Research

Overview

Whether as an academic medical center, research institute, cutting-edge physician practice, pharmaceutical company, device manufacturer, or clinical research organization, your focus is on medical breakthroughs and new treatment options that enhance patient care. We partner with you as you seek to ensure that your clinical research programs adhere to all accepted clinical trial guidelines, including clinical trial design and agreements, Food and Drug Administration approvals, and commercialization. We help you navigate institutional review board requirements and human-subject protection rules at both the federal and state levels. We can serve as an extension of your team to help you write grants, draft budgets, develop contracts, and manage data rights. We can help manage your clinical research compliance needs so that you can focus on scientific pursuits. Our attorneys, consultants, and other professionals work with clinical research organizations across the industry in the United States and internationally.

Insights & Events

Latest

最新 April 2026

FDA-Related Legislative and Regulatory Proposals and Funding Change the President's FY27 Budget

Between a Doorstop and a Starting Gun
121 min read
最新 February 2026

FDA Publishes Long-Awaited Draft Guidance on “Plausible Mechanism Framework” to Spur the Development of New Individualized Medicines

Anticipated Deadline for Comments Is April 27, 2026
7 min read
最新 December 2025

European Union’s Digital Omnibus Package, Part II — Changes to the GDPR and the Data Act

Key Changes Relevant to U.S. Businesses
9 min read
最新 November 2025

SCOTUS Weighs Trump Administration’s Tariff Authority Under IEEPA; Pharma and Device AI; and More

Biopharma & Medical Devices Briefing
7 min read
最新 August 2025

Effects of the One Big Beautiful Bill Act on Health Care and Pharma; and More

Biopharma & Medical Devices Briefing
7 min read
最新 June 2025

Texas Genomic Act: A New Era of Genetic Privacy Legislation

Including Prohibitions on Genetic Sequencing, Storage and Sale of Genomic Information
7 min read
最新 May 2025

FDA Identifies Data Quality and Study Conduct Concerns With Raptim Research and Requires Sponsors to Submit Replacement Study Data

Reminder of Importance of Adequately Vetting Contract Research Organizations
5 min read
媒体报道 February 2025

Doriann Cain Provides Insight in Navigating HIPAA Compliance With Becker’s Hospital Review

1 min read
最新 January 2025

FDA Issues Detailed Guidance for Biopharma Industry on What Information to Provide to FDA About Use of AI Models

A Seven-Step Process and Detailed Recommendations for Submissions
6 min read
最新 September 2024

Recap of the FDA and CTTI Public Workshop on AI in Drug Development

3 min read
Insights
最新 April 2026

FDA-Related Legislative and Regulatory Proposals and Funding Change the President's FY27 Budget

Between a Doorstop and a Starting Gun
121 min read
最新 February 2026

FDA Publishes Long-Awaited Draft Guidance on “Plausible Mechanism Framework” to Spur the Development of New Individualized Medicines

Anticipated Deadline for Comments Is April 27, 2026
7 min read
最新 December 2025

European Union’s Digital Omnibus Package, Part II — Changes to the GDPR and the Data Act

Key Changes Relevant to U.S. Businesses
9 min read
最新 November 2025

SCOTUS Weighs Trump Administration’s Tariff Authority Under IEEPA; Pharma and Device AI; and More

Biopharma & Medical Devices Briefing
7 min read
最新 August 2025

Effects of the One Big Beautiful Bill Act on Health Care and Pharma; and More

Biopharma & Medical Devices Briefing
7 min read
最新 June 2025

Texas Genomic Act: A New Era of Genetic Privacy Legislation

Including Prohibitions on Genetic Sequencing, Storage and Sale of Genomic Information
7 min read
最新 May 2025

FDA Identifies Data Quality and Study Conduct Concerns With Raptim Research and Requires Sponsors to Submit Replacement Study Data

Reminder of Importance of Adequately Vetting Contract Research Organizations
5 min read
媒体报道 February 2025

Doriann Cain Provides Insight in Navigating HIPAA Compliance With Becker’s Hospital Review

1 min read
最新 January 2025

FDA Issues Detailed Guidance for Biopharma Industry on What Information to Provide to FDA About Use of AI Models

A Seven-Step Process and Detailed Recommendations for Submissions
6 min read
最新 September 2024

Recap of the FDA and CTTI Public Workshop on AI in Drug Development

3 min read