Clinical Trials & Research
We provide comprehensive legal support to sponsors, research institutions, investigators, clinical research organizations (CROs), and other stakeholders involved in clinical research. We help clients navigate the complex legal landscape surrounding research collaborations with confidence.
We understand the intricacies of clinical trial agreements and are dedicated to ensuring your agreements align with regulatory requirements, protect your interests, and foster successful collaborations. Our services extend beyond clinical trial agreements to cover a wide range of legal issues related to clinical trials, including regulatory compliance, informed consent, IRB considerations, patient privacy, conflicts of interest, and risk management.
Contract Drafting and Negotiation
Well-crafted agreements play a critical role in the success of your research endeavors. We draft clinical trial, investigator-initiated research, and research collaboration agreements that address the unique needs of each party involved. We also negotiate terms to strike a balance that protects our client’s interests while fostering positive collaborations. Our commitment to efficiency ensures that your agreements are drafted, negotiated, and finalized in a timely manner, allowing you to stay on track with your research milestones.
Regulatory Compliance
Ensuring compliance with regulatory requirements and ethical standards is paramount in the clinical research space. We are well-versed in the vast array of regulations governing clinical trials. We ensure your clinical trial agreements comply with applicable regulatory standards relating to the development and conduct of clinical trials, including FDA regulations, the Common Rule, HIPAA, fraud and abuse laws, registration requirements, federal and state transparency reporting, and Good Clinical Practice (GCP) guidelines.
Informed Consent
Ensuring that informed consent documents align with legal and ethical standards is crucial. We assist in drafting and reviewing research consent forms, HIPAA authorizations, recruitment materials, and other subject-facing forms and provide legal guidance to meet regulatory requirements and protect the rights of clinical trial subjects.