In our latest webinar recording https://lnkd.in/gBzVf3Nu, Allucent experts explore the complexities of global pharmacovigilance (PV) operations, covering regulatory landscapes, best practices for compliance, and insights into building a robust PV system. This session is essential for both new and seasoned PV professionals so don’t miss this opportunity to enhance your knowledge and stay ahead in the ever-evolving world of pharmacovigilance. #Allucent #BringNewThearpiesToLight #Pharmacovigilance #RegulatoryCompliance #DrugDevelopment #ClinicalTrials #Webinar
关于我们
Allucent is on a mission to help bring new therapies to light by solving the distinct challenges of small and mid-sized biotech companies. The company is purpose-built through the convergence of leading providers to address this unmet need. Today, Allucent is a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics and clinical pharmacology across a variety of therapeutic areas. With more than 30 years of experience in over 60 countries, Allucent’s individualized partnership approach provides experience-driven insights and expertise to assist its clients in successfully navigating the complexities of delivering novel treatments to patients.
- 网站
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https://www.Allucent.com
Allucent的外部链接
- 所属行业
- 制药业
- 规模
- 1,001-5,000 人
- 总部
- Cary，North Carolina
- 类型
- 私人持股
- 领域
- Drug Development、Regulatory Affairs and Submissions、Clinical Strategy、Cell & Gene Therapy、Rare Diseases & Orphan Indications、Oncology & Hematology、Study startup & Feasibility、Regulatory Strategy、Small and midsized biotech companies、Biostatistics、Pharmacokinetics (PK) / Pharmacodynamics (PD)、Clinical Pharmacology、Medical/Scientific Writing、Protocol and study design、Medical monitoring、Patient recruitment、Pharmacovigilance、Data management、NDA/BLA/MAA和Product development
地点
Allucent员工
动态
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We're proud to work with THREAD in support of BARDA's DRIVe D-COHRe program! This DCT approach will help medical countermeasure developers recruit, enroll, and retain patients in settings outside the hospital and closer to the patient.
We’re thrilled to announce that THREAD, a leader in decentralized research and electronic clinical outcome assessments (eCOA), is partnering with Allucent, a global clinical research organization, to support their recent award from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Read the full press release: https://lnkd.in/gzESUpuf Together, we’ll be working on two pivotal initiatives: PROJECT REMOTE: A groundbreaking decentralized home-focused COVID-19 vaccine study aimed at enhancing patient accessibility and data collection. And the Decentralized Clinical Operations for Healthcare and Research Program Award: This initiative will further our commitment to innovative, patient-centric research practices. By leveraging our combined expertise, we’re dedicated to advancing the future of clinical trials and improving health outcomes for everyone, everywhere. #ClinicaResearch #DecentralizedResearch #eCOA #eCOAWithoutCompromise
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Allucent is honored to be recognized as a finalist for Best Contract Research Organization - Specialist Providers by the Scrip Awards. This nomination is a testament to the incredible dedication and expertise of our A-Team! We are humbled to stand next to other industry leaders, and we look forward to continuing our mission of delivering life-changing therapies to patients around the globe. ? #Allucent #BringNewTherapiesToLight #ScripAwards #CRO
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Psychedelics hold immense promise in the world of #CentralNervousSystem (CNS) interventions. Check out our newest blog: https://lnkd.in/g_apZ5Sd, where Allucent experts, Alison Wakeford, PhD, and Marcus Delatte, PhD, take a closer look at #psychedelics, reviewing products that are currently under investigation for various CNS indications, and the intrinsic pharmacology that makes these compounds increasingly interesting in the #neuroscience drug development landscape. ? #Allucent #BringNewTherapiesToLight #ClinicalResearch #Psychedelics #CNSResearch #Neuroscience
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Dive into the latest issue of Allucent's Monthly Newsletter for all the key biotech updates! Read it here: https://lnkd.in/gaWYsp9C ? ?? This month's Industry Spotlight features: ? ADCs, Bispecifics, and Radiopharma at the forefront of ESMO24 ? Important FDA approval dates to keep on your radar ? Innovations in Precision Oncology: Radionuclide Conjugates and ADC strategies ? A groundbreaking gene therapy startup receives the green light for a pioneering trial ? New FDA draft guidance on multiregional clinical trials in oncology ? Insights on who's thriving in the competitive biotech landscape For Business Queries, contact us: https://lnkd.in/gzwJy62X #Allucent #BringNewTherapiesToLight #ClinicalDevelopment #Newsletter
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Schedule a meeting here: https://lnkd.in/gE5CRj6p to join our study start-up expert Ashley Sullivan and her A-Team colleagues Jillian Milam, Audrey Vasseur and Andrew DeMaine at the upcoming OCT New England meeting in Boston! Visit us at booth #23, and make sure to check out Ashley's speaker session, "Driving Success through Well-Planned Study Start-up," on October 24th at 9:30am. #Allucent #BringNewTherapiesToLight #CRO #OCTNewEngland #ClinicalTrialOperations #DrugDiscovery
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The month of October marks Breast Cancer Awareness Month. Over 2 million women and men are diagnosed with breast cancer each year worldwide. Let's take time this month to continue spreading the word about the importance of regular screenings and supporting research efforts for a cure.? ? #BreastCancerResearch #BreastCancerAwarenessMonth #Allucent #BringNewTherapiesToLight #ClinicalTrials #DrugDiscovery
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With the implementation of AI on the rise across various industries, the versatility and vast potential of this tool could be a particularly big asset in the biotech industry. AI could have a considerable impact on integral factors of drug development, including GCP compliance and inspection readiness. Check out our podcast with BioPharma Dive where Allucent expert J Ernesto Vera-Sánchez Sanchez, PhD (VP, Head of GxP Strategy) examines this pertinent topic: https://lnkd.in/g4udPtqD. ? #Allucent #BringNewTherapiesToLight #ClinicalTrials #RegulatoryAffairs #ArtificialIntelligence #AI #GxP
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Join us for an insightful webinar that delves into the complexities of globalization in pharmacovigilance (PV). As pharmaceutical companies expand their operations worldwide, they face a myriad of challenges, including diverse regulatory requirements, language barriers, and an increasing volume of safety data. Our expert speakers Ian K. PhD, Georgia Kolangi, MSc, and J Ernesto Vera-Sánchez MD, PhD, MPH will provide a comprehensive analysis of the regulatory landscape across various regions, highlighting key differences and shared practices. You'll learn essential elements for establishing a robust global PV system and understand the expectations of regulatory inspectors to ensure compliance and readiness for audits. This webinar is an invaluable opportunity for PV and regulatory professionals—whether you're new to the field or a seasoned expert—to deepen your knowledge and gain practical strategies for navigating the intricacies of global pharmacovigilance. ??Don’t miss this chance to stay informed and enhance your PV practices! Register today to secure your spot.??https://lnkd.in/gajsS4ec #Allucent #BringNewThearpiesToLight #Pharmacovigilance #RegulatoryCompliance #DrugDevelopment #ClinicalTrials
Pharmacovigilance in a Global Market: Key Compliance Strategies
www.dhirubhai.net
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Check out our recent blog https://lnkd.in/epU49ZSR where Allucent expert, Vanessa Beddo, PhD (VP, Global Head of Biostatistical Consulting), examines several key considerations to implementing crossover designs in #oncology from a statistical perspective. Crossover designs in oncology studies allow patients to crossover from placebo or standard of care (SoC) to the investigational product after disease progression on their randomized therapy. This approach has the potential to produce a measurable impact on overall survival (OS). #Allucent #BringNewTherapiesToLight #ClinicalTrials #Biostatistics #Oncology #StudyDesign
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