Healthcare Clinical Research

Marti Ellen Thurman, JD, CCRP

Healthcare Clinical Research Compliance Lawyer

Meet Marti Thurman, a well-versed Healthcare Research Lawyer and a Certified Clinical Research Professional, who passionately champions clinical research and the heroes who conduct it. She is honored to work alongside clinical trial participants in managing their legal obligations, starting with contracting. Her clients include hospitals and healthcare systems, as well as academic medical centers and research staff who participate in sponsored research and investigator initiated trials. She is also a seasoned litigator who has a proven highly successful winning track record for her clients.

SUBJECT MATTER EXPERT CONFERENCE SPEAKER

Invited Presentations

November 13, 2017, MAGI’s Clinical Research Conference – 2017 West, San Diego, CA: “Managing Risk with Contracts: Informed Consent, Subject Injury, Insurance & Indemnification”
February 11, 2019, ExL’s 14th Annual Clinical Trial Billing & Research Compliance Conference, New Orleans, LA: “Brightening the Sunshine Act: Research Physician Payments and Conflicts of Interest and the EU General Data Protection Regulation (“GDPR”) – What You Need To Know”

My Approach

At the Thurman Law Office, you, as a researcher, are recognized as the hero who is engaging in cutting-edge, life-saving work. You soldier ahead in the face of tough challenges such as regulatory hurdles, legal obstacles, and budgetary constraints. Ms. Thurman thrives at helping clinical trial participants manage their legal obligations, starting with contracting. She specializes in lowering the hurdles and eliminating the obstacles, wherever and to whatever extent possible to solve the problems and bring the law on your side. She is dedicated to understanding what outcomes you desire and to working diligently to achieving them on your behalf. She will work closely with you and your team to ensure that you are, and remain, in legal compliance on all aspects of your clinical research.

Timelines & Cost

Here you will have timeliness and cost-effectiveness.

Healthcare entities that perform clinical research require cost-effectiveness and thinking-outside-the-box approaches to ensure success in this competitive market. Ms. Thurman provides clients with remarkably tight, reliable contracting timelines and practical counsel to assist in helping them reach their objectives as well as protecting them from costly legal pitfalls. She has a broad understanding of the industry sector, combined with decades of experience with mediating and negotiating disputes in litigation, which enables her to consistently be able to successfully resolve difficult issues and bridge industry challenges to desirable outcomes. And surprising to some, she provides her legal contracting services at a reasonable competitive rate. She attributes this to personally witnessing how vital and needed clinical research is, and her commitment to helping to promote it however she can.

Experience

Ms. Thurman has extensive U.S. and global experience providing legal and regulatory counseling in most aspects of healthcare clinical research. For several years, she has provided legal advice to healthcare entities and their clinical trial teams as they brought new pharmaceutical, medical devices, and biotechnology products to market. In addition to clinical trial contracting, she advised companies of all sizes on complying with the numerous applicable legal and regulatory requirements and industry best practices to ensure that their operations were in compliance with many laws and regulations, including, but not limited to:

Anti-Kickback Statute
Civil Monetary Penalty
Clinical research contracting, including clinical trial agreements, material transfer agreements, data use agreements, confidentiality agreements and facility use agreements
EU General Data Protection Regulation (GDPR)
False Claims Act Fraud and abuse issues, including compensation arrangements with physician investigators
Good Clinical Practice (GCP)
Health Insurance Portability and Accountability Act of 1996 (HIPAA)
Informed consent, waivers and IRB review
Physician Self-Referral (Stark) Law
Physician Payments Sunshine Act
483 Observation and Warning Letters

A Teammate in Your Corner

Here you will have solid, experienced expert advice you can trust.

Healthcare clinical research is one of the most important and complex industries globally. Therefore, by necessity, it is heavily regulated both at the state and federal levels in the United States. Some serious negative consequences await healthcare researchers in non-compliance with many aspects of these regulations and laws. You need to ensure 100% legal compliance to avoid any legal pitfalls. Ms. Thurman’s expertise ensures your team’s legal compliance and navigates you safely through the murky, and potentially legally risky, waters by minimizing your risks in the complicated array of possible issues involving clinical research.

A Focus on Results

As a researcher, you are a hero engaging in cutting-edge, life-saving work. You face tough challenges in the form of regulatory hurdles, legal obstacles, and budgetary constraints. Ms. Thurman helps clinical trial participants manage their legal obligations, starting with contracting. Clients include hospitals and healthcare systems, as well as academic medical centers and research staff that participate in sponsored research and investigator initiated trials.

The First Step

The first step is the acknowledgement that you and your team need the assistance of an experienced legal expert to ensure you are operating in strict legal compliance and to protect you and your team against any potential legal risks when operating in an area that is fraught with legal pitfalls. Through Ms. Thurman’s expertise and thorough understanding of the applicable law, she will be able to provide you and your team with sound legal advice and solid contracting that will safeguard your company from liability and avoidable risks.

Get Started Today

Don’t wait! Legal matters can sometimes be overwhelming. Allow Ms. Thurman to tackle these so you can focus on your patients and conducting the study. Contact Ms. Thurman for a free initial phone consultation. Let her help strategize your best next steps to minimize risks. The sooner you have a plan of action, the better your chances of taking the correct steps to reach desirable outcomes.