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Certara

Certara

Unternehmensberatung

Radnor, Pennsylvania 67.353 Follower:innen

Transforming Drug Development for Good

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Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries.

Branche
Unternehmensberatung
Größe
1.001–5.000 Beschäftigte
Hauptsitz
Radnor, Pennsylvania
Art
Kapitalgesellschaft (AG, GmbH, UG etc.)
Spezialgebiete
model-based drug discovery and development, scientific informatics, PK/PD modeling and simulation, PBPK modeling and simulation, trial design, drug development, regulatory writing, quantitative systems pharmacology, clinical pharmacology, quantitative systems toxicology, transparency and disclosure, model-based meta-analysis, regulatory strategy, regulatory publishing, market access, health economics and outcomes research und real world evidence solutions

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Beschäftigte von Certara

Updates

  • Unternehmensseite für Certara anzeigen

    67.353 Follower:innen

    Great insights from Anaya Rehman at #PHUSE on the evolution of regulatory medical writing! As regulatory expectations shift, medical writers are more important than ever in ensuring clarity, compliance, and strategic alignment. We’re proud to see Certara recognized as a leader in this space. Our mission is to support sponsors with expert medical writing and regulatory strategies to navigate complexity and deliver results. What were your key takeaways from PHUSE this year? Share in the comments—we’d love to hear!

    Profil von Anaya Rehman anzeigen

    Clinical Disclosure Thought Leader | Health Data Privacy | Regulatory Affairs Professional | Medical Doctor

    This week, I had the wonderful opportunity to present at #PHUSE US Connect in Orlando! In my session, "Strategic Authoring in Clinical Study Reports to Leverage AI for Data Privacy and Public Disclosure" I presented on the critical role of clinical data privacy and how a proactive, disclosure-friendly SMART approach can streamline document authoring. We explored ways AI can improve accuracy and efficiency, backed by real-world examples that showcased key challenges and innovative solutions. Appreciate everyone who attended and contributed to the discussions! PHUSE US Connect was a fantastic conference - insightful sessions, engaging discussions, and a great chance to connect with industry peers. Truly enjoyed meeting so many passionate professionals and exchanging ideas. #RegulatoryAffairs #MedicalWriting #DataPrivacy #AI #Certara #Disclosure

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  • Unternehmensseite für Certara anzeigen

    67.353 Follower:innen

    📢 Certara is heading to the 2025 SCDM EMEA Conference in Brussels! Find us at Booth 9 from April 9-11, at this must-attend event for clinical data managers. See how the Pinnacle 21 Enterprise platform simplifies clinical data management, with faster cycle times, from study setup to database lock - resulting in faster drug development. Don't miss the opportunity to connect with our experts and discover how we can empower your research efforts. See you in Brussels! Get more details 👉 https://lnkd.in/esQg7S5t #ClinicalDataManagement #ClinicalTrials #Certara #Pinnacle21

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    67.353 Follower:innen

    Exiciting news! Dr. Chandra Prakash is joining us as a speaker at #Certainty by Certara this May in Philadelphia! With over 30 years of experience in drug metabolism and clinical pharmacology, Dr. Prakash—Principal Research Fellow at Agios—brings invaluable insights to the stage. Join us on May 8th (Day 2 of Certainty) as he presents: "Physiologically-Based Pharmacokinetic Model Development, Validation, and Application for Prediction of Mitapivat (AG-348) Drug–Drug Interactions." 𝗕𝗿𝗲𝗮𝗸𝗼𝘂𝘁 𝗦𝗲𝘀𝘀𝗶𝗼𝗻: PBPK Real World Applications Workshop 𝗧𝗶𝗺𝗲: 1pm-3pm ET Seats are filling fast—don’t miss this opportunity to learn from Dr. Prakash! Register now: https://lnkd.in/eg38yJvc

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  • Unternehmensseite für Certara anzeigen

    67.353 Follower:innen

    Struggling with SDTM dataset complexities from eCRF design to CDISC validation? Join our live webinar to discover how standardized metadata can: ✅ Automate submission-ready SDTM generation ✅ Validate data using health authority-aligned standards (CDISC/Regulatory) ✅ Streamline end-to-end workflows with traceable compliance 🗓️ April 3, 2025 | ⏰ 2:00 PM JST/KST Reserve your spot: https://lnkd.in/es2yZMGM #SDTM #ClinicalData #CDISC #RegulatoryCompliance

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  • Unternehmensseite für Certara anzeigen

    67.353 Follower:innen

    Meet Holly Dierkers, Associate Director of Program Management at Certara! With extensive experience in regulatory strategy and marketing applications, Holly guides clients through critical milestones, from IND submissions to regulatory approvals. Her expertise ensures a smooth path toward clinical trials, helping bring new therapies to patients faster. At Certara, Holly manages complex projects, aligning expectations, mitigating risks, and driving seamless collaboration between internal teams and clients. Her structured approach keeps drug development programs on track and optimized for success. 🎥 Watch her full interview to learn more: https://lnkd.in/ejcPH5eh 📩 Connect with Holly: https://lnkd.in/dqR6isfv #ProjectManagement #DrugDevelopment #RegulatoryStrategy #ClinicalTrials #Certara

  • Unternehmensseite für Certara anzeigen

    67.353 Follower:innen

    Exciting news from the #Simcyp team! Our latest updates to the Simcyp PBPK Simulator are now available for you to explore in our on-demand webinar. Building on the gold-standard in population-based physiologically-based modeling and simulation, Version 24 brings key enhancements to take our PBPK capabilities even further. 🔍 Key updates include: ✅ Structure-based Predictors ✅ ASK Simcyp GPT Chat ✅ Cloud-Based Simulation Platform ✅ Modern, Improved Interface Watch our on-demand webinar to learn all about the latest advancements: https://lnkd.in/ekpJA_37 #Pharmacokinetics #PBPK #DrugDevelopment

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    67.353 Follower:innen

    The 2025 AMCP Annual Meeting (March 31 - April 3) is upon us! Next week 4,000+ managed care and market access professionals will converge on Houston, Texas to network and explore the latest trends and strategies. We caught up with Maximilian Vargas, PhD, MBA to hear about the sessions he's most excited to attend. Skip ahead to hear more about: (0:31) Federal and state legislative sessions (2:53) - Accelerated approvals - where are we now? (5:22) - Access and reimbursement landscape for CAR-T cell and gene therapies If you're headed to AMCP, stop and talk to Certara's market access experts at Booth #615. You can schedule a meeting in advanced by visiting our event page. https://lnkd.in/esM-2aYd #AMCP #AMCP2025 #managedcare #pharmacy #marketaccess

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    67.353 Follower:innen

    We’re pleased to share a study in 𝗖𝗣𝗧: 𝗣𝗵𝗮𝗿𝗺𝗮𝗰𝗼𝗺𝗲𝘁𝗿𝗶𝗰𝘀 & 𝗦𝘆𝘀𝘁𝗲𝗺𝘀 𝗣𝗵𝗮𝗿𝗺𝗮𝗰𝗼𝗹𝗼𝗴𝘆 that explores innovative methods for assessing the benefit-risk profiles of antibody-drug conjugates (ADCs), specifically trastuzumab emtansine (T-DM1) and trastuzumab deruxtecan (T-DXd). The research uses 𝗺𝗼𝗱𝗲𝗹-𝗯𝗮𝘀𝗲𝗱 𝗺𝗲𝘁𝗮-𝗮𝗻𝗮𝗹𝘆𝘀𝗶𝘀 (𝗠𝗕𝗠𝗔) and the clinical utility index (CUI) approach, analyzing data from 103 clinical trials to optimize drug dosing. The CUI method balances how well the drug works (objective response rate) with any serious side effects (dose-limiting toxicity), confirming that the approved doses for T-DM1 (3.6 mg/kg) and T-DXd (5.4 mg/kg) offer a strong benefit-risk balance. This approach isn’t just limited to ADCs; it can be applied to other drug types, speeding up development and reducing costs. This methodology is a game-changer for continuous benefit-risk assessments in drug evaluation. Contributors: Innocent Gerald Asiimwe & Nour CHTIBA: Applied Pharmacometrics Training Fellowship Samer Mouksassi, Pharm.D., PhD, FCP: Certara Pillai Goonaseelan (Colin): Pharmacometrics Africa NPC Raimund Peter, Eunice Yuen & Venkatesh Pilla Reddy: Eli Lilly & Co Ltd Check out the full article: https://ow.ly/sQY950Vpfon #DrugDevelopment #ADCs #Pharmacokinetics #Pharmacology #ClinicalTrials #ModelBasedAnalysis #Innovation #Pharmacovigilance

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  • Unternehmensseite für Certara anzeigen

    67.353 Follower:innen

    Reserve your spot for the 2nd annual Certainty US 𝗰𝘂𝘀𝘁𝗼𝗺𝗲𝗿 𝗲𝘃𝗲𝗻𝘁 for exclusive access to Certara experts, industry leaders, and peers as we explore the latest innovations and opportunities to bring greater certainty to drug development. Spots are limited! Register here: https://lnkd.in/eg38yJvc

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  • Unternehmensseite für Certara anzeigen

    67.353 Follower:innen

    #Certainty by Certara is headed back to Philadelphia! Have you registered? Join us May 7-8, 2025, as we unite leading experts in biosimulation, clinical pharmacology, regulatory science, AI, and software development to discuss strategies and innovations that are driving greater certainty in drug development. The event will feature parallel learning tracks, each focusing on a key aspect of the development process: ✅ Seeing Further in Discovery and Non-Clinical Research ✅ Latest Advances in MIDD: Insights, Examples and Perspectives ✅ Clinical Data Flow for Faster Analysis and Submission ✅ Drug Development and Regulatory Strategy Be part of the conversation and secure your seat today: https://lnkd.in/eNiTGkgn #CertaintybyCertara

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