onlinehelp.certara.comCertara | Accelerating Medicines with Biosimulation and Tech-enabled Services

Software Software View All By Category Biosimulation Biosimulation is quantitative drug development, also known as modeling and simulation. Data Science Visualize clinical and non clinical data to improve drug development decisions Regulatory Increase efficiency for your regulatory preparation and submission process Market Access Overcome the challenges to demonstrating and delivering value effectively Discovery Informatics Improve discovery research data utilization and optimize design-make-test-analyze cycles Data Innovation Advanced Deep Learning Analytics and AI Phoenix™ PK/PD Platform Phoenix WinNonlin™ The industry gold-standard for pharmacokinetic / pharmacodynamic (PK/PD) analysis Phoenix NLME™ User-friendly and powerful nonlinear mixed effect modeling software Phoenix™ IVIVC Toolkit Enhanced tools for in vitro-in vivo correlation studies to accelerate your drug development PK Submit™ Create complete pharmacokinetic (PK) regulatory submission-ready CDISC domains in minutes Phoenix Hosted Phoenix platform and Integral repository paired together for an end-to-end PK/PD validated SaaS offering in the cloud Pinnacle 21 Enterprise Software Pinnacle 21 Shorten protocol to submission times and improve end-to-end clinical trial data quality Standards Management Define, reuse & govern standards in our clinical metadata repository CRF Design & EDC Build Design and visualize CRFS and build your EDC in under 6 weeks External Vendor Data Exchange Reduce external vendor data timelines and get cleaner, higher quality data from vendors SDTM Generation Automate SDTM generation and make earlier informed decisions with rapid trial insights Define.xml & Reviewer’s Guide Generation Automate creation of define.xml and generate submission deliverables up to 80% faster Clinical Data Validation Ensure continuous compliance with in-stream data validation and monitor progress towards submission readiness Simcyp™ Mechanistic Modeling Simcyp™ PBPK Simulator Simcyp PBPK models describe the behavior of drugs in different body tissues, with each tissue considered a physiological compartment Simcyp™ Discovery Versatile tool for translational modeling and simulation Simcyp™ Secondary Intelligence De-risk your program with evidence-based secondary pharmacology insights Simcyp™ Quantitative Systems Pharmacology Platform Predict Clinical Outcomes for Novel Targets, Modalities & Combinations Simcyp™ Biopharmaceutics Streamline the identification and refinement of promising formulations in a cost-effective manner D360™ Scientific Informatics Software D360 Shorten the drug discovery design-make-test-analyze cycle with D360’s self service data and analytics Certara.AI Platform Certara.AI Platform Solve data silo problems while improving analytics capabilities that drive productivity and accelerated data discovery across life science R&D View All Software Software to inform key safety, efficacy and efficiency decisions throughout the entire development process Services Services View All Model-informed Drug Development Modeling and Simulation Services Empower complex decisions to streamline your path to approval with Certara’s leading quantitative analysis and predictive modeling Biometrics and Data Sciences Achieve maximum value with expert support to extract insights from your biological data Drug Development Services We work alongside your team to inform critical decisions and set you up for regulatory and commercial success Regulatory Services and Medical Communications Medical Writing Deliver successful submission documents on time, every time Regulatory Consulting and Regulatory Affairs Having the right regulatory strategy in place will save time and money, and may result in the acceleration of your drug development program Regulatory Operations Accelerate submission success with customized scalable solutions Medical Affairs and Scientific Communications Services Reach the right audience at the right time with expert planning and writing support Transparency and Disclosure Enhance patient engagement and maintain compliance with data anonymization solutions Plain Language Documents From informed consent forms to plain language summaries, these documents ensure that the public is informed about clinical studies, and understands the value of their participation. Document Quality Engage with our QC, formatting, and publishing experts to ensure high quality across all your documents Submission Leadership Protect your submission with comprehensive support from a proven team of experts Real World Evidence and Market Access Consulting Real World Data Solutions Our real world data solutions allow for niche needs identification, justifying access, differentiating value, quantifying an opportunity an demonstrating benefit/risk of your product Decision Analytics and Modeling Determine your products value with our best in class capabilities in modeling, simulation, mathematics & Bayesian statistics paired with advanced analytics frameworks & proprietary software Health Economics and Outcomes Research (HEOR) Showcase the real-world value of your product Market Access and Pricing Optimal drug pricing and reimbursment strategy US and EU Payer Engagement Implement your payer engagment strategy early and often for optimal reimbursment Value and Strategy Optimize your product value, positioning and evidence synthesis across all stages of the reimbursement journey Specialty Areas Cell and Gene Therapy Derisk and accelerate the development of your cell and gene therapies–from discovery to market access–through an integrated approach and unmatched expertise Pediatrics Tackle pediatric drug development challenges head on to ensure safe and effective medicines to children with our team of multidisciplinary experts Oncology Trust the experts who advanced 500+ oncology projects in 2021 Rare Disease and Orphan Drug Overcome the unique challenges in rare disease and orphan drug development through an integrated approach to modeling and simulation Complex Biologics Maximize program efficiencies and increase the likelihood of regulatory success with Certara’s unmatched experience and expertise in complex biologics Our Story Why Certara Responsibility Certara is committed to understanding, monitoring, and managing our social and environmental responsibilities. Regulatory Adoption Many global regulatory agencies have adopted use of Certara’s Simcyp PBPK and Phoenix PK/PD platforms Locations Discover our global office locations Leadership Meet our Executive Team and Board of Directors Partnerships Our Centers of Excellence, Technology Partners, & Software Global Distribution Partners Careers Investors News Privacy and Legal Terms of Use As a visitor to Certara.com users can view the terms and conditions of this site. Privacy Center Our Privacy Center makes it easy to see how we collect and use your information Code of Conduct Our Certara Code of Conduct ensures that we hold ourselves and our business practices to a high standard, allowing us to fulfill our obligations to the many stakeholders we serve. Resources Resources View All Scientific Content Case Studies Learn how we helped solve our client’s drug development challenges White Papers Read our experts’ thoughts on the latest industry & regulatory trends Blogs Our blogs examine key issues in biosimulation and regulatory science Articles Bylines and contributions from Certara’s thought leaders Announcements Read the latest happenings at Certara Publications Research authored by scientists at Certara Fact Sheets Helpful guidance and essential info to build your subject matter expertise Webinars Catch up on the latest trends & best practices during our educational, interactive webinars On Demand Webinars Stay on the cutting edge of model-informed drug development & regulatory science trends on your time Conferences Connect with us during industry events at our booth or during our thought leadership presentations Podcast Listen to our experts discuss drug...