • Data Asset Validation Tools for validating that patient data and source has been accurately recorded.
  • Data Merging Tools for combining various data sets into a single data set. Includes data consolidation.

Regulatory Affairs

  • Regulatory Submission Documents Request services related to the submission and writing of New Drug Applications (NDA), Investigational New Drugs (INDs), and Investigator Brochures (IB) to the FDA and other regulatory bodies.

Regulatory Consulting

  • Toxicology Data Review Identify relevant toxicological endpoints for “No Observed (Adverse) Effect Level” (NO(A)EL) or “Lowest Observed (Adverse) Effect Level” (LO(A)EL).

Scientific Data Services

  • Discovery Computational Systems Biology Model the interaction of biological system with drug candidates.
  • Software Tools Software tool for statistical analysis, data mining, genome annotation or NGS data analysis.
  • Systems Pharmacology Understand how drugs interact with different molecular and cellular systems within biological models.

Specialty Dosing Routes

  • Inhalation Toxicology Measure toxicity by daily clinical observation, body weight, clinical chemistry, hematology, and terminal necropsy and pathology.

Target Animal and Human Food Safety

  • Toxicokinetic Analysis Determine the drug concentration at which off-target or toxic effects occur.

Other services

  • IND Writing Receive assistance with materials for an IND application.
  • NDA Writing Receive assistance in the NDA application process.
  • New Request  

Source: Scientist.com supplier network

Where it operates

Sites by country, with the cities in each.

  • United Kingdom Sheffield 1 site
  • United States Princeton 1 site

Source: Scientist.com supplier network (site locations)

About this supplier

In the supplier's own words, as listed in the Scientist.com network.

Certara is dedicated to improving healthcare by shortening the time it takes to successfully bring a new drug to market. We do this offering a broad spectrum of scientific consulting services and software products, with special focus on model based drug discovery and development. Certara was formed by acquiring and integrating Tripos, Pharsight, Simcyp, and Synchrogenix, complementary companies focused on model-based approaches in different phases of the drug discovery and development cycle, creating a company with unparalleled scientific and technical breadth from early drug discovery...

Show the full description

Certara is dedicated to improving healthcare by shortening the time it takes to successfully bring a new drug to market. We do this offering a broad spectrum of scientific consulting services and software products, with special focus on model based drug discovery and development.

Certara was formed by acquiring and integrating Tripos, Pharsight, Simcyp, and Synchrogenix, complementary companies focused on model-based approaches in different phases of the drug discovery and development cycle, creating a company with unparalleled scientific and technical breadth from early drug discovery through Phase IV clinical trials. Because of this, Certara is uniquely able to bring solutions forward that span the entire discovery and development cycle, eliminating traditional bottlenecks and impediments.

Website
www.certara.com

Source: Scientist.com supplier network, written by the supplier

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Sources: Scientist.com supplier network.

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