Clinical Research Strategies, LLC is warming our virtual office for the arrival of our newest employee, Dulce Mariscal, PhD. ?? Stay tuned for her upcoming news release on Monday!
关于我们
Pittsburgh’s Premier Boutique Start-up CRO Partner | Clinical Research and Regulatory Strategy Management | CRO Due Diligence and Management | Trial Rescue | Executive Management Consultancy for Life Sciences
Assist new companies and life science/healthcare IT entrepreneurs with corporate start-up. Distill the complexities of regulatory and research disciplines into accessible terms for life science executives, entrepreneurs, and investors alike, who play a pivotal role in the development and investment of a new product, to improve its chances of clearing performance hurdles toward successful commercialization or exit.
Customize materials and presentations that offer a fundamental understanding of research from clinical study protocol development with statistical approach, costing and budgeting, site selection, study management, patient recruitment and outcomes, regulatory strategy, approvals, and reporting, risk management, reimbursement, publication, market adoption, and change to clinical practice guidelines. Specialties: corporation start-up and compliance, risk mitigation and assessments, clinical trial performance, CRO due diligence/selection/management, eTMF management and inspection-readiness, QA/audit for inspection-readiness; regulatory pathways, and ROI; assistance with due diligence; and, turnaround clinical trials and partnerships.
- 网站
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https://www.clinicalresearchstrategies.com
Clinical Research Strategies, LLC的外部链接
- 所属行业
- 生物技术研究
- 规模
- 11-50 人
- 总部
- Wexford，PA
- 类型
- 私人持股
- 领域
- Life Sciences、Clinical Development and Research Plans、FDA Negotiations and Submissions/IND Regulatory Agent、Medical Device Class I-III、Drugs and Biologics、CRO Selection and Management、Respiratory, Oncology, Critical Care, Surgery, Regenerative Medicine, Precision Medicine、Corporate Start-up、Foreign Direct Investment (FDI) - EU and China、US Transfer Pricing Regulations、Board of Directors Leadership、Staff Resourcing, Training, Coaching, Advancement、Business Development、Risk Assessment and Management、Fiscal Discipline and Pragmatic Forecasting、Legal Analysis, Contract Drafting, and Negotiations、HR Programs、CQI/CPI、Entrepreneurship、Corporate Policies and Operations、Partnerships and Advisory Boards、Innovation、CEO/COO Interim和TMF Management, QA/Audit for Inspection-Readiness
地点
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主要
获取路线
6400 Brooktree Court
Suite 240
US，PA，Wexford，15090
Clinical Research Strategies, LLC员工
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Tom Miller, PhD
Senior Vice President of Clinical Development at Enalare Therapeutics Inc.
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Matt Sundermann
Senior Clinical and Regulatory Affairs Scientist
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Julie Cramer, PhD, MS
Life Science Communicator, Innovation Facilitator, Program Manager, Problem Solver, Critical Thinker, Researcher
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Yuki Kinoshita
Clinical Research Associate at Clinical Research Strategies, LLC
动态
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CRS congratulates Alex Kunisky for completing his internship. Alex is a fourth-year PhD student in the Center for Neuroscience at the University of Pittsburgh. His research focuses on unraveling the molecular mechanisms behind Alzheimer’s Disease and its cognitive symptoms, aiming to identify novel approaches to prevent memory decline. He is also passionate about studying the biology of aging in general. Alex thanks our team for the opportunity to gain valuable experience working on various projects across CRS’s divisions and facilitating the internship. Please join the entire CRS team as we congratulate Alex! #internships #clinicalresearch
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CRS extends a well-deserved congratulations to Haley Fuller, PhD for her work anniversary and promotion to Senior Clinical and Regulatory Affairs Scientist! We are blessed to have her as part of the CRS team. #regulatory #clinicalresearch
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??Exciting news from Clinical Research Strategies, LLC! ?? ? We are thrilled to share that the first 2 participants in the Y-3-LC-06 study have completed study drug administration! ? A huge congratulations to our team members Anna Carpio, B.S. and Sidney Lane, PhD, Roger Morgan, MD FACS at MedSurgPI, LLC, the research site Tranquil Clinical Research and Consulting Services, our partner CRO Shanghai Bestudy Medical Technology Co., Ltd and the Sponsor, NeuroDawn Pharmaceutical Co., Ltd. for reaching this exciting milestone!?? ? We're incredibly proud of the hard work and dedication from everyone involved in this achievement. ? https://lnkd.in/e8Dp4nKk ? "[English Translation] R&D News | Our company's product Y-3 for injection has completed the first subject enrollment in the US Phase I clinical trial NeuroDawn Ningdan New Drug ? On February 19, 2025, our company's product Y-3 for injection completed the first subject administration at Tranquil Clinical Research in Texas, USA. ? This Phase I clinical study "A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetic Profiles of Y-3 in Healthy Adult Volunteers in the United States" (NCT06770491) plans to include 20 healthy subjects in the United States, aiming to evaluate the safety, tolerability and pharmacokinetic characteristics of Y-3 for injection in healthy subjects in the United States. After the Phase II results of Y-3 for injection were presented at the 2024 European Stroke Conference (ESOC 2024), it attracted widespread attention in the industry. Currently, Phase III clinical studies are being conducted in China (NCT06517173). Several other exploratory clinical studies are underway (NCT05849805, NCT06374667), and related articles have been published recently (Liu, W., et al., "Intracalvariosseous injection: an approach for central nervous system drug delivery through skull bone marrow with a preclinical research in stroke". eBioMedicine, 2025. 112.) Ningdan New Drug will continue to explore the clinical application of Y-3 for injection and promote global research and development layout."?
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CRS extends a heartfelt congratulations to Alyssa Harris, MS for her work anniversary and well-deserved promotion to Senior Manager of Clinical and Regulatory Affairs! We are blessed to have her as part of the CRS management team. #clinicalresearch #regulatory
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Congratulations, Setareh Aria Williams, on the three-year anniversary of Star Biopharma Consulting! Alethea Wieland and Clinical Research Strategies are honored to collaborate with you on real world evidence projects and more to come in the future!
Three years ago, I took a leap of faith, leaving my role as Global Head of Health Economics and Outcomes Research at a small biotech to start "Star Biopharma Consulting." Reflecting on this journey, I am immensely grateful for the incredible dream team we have built—bringing together subject matter experts in Medical Affairs, HEOR, RWE, Regulatory, Market Access, and staffing solutions https://lnkd.in/e94yXRJz ? Together, we have achieved remarkable milestones: 1. Supported 7 product launches across diverse therapeutic areas. Not only was the work rewarding but the client feedback served as a testimony to the quality of our work https://lnkd.in/exbpSV4r 2. Presented economic models on behalf of clients to over 100 hospitals and health systems, and at national and regional conferences. 3. Co-authored 8 peer-reviewed manuscripts in the last 3 years. If interested, you can read these here https://lnkd.in/eXBxPEHP ?4. Collaborated with my esteemed colleague, Alethea Weiland https://lnkd.in/diHC2ApD, on a webinar, “The Power of Real-World Evidence Accelerating Approvals in Global Markets”, where we shared best practices for leveraging RWE to support regulatory applications. https://lnkd.in/ewABJXZb ?5.??Participated in a podcast highlighting the experiences of women in science. ?6.?Paid it forward by serving the last 3 years on the Board of Association of Yale Alumni in Public Health, with a focus on preparing the next generation of epidemiologists for careers in the pharmaceutical industry. I’m looking forward to teaching a seminar there this spring. 7.?Overcame personal challenges, completing my first triathlon after recovering from a major accident https://lnkd.in/ejjtSvAe With clear goals, discipline, and persistence, anything is possible. This has been an extraordinary journey, and I am excited about the future as we continue expanding our team to help clients deliver impactful, high-quality studies. Our vision remains steadfast: to inform evidence-based decisions that improve market access and enhance patient outcomes Rich Weiss David Curry Russell Becker Diane Petrone Monica Bianchini
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Clinical Research Strategies, LLC (CRS) is kicking off our Human Factors Studies Program this week! Human factors testing helps medical device companies learn from errors in product use by typical end users and incorporates design improvements that aim to mitigate or eliminate errors which could cause harm or compromise medical treatment.? CRS is recruiting for volunteers to participate in testing to aid in the development of a wearable EEG sensor which is not yet FDA approved or cleared:? ?? Healthy Adults ?? Children with their Caregivers? ?? Health Care Providers (all skills/background)? To learn more about the EEG testing, and to sign up to be a human factors participant, please visit:?https://lnkd.in/ethfv_K3
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CRS Welcomes Our Newest Intern, Sierra Wilson! CRS has an Internship Affiliation Agreement with the University of Pittsburgh School of Medicine Graduate Studies to offer students opportunities to enhance their educational and career-oriented goals and experiences while providing a potential career trajectory opportunity. Our newest intern, Sierra Wilson is a 5th-year PhD candidate in the Cellular and Molecular Pathology Program at the University of Pittsburgh. Her research focuses on how liver cell ploidy affects responses to acute drug-induced liver injury, with an emphasis on acetaminophen toxicology mechanisms. She has broad interests in drug response, toxicology, and translational medicine, aiming to contribute to advancements in clinical research and therapeutic development. Please join the entire CRS team as we welcome Sierra! https://lnkd.in/gbKf9tJ2 #interns #mentoring #clinicalresearch
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CRS Welcomes Our Newest Intern, Derek Cracium! CRS has an Undergraduate Internship Affiliation Agreement with Penn State University to provide students with real-world clinical research experience that supplements what they learn in the classroom to expand their educational experiences and enhance their career objectives. Our newest intern, Derek Cracium, is a 4th-year Penn State undergraduate student studying Movement Science and Kinesiology. His passion for health and fitness stems from the belief that physical and medical wellness is relevant to everyone, having an impact on nearly every facet of our lives. He is motivated to expand his interest beyond fitness to clinical research, allowing medical professionals to provide the highest quality care. At CRS, he is excited to contribute to the process that ensures medical advancements progress safely and smoothly. Please join the entire CRS team as we welcome Derek! https://lnkd.in/gbKf9tJ2 #mentoring #interns #clinicalresearch
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Clinical Research Strategies, LLC congratulates Kaysie Foust on her two-year work anniversary! Kaysie is our Senior Clinical and Quality Specialist/Audit and continues to excel in her role. We appreciate all you do!
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