We are thrilled to welcome Catherine London to Leibowitz Law. ?With over a decade of experience in healthcare law, Catherine focuses on clinical trials, regulatory compliance, HIPAA, and fraud and abuse. She has already made a meaningful impact, helping us continue to provide exceptional service to our clients. Learn more about Catherine on our website.?
Leibowitz Law
律师事务所
West Conshohocken，Pennsylvania 54 位关注者
Boutique regulatory & transactional law firm | life sciences | clinical trials | technology commercialization
关于我们
We are a boutique regulatory & transactional law firm dedicated to the life sciences sector, concentrating on clinical trials and tech commercialization, including AI-driven technologies PRACTICE AREAS: Clinical research, regulatory compliance, technology & data, corporate & commercial CLIENTS: Sponsors/manufacturers of FDA-regulated devices, drugs & biologics; digital health companies; technology vendors; CROs; research institutions. Lead outside counsel for clinical trial operations, working with smart, research-driven clients committed to saving lives and enhancing quality of life NICHE: Contracts & counseling for clinical trials & digital health including CTAs, budgets, informed consent, HIPAA, CRO MSAs, core labs, rSDV, EDC, consulting, financial disclosure, DSMB, licensing, SaaS, wearables, website contracts, clickwraps & AI RISK MITIGATION: Highly skilled in indemnification, liability limits, insurance, subject injury, cyber risk & data rights NEGOTIATING EXCELLENCE: In-depth experience negotiating CTAs & related documents with universities, academic medical centers, medical practices and vendors. Skilled negotiators highly attuned to interpersonal dynamics & the unique motivations of each party STUDIES: IDE, IND, pre-market, post-market, on-label, off-label, registry, investigator-initiated, pediatric, HCT/P, HDE, preclinical & more WHY CHOOSE US? ? Sophisticated legal, regulatory & business guidance in a small firm setting ? Professional, knowledgeable, responsive ? Personable, curious, resourceful ? Well-informed on evolving legal, regulatory & business landscapes to help clients launch & manage clinical studies, regulated products & vendor services, and navigate the AI “Wild West” ? Start-up experience offering strategic insight tailored to emerging businesses ? We know the industry dynamics and stakeholder positions ? Our tailored approach meets your business needs & risk tolerance with practical strategies for swift contract resolution
- 网站
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https://leibowitzlawteam.com/
Leibowitz Law的外部链接
- 所属行业
- 律师事务所
- 规模
- 2-10 人
- 总部
- West Conshohocken，Pennsylvania
- 类型
- 私人持股
- 创立
- 2013
- 领域
- Clinical Trial Agreements, Budgets, FDA Regulatory, Fraud and Abuse, Indemnification and Risk Management, Informed Consent, HIPAA, CRO and Core Lab Services, Financial Disclosure, Privacy, GDPR, EDC, DSMB and CEC, Technology Law, Consulting and Professional Services, Intellectual Property, Licensing, General Contract Law.
地点
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主要
获取路线
300 Conshohocken State Rd
Suite 670
US，Pennsylvania，West Conshohocken，19248
Leibowitz Law员工
动态
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We are delighted to announce Katherine will present at Strafford’s CLE webinar next week. We hope you can join her! CLE credit is available. #clinicaltrialagreements #clinicaltrials #lifescienceslaw #clinicalresearch #CLE #strafford
Regulatory and Transactional Law for Life Sciences | Clinical Trials and Technology Commercialization
I’m pleased to invite you to join me and my co-presenters, Amanda Coulter and Kate Duffy Mazan, for an upcoming Strafford CLE webinar on Negotiating Clinical Trial Agreements. Date: Tuesday, November 19, 2024 Time: 1:00 – 2:30 p.m. EST This webinar is an excellent opportunity for sponsors and to enhance your understanding of key CTA provisions and how to balance the interests of sponsors and healthcare providers. Special offer: A 50% discount is available for friends and family. For more details and registration information, please click the link below. I hope to see you there. https://lnkd.in/eBKUePQd ? #Strafford #Clinicaltrialagreements #CLE #webinar
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We are thrilled to announce that Katherine Leibowitz will be speaking at the MAGI@home Clinical Research Conference. ? Join Katherine on Thursday, October 24, 2024, at 11:30 a.m. ET and Friday, October 25, 2024, at 11:30 ET from the comfort of your home or office. ? #MAGI #WCGMAGI #contracts #clinicaltrialagreements
Regulatory and Transactional Law for Life Sciences | Clinical Trials and Technology Commercialization
It’s back to school time!?Save up all of your burning questions about clinical trial agreements and join me for "Clinical Trial Agreements 103" and "Stump the Experts: Contracting and CTA Language" at MAGI@home Clinical Research Conference 2024!? I’m presenting Part Three of the CTA workshop (Wesley Warren and Conor Flynn are doing Parts One and Two).?The Clinical Trial Agreement 103 session is on Oct 24th at 11:30 a.m. ET. Because we can’t resist hard questions, join me again along with Phil Reed Boyce, JD and Wesley Warren on Oct 25th at 11:30 a.m. ET to Stump the Experts. I love WCGMagi. Interesting topics, friendly people, lots to learn, good times personally. Please join us. Register and learn more here. https://lnkd.in/ekAaTBph #MAGI #WCGMAGI #clinicaltrialagreements #contracts #indemnification #subjectinjury #insurance #limitationofliability
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As school winds down, we want to congratulate our hardworking intern, Zoe Dettelbach. She is graduating from Georgetown University Law Center this weekend. She has been an invaluable resource here at Leibowitz Law and we will be sad to see her go, but thrilled for her to start her legal career with Ropes & Gray LLP. We wish you the very best, Zoe!
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Have you thought about your #clinicaltrial operations and what you need to know about FDA’s final guidance on #DHTs??Check out our latest Insight by Katherine Leibowitz to learn about FDA’s latest thinking on digital health technologies used for remote data acquisition.? #digitalhealthtechnologies #dataacquisition #studyparticipants
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We are thrilled to announce that Katherine Leibowitz will be speaking alongside Leanne Tran at the session "Indemnification: Who, What, and WHY it Matters at the 2024 #WCGMAGI Clinical Research Conference! Join them Monday, April 15, in New Orleans, for an informative session that shares key considerations for sites & sponsors negotiating indemnification terms in a clinical trial agreement and provides a basic understanding of language to include and language to avoid when trying to draft favorable indemnification terms. Register and learn more here: https://lnkd.in/gV8r2wJs #WCGMAGI #contracts #clinicaltrialagreements
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