Clinical Research Services

The challenging patchwork of laws, regulations, and compliance requirements of clinical research can vary by location and funding source. To effectively navigate this intricate legal framework, thorough knowledge and understanding of the interplay of federal, state, and local law is necessary. Furthermore, as more clinical trials are conducted globally, an understanding of the impact of international laws and standards is also required. Our team of Dykema attorneys can help ensure compliance with complex regulatory requirements by:

• Negotiating confidentiality and nondisclosure agreements, clinical trial agreements, consortia agreements, collaboration agreements, material transfer agreements, data use agreements and other agreements used to facilitate and integrate research efforts across organizations.
• Providing insight into compliance with the Federal Common Rule for federally supported research.
• Advising regarding compliance with grant requirements under the National Institutes of Health, the Agency for Healthcare Research and Quality, and other federal and private funding sources.
• Assisting with the development of privacy and security solutions to protect the intellectual property ("IP") and assets, tangible and intangible, created to support or conduct research.
• Developing and implementing research-related policies, procedures and contract playbooks.
• Advising and supporting operations of Institutional Review Boards ("IRB"), including policy development, operational support, and regulatory readiness.
• Assisting with allegations of research misconduct, including support of an inquiry and/or investigation and guidance regarding reporting obligations.
• Providing training on research-related topics, including human subjects’ protection, contracting issues, IRB operations, research billing, research misconduct, management of deviations from compliance and grant compliance.
• Conducting and assisting with investigations related to protocol deviations or other regulatory non-compliance.
• Preparing for site audits by study sponsors, CROs, governmental agencies or accrediting bodies, such as AAHRPP.
• Evaluating and advising on technology, privacy and security issues related to research.
• Counseling on the legal landscape surrounding decentralized clinical trials, including through use of telehealth, mobile health applications, electronic data capture systems, and remote monitoring tools.
• Developing institutional data governance policies and inter-institutional data sharing frameworks, particularly for multi-site or multi-PI projects.
• Advising on legal and compliance considerations related to the use of research management and data capture systems (e.g., CRIO, REDCap, Veeva, and similar platforms).
• Providing guidance on electronic records and electronic signatures compliance, including audit trail requirements, system access controls, and documentation necessary to satisfy FDA regulatory expectations.
• Assessing research infrastructure, regulatory compliance, active study portfolios, and potential liabilities as part of transactional due diligence for acquisitions, affiliations, or joint ventures involving outpatient clinics, ambulatory surgery centers, hospitals, and other healthcare facilities.
• Providing guidance and support to clients regarding FDA inspections, including preparing responses to FDA 483s, interacting with FDA and providing support during regulatory meetings.
• Assisting clients with drafting responses to FDA Warning Letters, including the development of corrective action plans.
• Advising on regulatory and operational considerations related to emergency use, expanded access, and compassionate use of investigational drugs, biologics, and devices, including coordination with sponsors, Institutional Review Boards, and FDA, and assistance with identifying and preparing required documentation.
• Representing clients in government investigations.