We are a boutique regulatory & transactional law firm dedicated to the life sciences sector, concentrating on clinical trials and digital health, 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
Company Details
- Employees
- 10
- Founded
- -
- Address
- 300 Conshohocken State Rd,
- Industry
- Law Practice
- NAICS
-
Offices of Lawyers
- Website
- clinicaltrials.law
- Keywords
- 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..
- HQ
- West Conshohocken, Pennsylvania
- Competitors
- City of Boston | Mayor's Office for Immigrant Advancement, Legacy Mortgage Group, Third Door Law LLP, Jump$tart Coalition for Personal Financial Literacy, Saleh Law Professional Corporation, Prestamos CDFI, Uvalde CISD Moving Forward Foundation, Steinbergs LLP, Solutions Corporate Law Clerk Services Inc., NASCEND.
Leibowitz Law Questions
Leibowitz Law's website is clinicaltrials.law
Leibowitz Law's LinkedIn profile is https://www.linkedin.com/company/leibowitzllc-clinicaltrials
Leibowitz Law has
10 employees.
View email and phone details for 10
employees at Leibowitz Law.
Leibowitz Law's industry is
Law Practice
Leibowitz Law's top competitors are
City Of Boston | Mayor's Office For Immigrant Advancement,
Legacy Mortgage Group,
Third Door Law Llp,
Jump$tart Coalition For Personal Financial Literacy,
Saleh Law Professional Corporation,
Prestamos Cdfi,
Uvalde Cisd Moving Forward Foundation,
Steinbergs Llp,
Solutions Corporate Law Clerk Services Inc.,
Nascend.
Leibowitz Law's categories are Law Practice
Leibowitz Law's founding year is 2013
