Clinical Research,
Legal Excellence
Navigating complex regulations with expert legal guidance for
sponsors, CROs, sites, and research institutions.
Clinical Research
Compliance Program Development
Clinical Trial Agreement
Clinical Trial Privacy
Clinical Trial Pharmacy
Compliance Program Development
Establishing robust compliance frameworks for clinical research
Clinical trials must meet strict FDA, OIG, and DOJ regulations. We help Sponsors, CROs, SMOs, and sites comply. Additionally, in building various types of clinical research compliance programs, you encounter even more regulations and agencies such as OHRP, ORI, GCP, AAHRPP, and OCR. Here, we assist AMCs, research centers, and HRPPs maintain compliance.
Documentation
- Policy and Procedure Development
- Program Operational Support Audit Report
Services
- Gap Analysis
- Audits and Training
- Accreditation
Clinical Trial Agreements
Drafting and negotiating comprehensive research agreements
We negotiate and draft critical agreements for clinical trial sites, SMOs, CROs and sponsors.
Documentation
- Clinical Trial Agreements
- Data Privacy Agreements
Services
- Legal Negotiation and Drafting
Clinical Trial Privacy
Protecting patient data and ensuring regulatory compliance
We help FDA-regulated companies safeguard patient data and ensure compliance with privacy regulations like state, federal and international privacy requirements such as HIPAA.
Documentation
- Privacy Impact Assessments
- Data Sharing Agreements
Services
- Privacy Risk Assessments
- Privacy Policies Development
Clinical Trial Pharmacy
Ensuring compliance with pharmacy regulations in clinical trials
We help sites, sponsors, and CROs meet FDA, OIG, and state requirements and address best practices related to clinical research pharmacies.
Documentation
- Compliance Action Plans
- SOP Development
Services
- Compliance Strategy Development
- Corrective Action Implementation
Why Legal Representation Matters
Legal help is key in clinical research
Protection
Attorney-client privilege keeps discussions safer than regular confidentiality.
Comprehensive Advice
Covers FDA rules, privacy laws, and updates from agencies like OIG and DOJ.
Compliance Support
An attorney ensures compliance, protects your interests, and supports innovation.
Protection
Attorney-client privilege keeps discussions safer than regular confidentiality.
Comprehensive Advice
Covers FDA rules, privacy laws, and updates from agencies like 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.
