Clinical Research

Jackson Walker is uniquely positioned to support clients engaged in clinical research activities both in Texas and nationwide. The team has extensive experience supporting regulatory, compliance, privacy, contractual, and ethics matters for clinical investigators, research institutions, clinical research organizations (CROs), and sponsors.

Jackson Walker’s clinical research group works across investigational drugs, devices, and vaccines, as well as research-related imaging studies, and is comfortable managing the unique requirements of decentralized or hybrid clinical research approaches. Our attorneys have specialized experience and training in bioethics, healthcare provider, FDA, intellectual property, and privacy matters, enabling the team to provide a full-service approach in the clinical research space.

The team supports clinical investigators, research institutions, CROs, and sponsors by, for example:

  • Drafting and negotiating clinical trial agreements;
  • Creating joint ventures of CROs and research-oriented physician groups;
  • Managing U.S. Food and Drug Administration’s (FDA) and other federal compliance requirements for both sponsors and investigators;
  • Addressing ethics and informed consent issues in different research settings;
  • Drafting privacy authorizations for study subject enrollment;
  • Managing procedural requirements for publication, recordkeeping, and reporting of research activities and results;
  • Addressing employment and other organizational matters involved in staffing research teams; and
  • Responding to potential research misconduct under both federal and state laws.

Practice Category

  • Negotiated clinical trial agreements for an investigator and research institution (investigational drug)
  • Negotiated clinical trial agreements for an investigator and research institution (investigational device)
  • Drafted clinical trial privacy authorization for an investigator and research institution
  • Responded to IRB Reportable Event investigation, with no adverse consequences to investigator
  • Reviewed and edited policies and procedures for principal investigators with clinical research organization
  • Supervised and coordinated external audit of research operations
  • Assisted an academic medical center to respond to a NIH audit of research grants
  • Assisted a CRO in ensuring HIPAA compliance
  • Represented a minority physician investor in the sale of a CRO
  • Drafting and negotiating clinical trial agreements with sponsors
  • Drafting and negotiating clinical trial program agreements with affiliated hospital
  • FDA compliance
  • HIPAA compliance
  • Ethics and informed consent
  • Clinical research staffing and employment
  • Decentralized clinical trials
  • Digital health technologies in clinical research
  • Joint ventures of community based Phase I clinical trials
  • Medicare reimbursement rules for clinical trials

Practice Category