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Biosimulation is quantitative drug development, also known as modeling and simulation.
Visualize clinical and non clinical data to improve drug development decisions
Increase efficiency for your regulatory preparation and submission process
Overcome the challenges to demonstrating and delivering value effectively
Improve discovery research data utilization and optimize design-make-test-analyze cycles
Advanced Deep Learning Analytics and AI
The industry gold-standard for pharmacokinetic / pharmacodynamic (PK/PD) analysis
User-friendly and powerful nonlinear mixed effect modeling software
Enhanced tools for in vitro-in vivo correlation studies to accelerate your drug development
Create complete pharmacokinetic (PK) regulatory submission-ready CDISC domains in minutes
Phoenix platform and Integral repository paired together for an end-to-end PK/PD validated SaaS offering in the cloud
Shorten protocol to submission times and improve end-to-end clinical trial data quality
Define, reuse & govern standards in our clinical metadata repository
Design and visualize CRFS and build your EDC in under 6 weeks
Reduce external vendor data timelines and get cleaner, higher quality data from vendors
Automate SDTM generation and make earlier informed decisions with rapid trial insights
Automate creation of define.xml and generate submission deliverables up to 80% faster
Ensure continuous compliance with in-stream data validation and monitor progress towards submission readiness
Simcyp PBPK models describe the behavior of drugs in different body tissues, with each tissue considered a physiological compartment
Versatile tool for translational modeling and simulation
De-risk your program with evidence-based secondary pharmacology insights
Predict Clinical Outcomes for Novel Targets, Modalities & Combinations
Streamline the identification and refinement of promising formulations in a cost-effective manner
Shorten the drug discovery design-make-test-analyze cycle with D360’s self service data and analytics
Solve data silo problems while improving analytics capabilities that drive productivity and accelerated data discovery across life science R&D
Software to inform key safety, efficacy and efficiency decisions throughout the entire development process
Empower complex decisions to streamline your path to approval with Certara’s leading quantitative analysis and predictive modeling
Achieve maximum value with expert support to extract insights from your biological data
We work alongside your team to inform critical decisions and set you up for regulatory and commercial success
Deliver successful submission documents on time, every time
Having the right regulatory strategy in place will save time and money, and may result in the acceleration of your drug development program
Accelerate submission success with customized scalable solutions
Reach the right audience at the right time with expert planning and writing support
Enhance patient engagement and maintain compliance with data anonymization solutions
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.
Engage with our QC, formatting, and publishing experts to ensure high quality across all your documents
Protect your submission with comprehensive support from a proven team of experts
Our real world data solutions allow for niche needs identification, justifying access, differentiating value, quantifying an opportunity an demonstrating benefit/risk of your product
Determine your products value with our best in class capabilities in modeling, simulation, mathematics & Bayesian statistics paired with advanced analytics frameworks & proprietary software
Showcase the real-world value of your product
Optimal drug pricing and reimbursment strategy
Implement your payer engagment strategy early and often for optimal reimbursment
Optimize your product value, positioning and evidence synthesis across all stages of the reimbursement journey
Derisk and accelerate the development of your cell and gene therapies–from discovery to market access–through an integrated approach and unmatched expertise
Tackle pediatric drug development challenges head on to ensure safe and effective medicines to children with our team of multidisciplinary experts
Trust the experts who advanced 500+ oncology projects in 2021
Overcome the unique challenges in rare disease and orphan drug development through an integrated approach to modeling and simulation
Maximize program efficiencies and increase the likelihood of regulatory success with Certara’s unmatched experience and expertise in complex biologics
Our Story
Certara is committed to understanding, monitoring, and managing our social and environmental responsibilities.
Many global regulatory agencies have adopted use of Certara’s Simcyp PBPK and Phoenix PK/PD platforms
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Learn how we helped solve our client’s drug development challenges
Read our experts’ thoughts on the latest industry & regulatory trends
Our blogs examine key issues in biosimulation and regulatory science
Bylines and contributions from Certara’s thought leaders
Read the latest happenings at Certara
Research authored by scientists at Certara
Helpful guidance and essential info to build your subject matter expertise
Catch up on the latest trends & best practices during our educational, interactive webinars
Stay on the cutting edge of model-informed drug development & regulatory science trends on your time
Connect with us during industry events at our booth or during our thought leadership presentations
Listen to our experts discuss drug discovery and development topics and trends
Explore on demand, live, and in-person PK/PD courses taught using Certara software Phoenix WinNonlin
Demonstrate your PK/PD expertise by obtaining a Certara Professional Certification
Get a solid grounding in mechanistic modeling and simulation
ISB 2001, a BCMA and CD38 dual targeting T cell engager, demonstrates superior cytotoxicity relative to teclistamab in the samples of patient relapsing from CD38 and BCMA targeted immunotherapies
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