Clinical Trial Sites,
Legal Excellence
Healthcare professionals and clinical research sites with
confidence in navigating regulations.
Clinical Trial Site
Regulatory Compliance Guidance
Contract Support
Data Privacy and Security
Defending Sites/Investigators
Regulatory Compliance Guidance
Navigate FDA regulations and Good Clinical Practice (GCP) guidelines
We help HCPs navigate the complexities of FDA regulations and Good Clinical Practice (GCP) guidelines, ensuring your clinical trials meet all necessary compliance standards.
Documentation
- DOJ/ OIG Compliant Policies
- FDA/ ORI/ OCR Compliant Policies
- State law compliant Policies
Services
- Regulatory Audit Preparation
- FDA Inspection Management
- Data Privacy & Security Audits
Contract Support
Ensure fair, balanced agreements aligned with your interests
Sites must ensure that clinical trial agreements and other agreements are fair, balanced, and aligned with your best interests. The Kulkarni Law Firm advises clients with these interests
Documentation
- Clinical Trial Agreements (CTAs)
- Vendor Contracts
- Material Transfer Agreements (MTAs)
Services
- Contract Negotiation Support
- Confidentiality and IP Protection
- Contract Lifecycle Management
Data Privacy and Security
Comply with federal and state medical privacy laws
Healthcare providers must not only comply with federal medical privacy laws like HIPAA, but may also need to comply with state specific medical privacy laws like CMEA. Furthermore marketing may impact other privacy laws including CCPA/ CPRA, state wiretapping laws and more. Its important that.
Documentation
- Privacy and Marketing Policies
- Website Terms and Conditions
- Data Processing Agreements (DPAs)
Services
- Privacy Impact Assessments (PIAs)
- Data Anonymization Services
- Data Subject Rights Management
Defending Sites/Investigators
Respond to regulatory agency audits with site-specific strategies
Clinical trial sites may need to respond to audits from a variety of regulatory agencies including the FDA, OIG, ORI, OCR, and DOJ. The Kulkarni Law Firm helps develop site specific responses.
Documentation
- Response Letters to Regulators
- Compliance Action Plans
- Appeal Documents for IRB Decisions
Services
- Legal Representation in Investigations
- Regulatory Compliance Advice
- Dispute Resolution and Mediation
Why Legal Representation Matters
Compliance with legal and regulatory requirements is essential for
clinical research practices in physician offices
Attorney-Client Privilege
Ensures critical discussions and sensitive information are protected beyond the scope of standard confidentiality agreements.
Comprehensive Legal Guidance
Encompasses adherence to FDA guidelines, privacy laws, and evolving regulatory frameworks from agencies such as the OIG and DOJ.
Compliance Support
An attorney ensures compliance, protects your interests, and supports innovation.
Why Choose the
Kulkarni Law Firm?
Contact the Kulkarni Law Firm for practical and legal guidance.
Experience
20+ years as an attorney, pharmacist, and compliance expert.
Expertise
Author, podcaster, and educator on clinical research.
Education
Teaches at Drexel, Temple, and other universities.
