The Clinical Trials Information System (CTIS) is reshaping the way clinical trials are conducted and managed in the European Union. With the January 31, 2025 deadline fast approaching, all ongoing clinical trials must be transitioned to CTIS to comply with the EU Clinical Trials Regulation (CTR). This shift promises increased efficiency, harmonization, and transparency—but also brings new challenges for sponsors, CROs, and researchers. Learn more in our latest article: https://lnkd.in/gsJXDegc #CTISReadiness #CTIS #CRO #ClinicalTrials #EURegulations #ClinicalResearch #PharmaCompliance #ClinicalTrialManagement #RegulatoryAffairs #Pharmacovigilance #ClinicalData #ClinicalOperations
Amarex Clinical Research, LLC, an NSF company
生物技术研究
Germantown,MD 2,446 位关注者
A full-service CRO expediting patient access to safe and efficacious clinical products.
关于我们
Amarex is a global, full-service Contract Research Organization (CRO), whose leadership team has significant expertise conducting biomedical research, and whose combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications. Amarex provides comprehensive services in Project Management (Phase I-IV, BE/BA, PK/PD), Regulatory Affairs (FDA Applications and meetings, Applications to International Health Authorities, GxP Compliance Audits), Clinical Operations, Adaptive Study Designs, Statistical Analysis, Data Management, Medical Monitoring, Safety and Pharmacovigilance, and General Consulting. Amarex can take your product through the entire approval process, from creating the regulatory approval strategy, to conducting trials, to writing the marketing approval application. Join our growing list of clients with approved products. Amarex provides high quality and cost efficient services. Sign-up to receive invites to webinars, training courses and the latest cutting-edge information on clinical trials: https://go.pardot.com/l/129231/2020-07-27/39ng9k
- 网站
-
https://www.amarexcro.com/
Amarex Clinical Research, LLC, an NSF company的外部链接
- 所属行业
- 生物技术研究
- 规模
- 1,001-5,000 人
- 总部
- Germantown,MD
- 类型
- 私人持股
- 创立
- 1998
- 领域
- Clinical Trials、Clinical Site Feasibility、Clinical Monitoring、Project Management、Data Management、Pharmacovigilance、Biostatistics、Regulatory Affairs、Medical Writing、Quality Assurance、Consultancy、Phase I- IV和rescue trials
地点
Amarex Clinical Research, LLC, an NSF company员工
-
Kush Dhody
?? Clinical Trial Design and Execution Strategy ?? Clinical Product Development Consulting ?? President, Amarex Clinical Research ?? Senior…
-
Sally Breisch
Owner (VP&COO), Amarex LLC
-
Patrick Burke
?? FDA Regulatory & Clinical Trial Services + Clinical Product Development + Product Marketing Approval + IND/IDE Strategies + Clinical CRO
-
Virginia Holochwost
Recruiter at Amarex Clinical Research, LLC
动态
-
**** Breaking News **** As we correctly predicted in our article last month (link below), CMS’s Local Coverage Determination (LCD) L36377 for wound care products, including Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), is now officially enforced. The final LCD notice period began on November 14, 2024, with the LCD slated to take effect starting February 12, 2025. This update underscores the critical need for comprehensive clinical data to secure reimbursement eligibility, eliminating any margin for uncertainty. Amarex, with expertise honed from over 100 wound care trials and a dedicated team of specialized professionals, is well-prepared to assist companies in this space. Our integrated approach enables companies to not only validate product efficacy but also navigate the streamlined path to achieving reimbursement coverage. With CMS’s criteria tightening, Amarex offers the essential guidance and support to help companies meet the high standards now required for reimbursement, ensuring a strategic advantage in this dynamic market landscape. Read more about adapting to CMS’s updated wound care coverage in our article from last month here: Amarex CRO - CMS Reimbursement Coverage in Wound Care: Adapt or Be Left Behind https://lnkd.in/gjnJQecD
CMS Reimbursement Coverage in Wound Care: Adapt or Be Left Behind
amarexcro.com
-
In clinical research, data consistency and regulatory compliance are non-negotiable. Our latest article explores the journey of converting raw clinical trial data into SDTM datasets, a structured format that enables seamless regulatory review and analysis. Discover the key steps, best practices, and real-time benefits of SDTM conversion to improve data integrity and streamline clinical trial submissions. https://lnkd.in/gExxzw6g #CRO #ClinicalTrials #DataManagement #SDTM #CDISC #RegulatoryCompliance #ClinicalData #Biometrics #ClinicalResearch #ClinicalTrialData #ClinicalDevelopment #DataStandardization #ClinicalOperations #RealTimeData #Pharma #Biotech #DataIntegrity #Amarex
From Chaos to Clarity: The Journey of Converting Raw Data into SDTM Datasets
amarexcro.com
-
Selecting the right CRO for your clinical trial is an extremely important choice. Regulatory non-compliance, data integrity issues, missed timelines, budget overruns, poor patient recruitment, quality control issues... These are just some of the risks to consider if you get it wrong. So how do you know you're selecting the right CRO? Help reduce the risk and stay informed with our straight forward guide. Available here - https://lnkd.in/gFVk4vxr #ClinicalTrials #CRO #RegulatoryCompliance #DataIntegrity #PatientSafety #Pharma #Biotech #LifeSciences #DrugDevelopment #MedicalResearch #ClinicalResearch #ClinicalOperations #QualityControl #ClinicalTrialManagement
-
Explore the latest paradigm shift in oncology clinical trial design, driven by advances in cancer research and immunology and learn how evolving trial methodologies are enhancing cancer therapy development and patient outcomes.
White Paper: An Emerging Paradigm Shift in Oncology Clinical Trial Design
www2.nsf.org
-
CMS reimbursement requirements for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) are raising the bar for compliance and effectiveness. This shift presents both challenges and opportunities—companies must act now to meet these new standards. Read more in our article on how you can navigate these policy changes, and discover how Amarex can help you. #WoundCare #ClinicalTrials #CMS #Medicare #RegulatoryCompliance
Navigating the New Medicare Policy for HCT/Ps in Wound Care
Amarex Clinical Research, LLC, an NSF company,发布于领英
-
Our time to shine at the 21st BioPharma Clinical Trials Nexus. Sr Director Patrick Burke providing practical strategies and key insights on clinical trials for small to mid-size companies. Contact us to learn more - https://lnkd.in/gPZNc2rb
Discover how small biopharma companies can thrive with tailored CRO solutions! Patrick Burke, Sr. Director at Amarex Clinical Research, LLC, an NSF company, is sharing his insights on “Finally, the CRO for Small Biopharma” at the 21st BioPharma Clinical Trials Nexus in Somerset, NJ, October 22-23. Get ready for practical strategies and innovative solutions that empower smaller players in the industry. #BioPharma #ClinicalTrials #SmallBiopharma #CRO #InnovationInHealthcare #AmarexClinicalResearch #BiotechSolutions #PharmaGrowth #ClinicalDevelopment #BiopharmaConferences
-
Patrick Burke, Senior Director at Amarex, an NSF company, will be a featured panelist in a discussion at the 21st Biopharma: Clinical Trials Nexus in Somerset, New Jersey. : “Running Clinical Trials in Different Geographic Regions: Assessing Opportunities and Challenges” ?? October 22, 2024 | ?? 2:15 PM – 2:55 PM EDT This event brings together industry leaders to explore the complexities of running clinical trials across diverse global regions. Don’t miss the chance to gain valuable insights from Patrick and other distinguished panelists, moderated by Lisa Fitzgerald.
-
Are you looking for a CRO for your next clinical trial? Wondering how to choose the right one? When it comes to clinical trials, your CRO partner plays a pivotal role in regulatory compliance, cost-efficiency, and overall trial success. Download our guide to learn 11 Key Factors you need to consider before you make your choice https://lnkd.in/gFVk4vxr
-
We're excited to support and participate in the upcoming 21st Biopharma: Clinical Trials Nexus on October 22, 2024, organized by Nexus Conference. Our very own Patrick Burke will be presenting "Finally, the CRO for small BioPharma", where he will cover some of the key insights that need to be considered when evaluating a CRO for your clinical trial. #ClinicalTrialsNexus #21stBiopharma #BiopharmaConference #Biopharma2024 #BiopharmaNexus #ClinicalTrials #ClinicalResearch #ClinicalTrialsAPAC #ClinicalTrialsUSA #CRO