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Clinical Research and Biosciences

Clinical Research and Biosciences


Overview

Smith Moore Leatherwood's clinical research and biosciences team provides a wide range of services to our clients engaging in clinical research, product development, and the sales and marketing process. Our work with sponsors and sites, such as teaching hospitals, academic medical centers, physician groups, and research entities, including site management organizations, provides us with a balanced view of the needs of each.  We also recognize the time sensitive nature of projects in the fast-paced arena of product development. We work closely with our clients to ensure that legal review does not unnecessarily hamper the process.

In addition to assisting our clients in bringing products to market, we also help our clients maintain regulatory compliance and assure that their interests are protected so their time and energy can be concentrated on the advancement of medical knowledge.  For example, we routinely advise clinical research and bioscience clients on:

  • Medicare billing compliance
  • Fraud and abuse issues
  • FDA regulations
  • Compliance with the PhRMA and AdvaMed codes of ethics and other industry guidance
  • Intellectual property protection
  • Tax-exempt status issues
  • Protection of human subjects and related privacy issues.

Our involvement with medical research activities is rewarding because it allows us to help create real health care benefits.  For more information on our clinical research and biosciences practice, please contact a member of our team.

Professionals

Attorneys

NAME TITLE LOCATION CONTACT
Partner, Technology Industry Leader
(336) 378-5356
Partner, Education Industry Leader
(336) 378-5331
Partner
(336) 378-5302
Experience

Representative examples of the work provided to our clinical research and biosciences clients include:
 

  • Drafted, reviewed, and negotiated Clinical Trial Agreements (CTAs), Confidentiality/Non-Disclosure Agreements, Research Consortia Agreements, Material Transfer Agreements, and Strategic Alliance and Joint Venture Agreements
  • Prepared compliance plans and policies to assist our biosciences clients in demonstrating compliance with OIG guidance and FDA regulations
  • Assisted health system clients in developing internal departments for administrative oversight of clinical trials
  • Advised site clients on fraud and abuse risks related to post-market and registry studies
  • Lead internal audits of hospital clinical research billing programs
  • Defended site clients under investigation for alleged Anti-Kickback Statute violations related to arrangements with independent physician groups performing clinical research related services
  • Provided training on compliance issues for health care sales representatives
  • Conducted comprehensive reviews of clinical research compliance programs, including human subject protections and Medicare reimbursement practices


* Past success does not indicate the likelihood of success in any future legal representation.

DISCLAIMER

Each of our lawyer's e-mail address is provided with his or her biography. If you are not a current client of our firm, you should not e-mail our lawyers with any confidential information or any information about a specific legal matter, given that our firm may presently represent persons or companies who have interests that are adverse to you. If you are not a current client and you e-mail any lawyer in our firm, you do so without any expectation of confidentiality. We will not establish a professional relationship with you via e-mail. Instead, you should contact our firm by telephone so that we can determine whether we are in a position to consult with you about any legal matters before you share any confidential or sensitive information with us.