Clinical Research

We are passionate about ensuring access to ethical clinical trials for all patients because we truly believe that this is what leads to cures for cancer, heart disease and other rare medical diseases. To improve patient care, it is essential for us to provide legal guidance to healthcare organizations and people who are leading the charge on clinical trials during a time when the United States healthcare system is undergoing rapid and vast change.

 

Our Services:

President Tara Cowell’s expertise in clinical research for enterprises spans the last 20 years. She was a member and chair for over 10 Institutional Review Boards (IRB), including Children’s  IRBs.

In this capacity, she was dedicated to ensuring the protection of human subjects’ research participants, reviewed proposed studies, and raised questions and concerns to improve research studies for the protection of patients. Some of these studies resulted in treatments and cures for diseases.

  • Guidance on waivers and exemption requirements
  • HIPAA and Privacy guidance for research
  • Policy drafting for IRBs

 

 

Cowell has reviewed research agreements for all medical specialties, ensuring that they protect the hospitals and investigators participating in the trials, as well as the research subjects. Our services include:

  • Review Non-Disclosure Agreement process and template (including issues around non-employed physicians)
  • Review Clinical Trial agreements (CTA)
  • Prepare CTA templates
  • Prepare Master Agreements between the parties for hospitals using the same sponsor for multiple trials
  • Develop compliant, yet simple arrangements to allow payments to sub-investigators who are not employed while avoiding Stark and other legal risks
  • Draft and review agreements for non-research services that are paid for by clinical trial sponsors

 

Ensuring the safety of clinical research patients is the highest priority, and having in place appropriate policies and training for providers is critical. In this area, our services include:

  • Guidance and policies on humanitarian use devices
  • Guidance on emergency exceptions
  • Special requirements for vulnerable populations including children
  • Advice for Investigational Device Exemptions (IDE)
  • Advice for Investigational New Drug Applications (IND)

 

Animal research is an important component to help provide cures for patients in the future. Our services include:

  • Draft and review animal research policies
  • Provide guidance on animal research questions