For organizations engaged in clinical research, navigating the complex regulatory and contractual landscape that governs clinical trials is critical. From trial design to data collection, every stage requires precision, compliance, and collaboration across multiple stakeholders. Axiom’s clinical trials lawyers help pharmaceutical companies, academic medical centers, and clinical research organizations manage risk, protect innovation, and advance medical discovery with confidence.
Guiding Clients Through Every Phase of Clinical Research
Axiom’s lawyers can advise clients on the full lifecycle of clinical development, offering strategic counsel on contracting, ethics, and regulatory compliance. They have extensive experience supporting companies and institutions conducting trials at clinical research sites across the United States and globally.
Our lawyers can negotiate clinical trial agreements involving sponsors, principal investigators, and institutions, ensuring clear terms around responsibilities, data ownership, publication rights, and subject compensation. They can also draft and review consent forms and informed consents, ensuring compliance with both federal and state laws and alignment with Institutional Review Board (IRB) requirements.
Regulatory Insight and FDA Experience
The clinical research ecosystem operates under rigorous oversight from agencies such as the Food and Drug Administration (FDA). Axiom’s lawyers provide practical guidance on regulatory submissions, adverse event reporting, and inspection readiness. They help represent clients before regulators and IRBs, ensuring that clinical activities meet Good Clinical Practice (GCP) standards and ethical obligations.
Whether advising pharmaceutical companies on Phase I–IV trials or supporting academic medical centers conducting investigator-initiated research, Axiom’s clinical trials lawyers combine legal precision with operational understanding. They anticipate challenges, mitigate compliance risks, and help clients move from concept to commercialization more efficiently.
Protecting Innovation and Managing Collaboration
Intellectual property and data rights often sit at the heart of clinical trial partnerships. Axiom’s lawyers assist clients in protecting proprietary technology, trial methodologies, and confidential data through robust intellectual property and confidentiality provisions. They also advise on collaborations and licensing arrangements between sponsors and research institutions, ensuring that innovation is shared and safeguarded appropriately.
By aligning legal, ethical, and commercial considerations, Axiom’s lawyers enable life sciences companies and research institutions to advance clinical development without compromising compliance or patient trust.
Partnering with Life Sciences Leaders
Axiom’s clinical trials lawyers work with a diverse range of life sciences organizations, from emerging biotechs and pharmaceutical companies to global CROs and academic medical centers. They offer flexible, scalable legal support that adapts to the needs of fast-paced research environments, providing experienced counsel on-demand for regulatory filings, contract negotiation, and ongoing compliance oversight.
With a focus on precision, practicality, and protection, Axiom helps clients navigate the legal complexities of clinical development, empowering innovation and accelerating the path to market.
