A new clinical trial site, was established in a suburban area of a large metropolitan area to address the growing demand for high-quality clinical research in underserved communities. The founders, a group of experienced physicians, were eager to begin enrolling patients but were unfamiliar with the complexities of FDA regulatory, legal, and compliance requirements. They reached out to the
Kulkarni Law Firm -Clinical Research
to guide them through the process and establish a strong foundation for their operations.
- Regulatory Complexity: Navigating FDA requirements for clinical trial sites, including IRB approvals, patient consent processes, and Good Clinical Practice (GCP) adherence.
- Compliance Gaps: Lack of a robust compliance program to address HIPAA, state laws, and federal regulations.
- Operational Readiness: No clear standard operating procedures (SOPs) or quality assurance mechanisms.
- Risk Management: Unawareness of potential legal liabilities and how to mitigate them.
Establish a Compliance Framework
- Comprehensive Compliance Program: Designed a tailored compliance program incorporating the DOJ's Corporate Compliance Program guidelines and OIG requirements, ensuring adherence to federal laws and FDA standards.
- Privacy Protections: Implemented a robust HIPAA and state law-compliant framework to safeguard patient data and avoid breaches.
- State Law Integration: Addressed variations in state laws governing clinical research, such as licensure requirements for investigators and telemedicine rules for remote trials.
Design Operational Excellence
- SOP Development: Created detailed SOPs for critical functions, including patient recruitment, adverse event reporting, and data management.
- IRB Coordination: Guided the site through obtaining Institutional Review Board (IRB) approvals for studies, ensuring alignment with FDA guidelines.
- Training Programs: Conducted training for investigators and staff on GCP, informed consent, and compliance best practices.
Build Your Risk Management
- Legal Risk Assessment: Evaluated contracts, including Clinical Trial Agreements (CTAs), for indemnity clauses, intellectual property rights, and payment structures.
- Fraud and Abuse Prevention: Educated the site on the False Claims Act and Anti-Kickback Statute, providing strategies to avoid violations.
- Audit Preparation: Prepared the site for sponsor audits and FDA inspections, using a proactive approach to identify and mitigate potential deficiencies.
Corporate Activation Steps
- State Registration: Registered the site with the state
- EIN: Obtained a federal tax ID (EIN)
- Insurance: Reached out to the insurance broker to review requirements to evaluate whether supplemental insurance is required.
- Regulatory Readiness: The client’s clinical trial site successfully passed its first Sponsor site inspection with no significant findings, demonstrating sponsor confidence.
- Compliance Confidence: The comprehensive compliance program minimized risks related to data breaches, fraud, and regulatory violations.
How KLF Ensures Continued Success
- Ongoing Support: Monthly compliance reviews and legal consultations ensure the site stays updated on evolving FDA regulations and best practices.
- Education and Outreach: Regular training sessions for staff on new FDA guidance, state law changes, and emerging industry standards.
- Audits: Provide outsourced audits to review the site and identify issues that require additional oversight.
To learn more about how the Kulkarni Law Firm can set up your clinical trial site for success, visit www.kulkarnilawfirm.com or contact us today.
